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出境医 / 临床实验 / Graded Motor Imagery in Elbow Limitation

Graded Motor Imagery in Elbow Limitation

Study Description
Brief Summary:
This randomized-controlled trial aims to investigate the efficacy of Graded Motor Imagery (GMI) on function, pain, and range of motion (ROM) in patients with a posttraumatic stiff elbow.

Condition or disease Intervention/treatment Phase
Elbow Fracture Limitation, Mobility Pain, Postoperative Upper Extremity Problem Other: Graded Motor Imagery Other: Standard Rehabilitation Other: Home Exercise Program Other: Cold Application Not Applicable

Detailed Description:
To investigate the efficacy of GMI on function, pain, and ROM in elbow limitation, voluntary patients with elbow limitation, aged between 20-55 years will be randomly divided into two groups: GMI group and standard rehabilitation (SR) group. Interventions will be applied for 12 sessions. The patients will be assessed before, after six-week treatment and six-week follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. ROM will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer of elbow flexors and extensors. Grip strength will also be assessed. Recognise™ will be used for assessing the right-left discrimination. The functional status and kinesiophobia will be evaluated by Disabilities Arm, Shoulder and Hand (DASH) and Tampa Scale for Kinesiophobia, respectively. The Global Rating of Change will be used to evaluate patient satisfaction. The Vividness of Movement Imagery Questionnaire 2 (VMIQ-2) will be used for evaluating the individuals' ability to mental imaginary.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Graded Motor Imagery Training in Elbow Limitation
Actual Study Start Date : October 15, 2019
Actual Primary Completion Date : October 1, 2020
Estimated Study Completion Date : July 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Graded Motor Imagery
Each subject in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, and home exercises.
Other: Graded Motor Imagery
The first stage of GMI includes laterality reconstruction. Patients will view and determine if the various images of body parts to image portrays the right or left side. The second stage targets activation of the primary motor cortex by imagine moving the involved body part. The final stage involves that the patient watches the unaffected body part moving in a mirror to "trick" the brain into thinking the affected body part is actually moving in a pain-free way. This will be applied for 6 weeks.

Other: Home Exercise Program
Proprioception exercises for the elbow. Scapulothoracic strengthening exercises. This will be applied for 6 weeks.

Other: Cold Application
Cold application around the elbow joint for 15 minutes in every session.

Active Comparator: Standard Rehabilitation
Each subject in the Standard Rehabilitation group will receive a treatment protocol consisting of stretching and strengthening exercises, cold therapy, and home exercises.
Other: Standard Rehabilitation
Shoulder, elbow and wrist AROM exercises. Elbow flexion and extension, and wrist flexion and extension stretching exercises. Elbow and wrist strengthening exercises. Grip strengthening exercises. This will be applied for 6 weeks.

Other: Home Exercise Program
Proprioception exercises for the elbow. Scapulothoracic strengthening exercises. This will be applied for 6 weeks.

Other: Cold Application
Cold application around the elbow joint for 15 minutes in every session.

Outcome Measures
Primary Outcome Measures :
  1. Functional Status [ Time Frame: After the six-week intervention ]
    The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.


Secondary Outcome Measures :
  1. Pain Intensity [ Time Frame: Baseline ]
    Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.

  2. Pain Intensity [ Time Frame: After the six-week intervention ]
    Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.

  3. Pain Intensity [ Time Frame: 6-week follow-up ]
    Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.

  4. Active Range of Motion (AROM) Assessment [ Time Frame: Baseline ]
    The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.

  5. Active Range of Motion (AROM) Assessment [ Time Frame: After the six-week intervention ]
    The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.

  6. Active Range of Motion (AROM) Assessment [ Time Frame: 6-week follow-up ]
    The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.

  7. Functional Status [ Time Frame: Baseline ]
    The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.

  8. Functional Status [ Time Frame: 6-week follow-up ]
    The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.

  9. Fear of movement (kinesiophobia) [ Time Frame: Baseline ]
    Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia. It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree). The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.

  10. Fear of movement (kinesiophobia) [ Time Frame: After the six-week intervention ]
    Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia. It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree). The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.

  11. Fear of movement (kinesiophobia) [ Time Frame: 6-week follow-up ]
    Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia. It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree). The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.

  12. Patient Satisfaction [ Time Frame: After the six-week intervention ]
    Patient satisfaction regarding improvement in elbow function will be assessed by the Global Rating of Change scale. The participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly in this study.

  13. Right-Left Discrimination [ Time Frame: Baseline ]
    Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination'). The test will be repeated three times and average values will be recorded.

  14. Right-Left Discrimination [ Time Frame: After the six-week intervention ]
    Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination'). The test will be repeated three times and average values will be recorded.

  15. Right-Left Discrimination [ Time Frame: 6-week follow-up ]
    Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination'). The test will be repeated three times and average values will be recorded.

  16. Vividness of Movement imagery Questionnaire-2 (VMIQ-2) [ Time Frame: Baseline ]
    The Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) will be used to measure the vividness of imagery. It comprises three subscales and 12 core questions that are scored on a 5-point Likert-type scale (Perfectly clear and as vivid (as normal vision or feel of movement) - No image at all, you only "know" that you are thinking of the skill). The subscales scores (External Visual Imagery, Internal Visual Imagery, and Kinaesthetic imagery) are ranged from 1 to 60, where the higher scores indicate a decreased ability of vividness of imagery.

  17. Pain pressure threshold [ Time Frame: Baseline ]
    Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. The process will be repeated three times in each direction, with the average value recorded.

  18. Pain pressure threshold [ Time Frame: After the six-week intervention ]
    Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. The process will be repeated three times in each direction, with the average value recorded.

  19. Pain pressure threshold [ Time Frame: 6-week follow-up ]
    Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. The process will be repeated three times in each direction, with the average value recorded.

  20. Muscle strength [ Time Frame: After the six-week intervention ]
    Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.

  21. Muscle strength [ Time Frame: 6-week follow-up ]
    Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.

  22. Grip strength [ Time Frame: After the six-week intervention ]
    Grip strength will be assessed with JAMAR hydraulic hand dynamometer. The process will be repeated three times in each direction, with the average value recorded.

  23. Grip strength [ Time Frame: 6-week follow-up ]
    Grip strength will be assessed with JAMAR hydraulic hand dynamometer. The process will be repeated three times in each direction, with the average value recorded.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects will be included with

  • Aged between 20 and 55 years
  • Elbow fracture in the six months before the study
  • Elbow limitation in flexion or extension
  • Being a volunteer to participate
  • Fractures should be managed with surgically
  • The "Standardized Mini Mental Test" result must be at least 24 points

Exclusion Criteria:

  • Malunion or Nonunion Fracture
  • The occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
  • Non-healing wound or infection
  • Previously received physiotherapy for elbow limitation
  • Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
  • Could not adjust to the treatment
  • Shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity
  • Having severe visual loss
Contacts and Locations

Locations
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Turkey
Istanbul University-Cerrahpasa
Istanbul, Bakırkoy, Turkey, 34147
Sponsors and Collaborators
Istanbul University-Cerrahpasa
Investigators
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Principal Investigator: Tansu Birinci, MSc Istanbul University-Cerrahpasa
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date June 2, 2021
Actual Study Start Date  ICMJE October 15, 2019
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
Functional Status [ Time Frame: After the six-week intervention ]
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.
Original Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
Functional Status [ Time Frame: After the six-week intervention ]
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Pain Intensity [ Time Frame: Baseline ]
    Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
  • Pain Intensity [ Time Frame: After the six-week intervention ]
    Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
  • Pain Intensity [ Time Frame: 6-week follow-up ]
    Pain intensity will be measured using the visual analogue scale (VAS). The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain. The score will be determined by measuring the distance on 10 cm line using a ruler. The higher scores indicate an higher level of pain.
  • Active Range of Motion (AROM) Assessment [ Time Frame: Baseline ]
    The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.
  • Active Range of Motion (AROM) Assessment [ Time Frame: After the six-week intervention ]
    The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.
  • Active Range of Motion (AROM) Assessment [ Time Frame: 6-week follow-up ]
    The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.
  • Functional Status [ Time Frame: Baseline ]
    The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.
  • Functional Status [ Time Frame: 6-week follow-up ]
    The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH). It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.
  • Fear of movement (kinesiophobia) [ Time Frame: Baseline ]
    Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia. It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree). The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.
  • Fear of movement (kinesiophobia) [ Time Frame: After the six-week intervention ]
    Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia. It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree). The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.
  • Fear of movement (kinesiophobia) [ Time Frame: 6-week follow-up ]
    Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia. It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree). The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.
  • Patient Satisfaction [ Time Frame: After the six-week intervention ]
    Patient satisfaction regarding improvement in elbow function will be assessed by the Global Rating of Change scale. The participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly in this study.
  • Right-Left Discrimination [ Time Frame: Baseline ]
    Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination'). The test will be repeated three times and average values will be recorded.
  • Right-Left Discrimination [ Time Frame: After the six-week intervention ]
    Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination'). The test will be repeated three times and average values will be recorded.
  • Right-Left Discrimination [ Time Frame: 6-week follow-up ]
    Right-Left Discrimination will be assessed with Recognise™ application. It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination'). The test will be repeated three times and average values will be recorded.
  • Vividness of Movement imagery Questionnaire-2 (VMIQ-2) [ Time Frame: Baseline ]
    The Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) will be used to measure the vividness of imagery. It comprises three subscales and 12 core questions that are scored on a 5-point Likert-type scale (Perfectly clear and as vivid (as normal vision or feel of movement) - No image at all, you only "know" that you are thinking of the skill). The subscales scores (External Visual Imagery, Internal Visual Imagery, and Kinaesthetic imagery) are ranged from 1 to 60, where the higher scores indicate a decreased ability of vividness of imagery.
  • Pain pressure threshold [ Time Frame: Baseline ]
    Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. The process will be repeated three times in each direction, with the average value recorded.
  • Pain pressure threshold [ Time Frame: After the six-week intervention ]
    Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. The process will be repeated three times in each direction, with the average value recorded.
  • Pain pressure threshold [ Time Frame: 6-week follow-up ]
    Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. The process will be repeated three times in each direction, with the average value recorded.
  • Muscle strength [ Time Frame: After the six-week intervention ]
    Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
  • Muscle strength [ Time Frame: 6-week follow-up ]
    Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors. The process will be repeated three times in each direction, with the average value recorded.
  • Grip strength [ Time Frame: After the six-week intervention ]
    Grip strength will be assessed with JAMAR hydraulic hand dynamometer. The process will be repeated three times in each direction, with the average value recorded.
  • Grip strength [ Time Frame: 6-week follow-up ]
    Grip strength will be assessed with JAMAR hydraulic hand dynamometer. The process will be repeated three times in each direction, with the average value recorded.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Pain Intensity [ Time Frame: Baseline ]
    Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
  • Pain Intensity [ Time Frame: After the six-week intervention ]
    Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
  • Pain Intensity [ Time Frame: 1-month follow up ]
    Pain intensity of the patients at rest, during activity, and at night will be assessed by Visual Analog Scale.
  • Active Range of Motion (AROM) Assessment [ Time Frame: Baseline ]
    The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.
  • Active Range of Motion (AROM) Assessment [ Time Frame: After the six-week intervention ]
    The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.
  • Active Range of Motion (AROM) Assessment [ Time Frame: 1-month follow up ]
    The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer. The process will be repeated three times in each direction, with the average value recorded.
  • Functional Status [ Time Frame: Baseline ]
    The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
  • Functional Status [ Time Frame: 1-month follow up ]
    The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
  • Fear of movement (kinesiophobia) [ Time Frame: Baseline ]
    Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale.
  • Fear of movement (kinesiophobia) [ Time Frame: After the six-week intervention ]
    Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale
  • Fear of movement (kinesiophobia) [ Time Frame: 1-month follow up ]
    Kinesiophobia of the patients will be assessed by Tampa Kinesiophobia Scale
  • Patient Satisfaction [ Time Frame: After the six-week intervention ]
    Patient Satisfaction will be assessed with the Global Rating of Change Scale.
  • Right-Left Discrimination [ Time Frame: Baseline ]
    Right-Left Discrimination will be assessed with Recognise™ application.
  • Right-Left Discrimination [ Time Frame: After the six-week intervention ]
    Right-Left Discrimination will be assessed with Recognise™ application.
  • Right-Left Discrimination [ Time Frame: 1-month follow up ]
    Right-Left Discrimination will be assessed with Recognise™ application.
  • Vividness of Movement imagery Questionnaire-2 (VMIQ-2) [ Time Frame: Baseline ]
    The Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) will be used to measure the vividness of imagery.
  • Pain pressure threshold [ Time Frame: Baseline ]
    Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry.
  • Pain pressure threshold [ Time Frame: After the six-week intervention ]
    Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry.
  • Pain pressure threshold [ Time Frame: 1-month follow up ]
    Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry.
  • Muscle strength [ Time Frame: After the six-week intervention ]
    Isometric muscle strength will be measured with a handheld dynamometer of four muscle groups (elbow flexors and extensors, and wrist flexors and extensors).
  • Muscle strength [ Time Frame: 1-month follow up ]
    Isometric muscle strength will be measured with a handheld dynamometer of four muscle groups (elbow flexors and extensors, and wrist flexors and extensors).
  • Grip strength [ Time Frame: After the six-week intervention ]
    Grip strength will be assessed with JAMAR hydraulic hand dynamometer.
  • Grip strength [ Time Frame: 1-month follow up ]
    Grip strength will be assessed with JAMAR hydraulic hand dynamometer.
  • Fine and gross motor hand function [ Time Frame: Baseline ]
    The Jebsen-Taylor Hand Function Test will establish to provide a standardized and objective evaluation of fine and gross motor hand.
  • Fine and gross motor hand function [ Time Frame: After the six-week intervention ]
    The Jebsen-Taylor Hand Function Test will establish to provide a standardized and objective evaluation of fine and gross motor hand.
  • Fine and gross motor hand function [ Time Frame: 1-month follow up ]
    The Jebsen-Taylor Hand Function Test will establish to provide a standardized and objective evaluation of fine and gross motor hand.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Graded Motor Imagery in Elbow Limitation
Official Title  ICMJE The Effectiveness of Graded Motor Imagery Training in Elbow Limitation
Brief Summary This randomized-controlled trial aims to investigate the efficacy of Graded Motor Imagery (GMI) on function, pain, and range of motion (ROM) in patients with a posttraumatic stiff elbow.
Detailed Description To investigate the efficacy of GMI on function, pain, and ROM in elbow limitation, voluntary patients with elbow limitation, aged between 20-55 years will be randomly divided into two groups: GMI group and standard rehabilitation (SR) group. Interventions will be applied for 12 sessions. The patients will be assessed before, after six-week treatment and six-week follow-up. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry. ROM will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer of elbow flexors and extensors. Grip strength will also be assessed. Recognise™ will be used for assessing the right-left discrimination. The functional status and kinesiophobia will be evaluated by Disabilities Arm, Shoulder and Hand (DASH) and Tampa Scale for Kinesiophobia, respectively. The Global Rating of Change will be used to evaluate patient satisfaction. The Vividness of Movement Imagery Questionnaire 2 (VMIQ-2) will be used for evaluating the individuals' ability to mental imaginary.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Elbow Fracture
  • Limitation, Mobility
  • Pain, Postoperative
  • Upper Extremity Problem
Intervention  ICMJE
  • Other: Graded Motor Imagery
    The first stage of GMI includes laterality reconstruction. Patients will view and determine if the various images of body parts to image portrays the right or left side. The second stage targets activation of the primary motor cortex by imagine moving the involved body part. The final stage involves that the patient watches the unaffected body part moving in a mirror to "trick" the brain into thinking the affected body part is actually moving in a pain-free way. This will be applied for 6 weeks.
  • Other: Standard Rehabilitation
    Shoulder, elbow and wrist AROM exercises. Elbow flexion and extension, and wrist flexion and extension stretching exercises. Elbow and wrist strengthening exercises. Grip strengthening exercises. This will be applied for 6 weeks.
  • Other: Home Exercise Program
    Proprioception exercises for the elbow. Scapulothoracic strengthening exercises. This will be applied for 6 weeks.
  • Other: Cold Application
    Cold application around the elbow joint for 15 minutes in every session.
Study Arms  ICMJE
  • Experimental: Graded Motor Imagery
    Each subject in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, and home exercises.
    Interventions:
    • Other: Graded Motor Imagery
    • Other: Home Exercise Program
    • Other: Cold Application
  • Active Comparator: Standard Rehabilitation
    Each subject in the Standard Rehabilitation group will receive a treatment protocol consisting of stretching and strengthening exercises, cold therapy, and home exercises.
    Interventions:
    • Other: Standard Rehabilitation
    • Other: Home Exercise Program
    • Other: Cold Application
Publications *
  • Méndez-Rebolledo G, Gatica-Rojas V, Torres-Cueco R, Albornoz-Verdugo M, Guzmán-Muñoz E. Update on the effects of graded motor imagery and mirror therapy on complex regional pain syndrome type 1: A systematic review. J Back Musculoskelet Rehabil. 2017;30(3):441-449. doi: 10.3233/BMR-150500. Review.
  • Sawyer EE, McDevitt AW, Louw A, Puentedura EJ, Mintken PE. Use of Pain Neuroscience Education, Tactile Discrimination, and Graded Motor Imagery in an Individual With Frozen Shoulder. J Orthop Sports Phys Ther. 2018 Mar;48(3):174-184. doi: 10.2519/jospt.2018.7716. Epub 2017 Dec 19.
  • Dilek B, Ayhan C, Yagci G, Yakut Y. Effectiveness of the graded motor imagery to improve hand function in patients with distal radius fracture: A randomized controlled trial. J Hand Ther. 2018 Jan - Mar;31(1):2-9.e1. doi: 10.1016/j.jht.2017.09.004. Epub 2017 Nov 6.
  • Priganc VW, Stralka SW. Graded motor imagery. J Hand Ther. 2011 Apr-Jun;24(2):164-8; quiz 169. doi: 10.1016/j.jht.2010.11.002. Epub 2011 Feb 9.
  • Birinci T, Razak Ozdincler A, Altun S, Kural C. A structured exercise programme combined with proprioceptive neuromuscular facilitation stretching or static stretching in posttraumatic stiffness of the elbow: a randomized controlled trial. Clin Rehabil. 2019 Feb;33(2):241-252. doi: 10.1177/0269215518802886. Epub 2018 Oct 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: February 8, 2021)
50
Original Estimated Enrollment  ICMJE
 (submitted: May 29, 2019)
42
Estimated Study Completion Date  ICMJE July 1, 2021
Actual Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects will be included with

  • Aged between 20 and 55 years
  • Elbow fracture in the six months before the study
  • Elbow limitation in flexion or extension
  • Being a volunteer to participate
  • Fractures should be managed with surgically
  • The "Standardized Mini Mental Test" result must be at least 24 points

Exclusion Criteria:

  • Malunion or Nonunion Fracture
  • The occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
  • Non-healing wound or infection
  • Previously received physiotherapy for elbow limitation
  • Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
  • Could not adjust to the treatment
  • Shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity
  • Having severe visual loss
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969277
Other Study ID Numbers  ICMJE 141001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tansu Birinci, Istanbul University-Cerrahpasa
Study Sponsor  ICMJE Istanbul University-Cerrahpasa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tansu Birinci, MSc Istanbul University-Cerrahpasa
PRS Account Istanbul University-Cerrahpasa
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP