Condition or disease | Intervention/treatment | Phase |
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Knee Osteoarthritis | Other: Balance Training Other: Conventional Training | Not Applicable |
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 : | 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 |
Arm | Intervention/treatment |
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Experimental: Group I
The experimental group was treated with Balance Training on Biodex Stability System along with traditional exercises.
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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.
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Active Comparator: Group II
The Control group was treated with Traditional exercises only for Symptomatic knee osteoarthritis.
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Other: Conventional Training
Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.
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Ages Eligible for Study: | 35 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pakistan | |
Armed forces Institute of Rehabilitation Medicine (AFIRM) | |
Islamabad, Pakistan, 44000 |
Principal Investigator: | Huma Riaz, PHD* | Riphah International University |
Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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
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Condition ICMJE | Knee Osteoarthritis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Riphah International University | ||||
Study Sponsor ICMJE | Riphah International University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |