- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04782167
Proprioception and BRACE Training in Knee Osteoarthritis
August 8, 2023 updated by: khadija liaquat
Comparison Of Brace (Balance, Resistance, Aerobic, Cognitive Exercise) And Proprioceptive Training On Balance And Mobility In Knee Osteoarthritis
Knee osteoarthritis is common joint disorder in older adults.
The prevalence of osteoarthritis is increasing in the elderly population and due to obesity.The aim of this study to compare improvement in balance between BRACE and proprioceptive training in knee osteoarthritis and to compare mobility level between proprioceptive and BRACE in knee osteoarthritis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Knee osteoarthritis is common joint disorder in older adults.
The prevalence of osteoarthritis is increasing in the elderly population and due to obesity.
Balance disorder generally disturbed equilibrium and increase risk of fall.
There is lack of proprioceptive sensation in patients with knee osteoarthritis.
The aim of this study to compare improvement in balance between BRACE and proprioceptive training in knee osteoarthritis and to compare mobility level between proprioceptive and BRACE in knee osteoarthritis.
Randomized control trial study of 8 week follows up.
Sample size will be 22.
The patients will be divided into 2 groups BRACE and proprioceptive training.
The patients will get training section for 3 days per week for 8 weeks.
The measurement will be taken at base line, after 8 weeks.
Study duration will be 6 months.
Individuals of age 50-70 year, Mini-mental state examination (MMSE) 20 or higher, Berg Balance Scale (BBS) 30-45 points, Experience of at least one fall during the previous 12 months, both Males and Females will be include.
Patients will be excluded if they exhibited history of cardiovascular or musculoskeletal diseases, previously used medication for the central nervous system, occurrence of lower limbs lesions or fractures in last six months.
Assessment tools will be MMSE, Berg balance scale, TUG, CTSIB, 6 minute walk test.
Data will be analyzed through SPSS 20.
Data will be check for its normality, within groups comparison paired sample T-test, between groups independent sample T-test will be used
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Faisalābad, Punjab, Pakistan, 38000
- Independent University Hospital, faisalabad
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 50-70 years.
- Both Males and Females
- Knee osteoarthritis unilateral and bilateral (12).
- American College of Rheumatology (ACR) criteria for diagnosing osteoarthritis of knee joint is presence of pain in knee joint plus any three of six factors listed below (13).
- Age more than 50 y
- Presence of crepitus on active motion
- Less than 30 min of morning stiffness
- Bony tenderness
- Bony overgrowth
- No palpable warmth of synovium
- Mini-mental state examination (MMSE) 23 or higher (14).
- Berg Balance Scale (BBS) 30-45 points (4)
Exclusion Criteria:
- History of stroke during the previous 12 months
History of cardiovascular or musculoskeletal diseases,
- Previously used medication for the central nervous system.
- Presence of lower limb lesions or fractures in the last six months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proprioception training
Researcher give proprioception protocol to one group
|
1st Phase - Steady phase (1st set: Eyes Open, 2nd set: Eyes Close) Preserve standup position Equally heels up and down Preserve standup on one leg by turns
|
Experimental: Brace
Researcher give BRace training to one group
|
Balance training,Static balance:
Static/Dynamic/Anti-cipatory Postural Control:
1) Count reverse from 50 Repeat with eyes open and close Reps of 30s for each 2) Push wall and reverse count from 20 3) Remember 5 words, Name 5 animals, Repeat 5 words |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg balance scale
Time Frame: 20 minutes
|
it is measure of dynamic and static balance
|
20 minutes
|
Time up and go test
Time Frame: less than 3 minutes
|
it is also measure of static and dynamic balance
|
less than 3 minutes
|
clinical test of sensory interaction on balance
Time Frame: 20 minutes
|
test for balance
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2020
Primary Completion (Actual)
November 1, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
March 1, 2021
First Submitted That Met QC Criteria
March 1, 2021
First Posted (Actual)
March 4, 2021
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah IU Ali
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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