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Balance Training Using Biodex Stability System in Knee Osteoarthritis.

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Balance Training
Conventional Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Balance Training, Biodex stability system, Osteoarthrosis, Degenerative, Stability exercises

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Armed forces Institute of Rehabilitation Medicine (AFIRM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I

Group II

Arm Description

The experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises.

The Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis.

Outcomes

Primary Outcome Measures

Time up and Go test (TUG)
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)
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)
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)
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)
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)
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)
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)
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

Numeric Pain Rating Scale (NPRS)
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)
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)
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)
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.

Full Information

First Posted
July 10, 2019
Last Updated
July 12, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04019366
Brief Title
Balance Training Using Biodex Stability System in Knee Osteoarthritis.
Official Title
Effects of Balance Training Using Biodex Stability System in Patients With Symptomatic Knee Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Balance Training, Biodex stability system, Osteoarthrosis, Degenerative, Stability exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment of patients into two groups
Masking
Participant
Masking Description
Patients were masked from the treatment procedure by Sealed envelope methods. Patients were randomly distributed into two groups.
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
The experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
The Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis.
Intervention Type
Other
Intervention Name(s)
Balance Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Training
Intervention Description
Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.
Primary Outcome Measure Information:
Title
Time up and Go test (TUG)
Description
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 Frame
Baseline
Title
Time up and Go test (TUG)
Description
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 Frame
Post 4th Week
Title
overall stability index (OSI)
Description
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
Time Frame
Baseline
Title
overall stability index (OSI)
Description
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
Time Frame
Post 4th Week
Title
Anterior-posterior stability index (APSI)
Description
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
Time Frame
Baseline
Title
Anterior-posterior stability index (APSI)
Description
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
Time Frame
Post 4th Week
Title
Medial-lateral stability index (MLSI)
Description
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
Time Frame
Baseline
Title
Medial-lateral stability index (MLSI)
Description
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
Time Frame
Post 4th Week
Secondary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
Baseline
Title
Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
post 4th week
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
Baseline
Title
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
Post 4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Riaz, PHD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Armed forces Institute of Rehabilitation Medicine (AFIRM)
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26542683
Citation
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.
Results Reference
background
PubMed Identifier
12833248
Citation
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. doi: 10.1053/sarh.2003.50021.
Results Reference
background
PubMed Identifier
17666307
Citation
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. doi: 10.1016/S0257-5655(07)70004-4.
Results Reference
background
PubMed Identifier
26445646
Citation
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.
Results Reference
background

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Balance Training Using Biodex Stability System in Knee Osteoarthritis.

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