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Proprioception and BRACE Training in Knee Osteoarthritis

Primary Purpose

Osteoarthritis Knees Both

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
BRACE
Propirioceptive training
Sponsored by
khadija liaquat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Knees Both focused on measuring proprioception training, balance, BBS,

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 50-70 years. 2. Both Males and Females 3. Knee osteoarthritis unilateral and bilateral (12). 4. 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 5. Mini-mental state examination (MMSE) 23 or higher (14). 6. Berg Balance Scale (BBS) 30-45 points (4)

Exclusion Criteria:

  • History of stroke during the previous 12 months 2. History of cardiovascular or musculoskeletal diseases, 3. Previously used medication for the central nervous system. 4. Presence of lower limb lesions or fractures in the last six months

Sites / Locations

  • Independent University Hospital, faisalabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Proprioception training

Brace

Arm Description

Researcher give proprioception protocol to one group

Researcher give BRace training to one group

Outcomes

Primary Outcome Measures

Berg balance scale
it is measure of dynamic and static balance
Time up and go test
it is also measure of static and dynamic balance
clinical test of sensory interaction on balance
test for balance

Secondary Outcome Measures

Full Information

First Posted
March 1, 2021
Last Updated
August 8, 2023
Sponsor
khadija liaquat
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1. Study Identification

Unique Protocol Identification Number
NCT04782167
Brief Title
Proprioception and BRACE Training in Knee Osteoarthritis
Official Title
Comparison Of Brace (Balance, Resistance, Aerobic, Cognitive Exercise) And Proprioceptive Training On Balance And Mobility In Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
khadija liaquat

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Knees Both
Keywords
proprioception training, balance, BBS,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Proprioception training
Arm Type
Experimental
Arm Description
Researcher give proprioception protocol to one group
Arm Title
Brace
Arm Type
Experimental
Arm Description
Researcher give BRace training to one group
Intervention Type
Behavioral
Intervention Name(s)
BRACE
Intervention Description
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 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
Intervention Type
Behavioral
Intervention Name(s)
Propirioceptive training
Intervention Description
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
Primary Outcome Measure Information:
Title
Berg balance scale
Description
it is measure of dynamic and static balance
Time Frame
20 minutes
Title
Time up and go test
Description
it is also measure of static and dynamic balance
Time Frame
less than 3 minutes
Title
clinical test of sensory interaction on balance
Description
test for balance
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Independent University Hospital, faisalabad
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Proprioception and BRACE Training in Knee Osteoarthritis

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