Osteoarthritis Knees BothNCT04782167
Proprioception and BRACE Training in Knee Osteoarthritis
A study testing BRACE and Propirioceptive training in people with Osteoarthritis Knees Both, run by khadija liaquat at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Osteoarthritis Knees Both
- What is being tested?
- BRACE and Propirioceptive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2020to 1 Nov 2020
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Independent University Hospital, faisalabad
Faisalābad, Punjab Province, 38000
About this study
Official title: 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
Read the 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
- Conditions
- Osteoarthritis Knees Both
- Being tested
- BRACE, Propirioceptive training
- Keywords
- proprioception training, balance, BBS,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRACEBehavioural
Balance training,Static balance:
- Romberg with eye open \& eye close [30 sec repeat 3 times]
- Tandem standing with eye open then with eye close. Right foot front first, then left foot front [10 Sec repeat 3 times]
- Single leg stance 5 repetition with sec.
Static/Dynamic/Anti-cipatory Postural Control:
- Sit to stand: 5 repetition
- Functional reach test: forward, sideways \& cross reach, practice 1 min for each
- TUG test: with distance of 10 feet \& time 10 sec. practice 2 min Cognitive exercises
- 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
Propirioceptive trainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Proprioception training | Experimental | Researcher give proprioception protocol to one group Receives: Behavioral: Propirioceptive training |
| Brace | Experimental | Researcher give BRace training to one group Receives: Behavioral: BRACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg balance scale
it is measure of dynamic and static balance
Measured: 20 minutes
Time up and go test
it is also measure of static and dynamic balance
Measured: less than 3 minutes
clinical test of sensory interaction on balance
test for balance
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jun 2020
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis Knees BothStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- khadija liaquat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, khadija liaquat, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782167
- Sponsor's protocol ID
- Riphah IU Ali
- Status last verified
- Aug 2023
- First submitted
- 1 Mar 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Brace (Balance, Resistance, Aerobic, Cognitive Exercise) And Proprioceptive Training On Balance And Mobility In Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04782167
- Acronym / sponsor ID
- Riphah IU Ali
- Conditions
- Osteoarthritis Knees Both
- Keywords
- proprioception training, balance, BBS,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- khadija liaquatUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 4 Mar 2021 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioception training | Experimental | Behavioral: Propirioceptive trainingResearcher give proprioception protocol to one group |
| Brace | Experimental | Behavioral: BRACEResearcher give BRace training to one group |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- History of stroke during the previous 12 months
- History of cardiovascular or musculoskeletal diseases,
- Presence of lower limb lesions or fractures in the last six months
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 |
|---|---|---|
| BRACEBalance training,Static balance: 1. Romberg with eye open \& eye close [30 sec repeat 3 times] 2. Tandem standing with eye open then with eye close. Right foot front first, then left foot front [10 Sec repeat 3 times] 3. Single leg stance 5 repetition with sec. Static/Dynamic/Anti-cipatory Postural Control: 1. Sit to stand: 5 repetition 2. Functional reach test: forward, sideways \& cross reach, practice 1 min for each 3. TUG test: with distance of 10 feet \& time 10 sec. practice 2 min Cognitive exercises 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 | Behavioural | Brace |
| Propirioceptive training1st 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 | Behavioural | Proprioception training |
Primary outcome
Berg balance scale
Time frame: 20 minutes
it is measure of dynamic and static balance
Time up and go test
Time frame: less than 3 minutes
it is also measure of static and dynamic balance
clinical test of sensory interaction on balance
Time frame: 20 minutes
test for balance
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 14 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRACE and Propirioceptive training in people with Osteoarthritis Knees Both, run by khadija liaquat 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 12 inclusion and 4 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 14 Aug 2023. 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?
Berg balance scale (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2023.