4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Effect of mCIMT on Upper Extremity Functions of Stroke Patients With Right/Left Hemiplegia

Effect of mCIMT on Upper Extremity Functions of Stroke Patients With Right/Left Hemiplegia

Study Description
Brief Summary:
The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage. A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale.

Condition or disease Intervention/treatment Phase
Stroke Patients Other: Modified Constraint Induced Movement Therapy Not Applicable

Detailed Description:

For the rehabilitation of the paretic upper extremity, the use of constraint induced movement therapy and the use of modified constraint induced movement therapy are the most effective treatment strategies. The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage.

A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. 10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale. Wilcoxon Signed Ranks test and Friedman test were used for intragroup comparison of data and Kruskal-Wallis test was used to compare data between groups.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Functions of Stroke Patients With Right/Left Hemisphere Damage: Single Blind Randomized Controlled Trial
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : November 21, 2019
Estimated Study Completion Date : November 21, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: left hemiplegia
Patients in the left hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake
Other: Modified Constraint Induced Movement Therapy
constraint-induced movement therapy (CIMT) is characterized by the restraint of the less effected upper limb accompanied by the shaping and repetitive task-oriented training of more affected upper extremity.

Experimental: right hemiplegia
Patients in the right hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake
Other: Modified Constraint Induced Movement Therapy
constraint-induced movement therapy (CIMT) is characterized by the restraint of the less effected upper limb accompanied by the shaping and repetitive task-oriented training of more affected upper extremity.

No Intervention: control
10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme.
Outcome Measures
Primary Outcome Measures :
  1. Motor Activity Log [ Time Frame: Patients were examined at baseline ]
    Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.

  2. Motor Activity Log [ Time Frame: Patients were examined 2 weeks after baseline ]
    Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.

  3. Motor Activity Log [ Time Frame: Patients were examined 3 months after baseline ]
    Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.

  4. Fugl-Meyer Motor Assessment Scale [ Time Frame: Patients were examined at baseline ]
    The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.

  5. Fugl-Meyer Motor Assessment Scale [ Time Frame: Patients were examined 2 weeks after baseline ]
    The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.

  6. Fugl-Meyer Motor Assessment Scale [ Time Frame: Patients were examined 3 months after baseline ]
    The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.

  7. Box-Block Test [ Time Frame: Patients were examined at baseline ]
    Box-Block Test

  8. Box-Block Test [ Time Frame: Patients were examined 2 weeks after baseline ]
    Box-Block Test

  9. Box-Block Test [ Time Frame: Patients were examined 3 months after baseline ]
    Box-Block Test

  10. exercise assessment parameters-cubes lined [ Time Frame: Patients were examined at baseline ]
    cubes lined in 30 seconds

  11. exercise assessment parameters-cubes lined [ Time Frame: Patients were examined 2 weeks after baseline ]
    cubes lined in 30 seconds

  12. exercise assessment parameters-cubes lined [ Time Frame: Patients were examined 3 months after baseline ]
    cubes lined in 30 seconds

  13. exercise assessment parameters-card turned [ Time Frame: Patients were examined at baseline ]
    card turned in 30 seconds

  14. exercise assessment parameters-card turned [ Time Frame: Patients were examined 2 weeks after baseline ]
    card turned in 30 seconds

  15. exercise assessment parameters-card turned [ Time Frame: Patients were examined 3 months after baseline ]
    card turned in 30 seconds

  16. exercise assessment parameters-object gripped [ Time Frame: Patients were examined at baseline ]
    object gripped in 30 seconds

  17. exercise assessment parameters-object gripped [ Time Frame: Patients were examined 2 weeks after baseline ]
    object gripped in 30 seconds

  18. exercise assessment parameters-object gripped [ Time Frame: Patients were examined 3 months after baseline ]
    object gripped in 30 seconds

  19. exercise assessment parameters-water [ Time Frame: Patients were examined at baseline ]
    time it takes to grip and carry a water filled glass to their mouth and putting it back

  20. exercise assessment parameters-water [ Time Frame: Patients were examined 2 weeks after baseline ]
    time it takes to grip and carry a water filled glass to their mouth and putting it back

  21. exercise assessment parameters-water [ Time Frame: Patients were examined 3 months after baseline ]
    time it takes to grip and carry a water filled glass to their mouth and putting it back


Secondary Outcome Measures :
  1. Stroke Impact Scale [ Time Frame: Patients were examined at baseline ]
    Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery)

  2. Stroke Impact Scale [ Time Frame: Patients were examined 2 weeks after baseline ]
    Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery)

  3. Stroke Impact Scale [ Time Frame: Patients were examined 3 months after baseline ]
    Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients in subacute and chronic period (3 months after stroke)
  • Modified Ashworth scale in the hemiplegic arm with 3 or more spasticity
  • No pain in the hemiplegic arm
  • MMSE 20 and above
  • Without major medical problems
  • No previous stroke history
  • Adequate stability to walk when healthy arm is immobilized
  • Active 20 degrees wrist extension and 10 degrees interphalangeal and metacarpophalangeal extension (these movements should be repeated 3 times in 1 minute)

Exclusion Criteria:

  • Bilateral stroke or brainstem affected
  • Active 20-degree wrist extension and 10-degree interphalangeal and metacarpophalangeal extension
  • Global aphasia or cognitive disorders that may affect understanding of test instructions
  • Patients with major medical problems that may affect participation
  • Existence of neglect
Contacts and Locations

Contacts
Layout table for location contacts
Contact: cansın medin ceylan, asistant 531-575-9539 cansinmedin@hotmail.com
Contact: ayşe yalıman, professor 531-575-9539

Locations
Layout table for location information
Turkey
Istanbul University Istanbul Medicine Faculty Recruiting
Istanbul, Physical Medicine And Rehabilitation, Turkey
Contact: ayşe yalıman, profesor         
Sponsors and Collaborators
Istanbul University
Investigators
Layout table for investigator information
Study Director: ayşe yalıman, professor istanbul university physical medicine and rehabilitation
Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE January 2, 2018
Estimated Primary Completion Date November 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Motor Activity Log [ Time Frame: Patients were examined at baseline ]
    Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
  • Motor Activity Log [ Time Frame: Patients were examined 2 weeks after baseline ]
    Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
  • Motor Activity Log [ Time Frame: Patients were examined 3 months after baseline ]
    Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.
  • Fugl-Meyer Motor Assessment Scale [ Time Frame: Patients were examined at baseline ]
    The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.
  • Fugl-Meyer Motor Assessment Scale [ Time Frame: Patients were examined 2 weeks after baseline ]
    The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.
  • Fugl-Meyer Motor Assessment Scale [ Time Frame: Patients were examined 3 months after baseline ]
    The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity.
  • Box-Block Test [ Time Frame: Patients were examined at baseline ]
    Box-Block Test
  • Box-Block Test [ Time Frame: Patients were examined 2 weeks after baseline ]
    Box-Block Test
  • Box-Block Test [ Time Frame: Patients were examined 3 months after baseline ]
    Box-Block Test
  • exercise assessment parameters-cubes lined [ Time Frame: Patients were examined at baseline ]
    cubes lined in 30 seconds
  • exercise assessment parameters-cubes lined [ Time Frame: Patients were examined 2 weeks after baseline ]
    cubes lined in 30 seconds
  • exercise assessment parameters-cubes lined [ Time Frame: Patients were examined 3 months after baseline ]
    cubes lined in 30 seconds
  • exercise assessment parameters-card turned [ Time Frame: Patients were examined at baseline ]
    card turned in 30 seconds
  • exercise assessment parameters-card turned [ Time Frame: Patients were examined 2 weeks after baseline ]
    card turned in 30 seconds
  • exercise assessment parameters-card turned [ Time Frame: Patients were examined 3 months after baseline ]
    card turned in 30 seconds
  • exercise assessment parameters-object gripped [ Time Frame: Patients were examined at baseline ]
    object gripped in 30 seconds
  • exercise assessment parameters-object gripped [ Time Frame: Patients were examined 2 weeks after baseline ]
    object gripped in 30 seconds
  • exercise assessment parameters-object gripped [ Time Frame: Patients were examined 3 months after baseline ]
    object gripped in 30 seconds
  • exercise assessment parameters-water [ Time Frame: Patients were examined at baseline ]
    time it takes to grip and carry a water filled glass to their mouth and putting it back
  • exercise assessment parameters-water [ Time Frame: Patients were examined 2 weeks after baseline ]
    time it takes to grip and carry a water filled glass to their mouth and putting it back
  • exercise assessment parameters-water [ Time Frame: Patients were examined 3 months after baseline ]
    time it takes to grip and carry a water filled glass to their mouth and putting it back
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Stroke Impact Scale [ Time Frame: Patients were examined at baseline ]
    Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery)
  • Stroke Impact Scale [ Time Frame: Patients were examined 2 weeks after baseline ]
    Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery)
  • Stroke Impact Scale [ Time Frame: Patients were examined 3 months after baseline ]
    Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of mCIMT on Upper Extremity Functions of Stroke Patients With Right/Left Hemiplegia
Official Title  ICMJE Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Functions of Stroke Patients With Right/Left Hemisphere Damage: Single Blind Randomized Controlled Trial
Brief Summary The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage. A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale.
Detailed Description

For the rehabilitation of the paretic upper extremity, the use of constraint induced movement therapy and the use of modified constraint induced movement therapy are the most effective treatment strategies. The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage.

A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. 10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale. Wilcoxon Signed Ranks test and Friedman test were used for intragroup comparison of data and Kruskal-Wallis test was used to compare data between groups.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke Patients
Intervention  ICMJE Other: Modified Constraint Induced Movement Therapy
constraint-induced movement therapy (CIMT) is characterized by the restraint of the less effected upper limb accompanied by the shaping and repetitive task-oriented training of more affected upper extremity.
Study Arms  ICMJE
  • Experimental: left hemiplegia
    Patients in the left hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake
    Intervention: Other: Modified Constraint Induced Movement Therapy
  • Experimental: right hemiplegia
    Patients in the right hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake
    Intervention: Other: Modified Constraint Induced Movement Therapy
  • No Intervention: control
    10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme.
Publications * Yadav RK, Sharma R, Borah D, Kothari SY. Efficacy of Modified Constraint Induced Movement Therapy in the Treatment of Hemiparetic Upper Limb in Stroke Patients: A Randomized Controlled Trial. J Clin Diagn Res. 2016 Nov;10(11):YC01-YC05. doi: 10.7860/JCDR/2016/23468.8899. Epub 2016 Nov 1.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 21, 2019
Estimated Primary Completion Date November 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients in subacute and chronic period (3 months after stroke)
  • Modified Ashworth scale in the hemiplegic arm with 3 or more spasticity
  • No pain in the hemiplegic arm
  • MMSE 20 and above
  • Without major medical problems
  • No previous stroke history
  • Adequate stability to walk when healthy arm is immobilized
  • Active 20 degrees wrist extension and 10 degrees interphalangeal and metacarpophalangeal extension (these movements should be repeated 3 times in 1 minute)

Exclusion Criteria:

  • Bilateral stroke or brainstem affected
  • Active 20-degree wrist extension and 10-degree interphalangeal and metacarpophalangeal extension
  • Global aphasia or cognitive disorders that may affect understanding of test instructions
  • Patients with major medical problems that may affect participation
  • Existence of neglect
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: cansın medin ceylan, asistant 531-575-9539 cansinmedin@hotmail.com
Contact: ayşe yalıman, professor 531-575-9539
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013750
Other Study ID Numbers  ICMJE 415687
Has Data Monitoring Committee No
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
Plan to Share IPD: No
Responsible Party Cansin Medin Ceylan, Istanbul University
Study Sponsor  ICMJE Istanbul University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ayşe yalıman, professor istanbul university physical medicine and rehabilitation
PRS Account Istanbul University
Verification Date July 2019

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

治疗医院