Knee OsteoarthritisNCT04019366
Balance Training Using Biodex Stability System in Knee Osteoarthritis.
A study testing Balance Training and Conventional Training in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Balance Training and Conventional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral knee pain
- Age 35-65, Both genders
- Grade 2 or 3 on Kellgren classification for Knee Arthritis
Who cannot join
- Past history of total knee artthroplasty
- Intra articular steroid injection
- Rheumatoid Arthritis
- Use of Assistive devices e.g. canes, walkers and braces
- Knee injury
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed forces Institute of Rehabilitation Medicine (AFIRM)
Islamabad, 44000
About this study
Official title: Effects of Balance Training Using Biodex Stability System in Patients With Symptomatic 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
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Balance Training, Conventional Training
- Keywords
- Balance Training, Biodex stability system, Osteoarthrosis, Degenerative, Stability exercises
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance TrainingOther
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 TrainingOther
Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | The experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises. Receives: Other: Balance Training |
| Group II | Active comparator | The Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis. Receives: Other: Conventional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Post 4th Week
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
Measured: Baseline
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
Measured: Post 4th Week
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
Measured: Baseline
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
Measured: Post 4th Week
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
Measured: Baseline
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
Measured: Post 4th Week
Secondary outcomes (4)
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.
Measured: Baseline
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.
Measured: post 4th week
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.
Measured: Baseline
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.
Measured: Post 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start1 Feb 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment of patients into two groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huma Riaz, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019366
- Sponsor's protocol ID
- RiphahIU Samina Javed
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 15 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26542683Huang 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.
PubMed 12833248Chuang 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.
PubMed 17666307Eftekhar-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.
PubMed 26445646
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Training Using Biodex Stability System in Patients With Symptomatic Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT04019366
- Acronym / sponsor ID
- RiphahIU Samina Javed
- Conditions
- Knee Osteoarthritis
- Keywords
- Balance Training, Biodex stability system, Osteoarthrosis, Degenerative, Stability exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment of patients into two groups
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Balance TrainingThe experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises. |
| Group II | Active comparator | Other: Conventional TrainingThe Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilateral knee pain
- Age 35-65, Both genders
- Grade 2 or 3 on Kellgren classification for Knee Arthritis
Key exclusion criteria (5 listed)
- Past history of total knee artthroplasty
- Intra articular steroid injection
- Rheumatoid Arthritis
- Use of Assistive devices e.g. canes, walkers and braces
- Knee injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance TrainingExperimental 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 | Group I |
| Conventional TrainingControl group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises. | Other | Group II |
Primary outcome
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
4 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline
Numeric Pain Rating Scale (NPRS)
Time frame: post 4th week
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Post 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2019.
- Background: PubMed 26542683Baldwin 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.
- Background: PubMed 12833248Huang 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.
- Background: PubMed 17666307Chuang 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.
- Background: PubMed 26445646Eftekhar-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huma Riaz, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training and Conventional Training in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time up and Go test (TUG) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04019366, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2019.