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Completed

NCT Number: NCT04019366

Balance Training Using Biodex Stability System in Knee Osteoarthritis.

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

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armed forces Institute of Rehabilitation Medicine (AFIRM)

Islamabad, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balance training

Other

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.

Conventional training

Other

Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Balance Training Using Biodex Stability System in Patients With Symptomatic Knee Osteoarthritis.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 15, 2019
Registry last updated
Jul 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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