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出境医 / 临床实验 / Balance Training Using Biodex Stability System in Knee Osteoarthritis.

Balance Training Using Biodex Stability System in Knee Osteoarthritis.

Study Description
Brief Summary:
This was a randomized control Trial, conducted with two group of patients, one has received Balance and stability training on Biodex stability system along with conservative protocol of traditional exercises. the other group has received only conservative protocol of traditional exercises

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Balance Training Other: Conventional Training Not Applicable

Detailed Description:

Patients with Symptomatic Knee Osteoarthritis have balance and stability deficits. In routine such patients are not evaluated and treated on balance and stability parameters. So this study was conducted with objectives to determine the effects of Balance training using Biodex stability system in patients with symptomatic knee osteoarthritis.

Experimental group has received Balance and stability training on Biodex stability system along with conservative protocol of traditional exercises.

Control group has received only conservative protocol of traditional exercises.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment of patients into two groups
Masking: Single (Participant)
Masking Description: Patients were masked from the treatment procedure by Sealed envelope methods. Patients were randomly distributed into two groups.
Primary Purpose: Treatment
Official Title: Effects of Balance Training Using Biodex Stability System in Patients With Symptomatic Knee Osteoarthritis.
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018
Arms and Interventions
Arm Intervention/treatment
Experimental: Group I
The experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises.
Other: Balance Training
Experimental group received balance training on Biodex stability System along with traditional exercise program. During balance training on Biodex, patients were instructed to stand on the platform with bare feet with open eyes and both legs supported. Patients were looking forward to screen having hands hang by the sides. The patients were instructed not to change their feet position and balance the body. The handles were accessible for safety point. But touching the handles cancelled the trail. Total time of training was 10 minutes each set is of 3 minutes with 20 sec rest intervals.

Active Comparator: Group II
The Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis.
Other: Conventional Training
Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.

Outcome Measures
Primary Outcome Measures :
  1. Time up and Go test (TUG) [ Time Frame: Baseline ]
    Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG.

  2. Time up and Go test (TUG) [ Time Frame: Post 4th Week ]
    Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG.

  3. overall stability index (OSI) [ Time Frame: Baseline ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94

  4. overall stability index (OSI) [ Time Frame: Post 4th Week ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94

  5. Anterior-posterior stability index (APSI) [ Time Frame: Baseline ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95

  6. Anterior-posterior stability index (APSI) [ Time Frame: Post 4th Week ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95

  7. Medial-lateral stability index (MLSI) [ Time Frame: Baseline ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93

  8. Medial-lateral stability index (MLSI) [ Time Frame: Post 4th Week ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93


Secondary Outcome Measures :
  1. Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline ]
    Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.

  2. Numeric Pain Rating Scale (NPRS) [ Time Frame: post 4th week ]
    Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.

  3. Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Baseline ]
    It is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items):Stiffness (2 items): Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

  4. Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Post 4th week ]
    It is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items):Stiffness (2 items): Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bilateral knee pain
  • Age 35-65, Both genders
  • Grade 2 or 3 on Kellgren classification for Knee Arthritis

Exclusion Criteria:

  • Past history of total knee artthroplasty
  • Intra articular steroid injection
  • Rheumatoid Arthritis
  • Use of Assistive devices e.g. canes, walkers and braces
  • Knee injury
Contacts and Locations

Locations
Layout table for location information
Pakistan
Armed forces Institute of Rehabilitation Medicine (AFIRM)
Islamabad, Pakistan, 44000
Sponsors and Collaborators
Riphah International University
Investigators
Layout table for investigator information
Principal Investigator: Huma Riaz, PHD* Riphah International University
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 15, 2019
Last Update Posted Date July 15, 2019
Actual Study Start Date  ICMJE February 1, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Time up and Go test (TUG) [ Time Frame: Baseline ]
    Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG.
  • Time up and Go test (TUG) [ Time Frame: Post 4th Week ]
    Patients were asked to perform test at usual walking speed. Initial testing standardized verbal instructions given to the participant regarding procedure. For performing TUG participants were instructed to walk three meter and then, walk back to sit down. Note time on stopwatch. The average of tests trail was measured as the mean of TUG.
  • overall stability index (OSI) [ Time Frame: Baseline ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94
  • overall stability index (OSI) [ Time Frame: Post 4th Week ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .94
  • Anterior-posterior stability index (APSI) [ Time Frame: Baseline ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95
  • Anterior-posterior stability index (APSI) [ Time Frame: Post 4th Week ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .95
  • Medial-lateral stability index (MLSI) [ Time Frame: Baseline ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93
  • Medial-lateral stability index (MLSI) [ Time Frame: Post 4th Week ]
    Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System.Its reliability is R = .93
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: Baseline ]
    Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
  • Numeric Pain Rating Scale (NPRS) [ Time Frame: post 4th week ]
    Numeric Pain Rating Scale (NPRS) is used to assess pain. It scores ranges from 0-10, 0 means No pain and 10 means Severe pain. Patient will be asked to verbally report the pain score.
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Baseline ]
    It is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items):Stiffness (2 items): Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Post 4th week ]
    It is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items):Stiffness (2 items): Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
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 Balance Training Using Biodex Stability System in Knee Osteoarthritis.
Official Title  ICMJE Effects of Balance Training Using Biodex Stability System in Patients With Symptomatic Knee Osteoarthritis.
Brief Summary This was a randomized control Trial, conducted with two group of patients, one has received Balance and stability training on Biodex stability system along with conservative protocol of traditional exercises. the other group has received only conservative protocol of traditional exercises
Detailed Description

Patients with Symptomatic Knee Osteoarthritis have balance and stability deficits. In routine such patients are not evaluated and treated on balance and stability parameters. So this study was conducted with objectives to determine the effects of Balance training using Biodex stability system in patients with symptomatic knee osteoarthritis.

Experimental group has received Balance and stability training on Biodex stability system along with conservative protocol of traditional exercises.

Control group has received only conservative protocol of traditional exercises.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment of patients into two groups
Masking: Single (Participant)
Masking Description:
Patients were masked from the treatment procedure by Sealed envelope methods. Patients were randomly distributed into two groups.
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Other: Balance Training
    Experimental group received balance training on Biodex stability System along with traditional exercise program. During balance training on Biodex, patients were instructed to stand on the platform with bare feet with open eyes and both legs supported. Patients were looking forward to screen having hands hang by the sides. The patients were instructed not to change their feet position and balance the body. The handles were accessible for safety point. But touching the handles cancelled the trail. Total time of training was 10 minutes each set is of 3 minutes with 20 sec rest intervals.
  • Other: Conventional Training
    Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.
Study Arms  ICMJE
  • Experimental: Group I
    The experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises.
    Intervention: Other: Balance Training
  • Active Comparator: Group II
    The Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis.
    Intervention: Other: Conventional Training
Publications *
  • Baldwin SL, Das JP. Atmospheric Ar and Ne returned from mantle depths to the Earth's surface by forearc recycling. Proc Natl Acad Sci U S A. 2015 Nov 17;112(46):14174-9. doi: 10.1073/pnas.1424122112. Epub 2015 Nov 5.
  • Huang MH, Lin YS, Yang RC, Lee CL. A comparison of various therapeutic exercises on the functional status of patients with knee osteoarthritis. Semin Arthritis Rheum. 2003 Jun;32(6):398-406.
  • Chuang SH, Huang MH, Chen TW, Weng MC, Liu CW, Chen CH. Effect of knee sleeve on static and dynamic balance in patients with knee osteoarthritis. Kaohsiung J Med Sci. 2007 Aug;23(8):405-11.
  • Eftekhar-Sadat B, Azizi R, Aliasgharzadeh A, Toopchizadeh V, Ghojazadeh M. Effect of balance training with Biodex Stability System on balance in diabetic neuropathy. Ther Adv Endocrinol Metab. 2015 Oct;6(5):233-40. doi: 10.1177/2042018815595566.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2019)
43
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 30, 2018
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Bilateral knee pain
  • Age 35-65, Both genders
  • Grade 2 or 3 on Kellgren classification for Knee Arthritis

Exclusion Criteria:

  • Past history of total knee artthroplasty
  • Intra articular steroid injection
  • Rheumatoid Arthritis
  • Use of Assistive devices e.g. canes, walkers and braces
  • Knee injury
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04019366
Other Study ID Numbers  ICMJE RiphahIU Samina Javed
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 Riphah International University
Study Sponsor  ICMJE Riphah International University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Huma Riaz, PHD* Riphah International University
PRS Account Riphah International University
Verification Date July 2019

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