NCT04782167

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

5 months

First QC Date

March 1, 2021

Last Update Submit

August 8, 2023

Conditions

Keywords

proprioception training, balance, BBS,

Outcome Measures

Primary Outcomes (3)

  • Berg balance scale

    it is measure of dynamic and static balance

    20 minutes

  • Time up and go test

    it is also measure of static and dynamic balance

    less than 3 minutes

  • clinical test of sensory interaction on balance

    test for balance

    20 minutes

Study Arms (2)

Proprioception training

EXPERIMENTAL

Researcher give proprioception protocol to one group

Behavioral: Propirioceptive training

Brace

EXPERIMENTAL

Researcher give BRace training to one group

Behavioral: BRACE

Interventions

BRACEBEHAVIORAL

Balance 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

Brace

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

Proprioception training

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Independent University Hospital, faisalabad

Faisalābad, Punjab Province, 38000, Pakistan

Location

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

June 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

August 14, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations