The Feasibility And Efficacy Of A Telerehabilitation Program For People With Knee Osteoarthiritis In Sri Lanka

February 16, 2024 updated by: M.S.F.Sarjana, University of Peradeniya
it will be 8 week zoom program of exercises for knee osteo arthritis. participant will be selected according to elegibilty criteria. pre and post measurements will be obtained. then feasibility and efficacy will be assesed.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This research is to check the feasibility and efficacy of a telerehabilitation program for people with knee osteoarthritis in Sri Lanka. 14 people with knee OA will be recruited according to the inclusion and exclusion criteria. Study group will be selected with advertisement on facebook.

People who are interested will be included. Exercise booklet and instruction materials will be given to patients and initial measurement of Pain using VAS scale, 30 CST (30 second chair stand test)- Lower extremity muscle strength and dynamic balance, WOMAC (Western Ontario and McMaster Universities Arthritis Index)- pain, stiffness and physical activity will be obtained. Study group will go for 8 weeks of zoom program of exercises. Classes will be taken by the physiotherapist 3 days per week with standardized program called PEAK.knee log book will be maintained by therapist. Post 8 week same measurements on baseline will be reassessed and additional to that, Feasibility and acceptability for tele rehabilitation and Patient adherence and Safety will be assessed with attrition rate, satisfaction rate , participation to the program and measuring adverse effect respectively. Statistical Package for Social Science (SPSS) version for Windows will be used for data analysis. Pair t test will be used to compare the baseline and post 8 week results.

Study Type

Interventional

Enrollment (Estimated)

14

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

  • Sri Lanka
    • North Western
      • Puttalam, North Western, Sri Lanka, 61300
        • M.S.F.Sarjana

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Meet National Institute for Health and Care Excellence clinical criteria for OA

  • Age ≥45 years.
  • Activity-related knee joint pain.
  • Morning knee stiffness ≤ 30 min.
  • Report history of knee pain ≥ 3mths.
  • Report knee pain on most days of the past month.
  • Report an average pain score of at least 4 on an 11-point numeric rating scale during walking over the previous week.
  • Report difficulty walking and climbing stairs.
  • Have access to a device with internet connection: if they can use without assistance if possible

Exclusion Criteria:

  • On waiting list for/planning knee/hip surgery in next 12 months.
  • Previous arthroplasty on affected knee.
  • Recent knee surgery (past 6 months).
  • Consulting/ed physiotherapy or doing strengthening exercise for knee (past 6 months).
  • Self-reported inflammatory arthritis (eg rheumatoid arthritis).
  • Any neurological condition affecting lower limbs; and/or any unstable/uncontrolled cardiovascular condition.
  • Clearance to participate from a general practitioner will be required for anyone who reported a fall (past 12 months) or is house-bound due to immobility

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
single arm group exercises will be given to the patients
Other: Exercises
number of exercises will be guided to do through zoom

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of telerehabilitation program
Time Frame: post 8 weeks of exercise program
measured by attrition rate which is the measure of screened individual who are eligible but refused to participate and proportion of screened individuals who enrolled in to the study
post 8 weeks of exercise program
Feasibility and acceptability
Time Frame: post 8 week
asking patients "how satisfied they are about tele rehabilitation program" respectively at 8 weeks post.
post 8 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lower extremity muscle strength and dynamic balance
Time Frame: pre and post 8 week of exercise program
30 second chair stand test
pre and post 8 week of exercise program
pain,
Time Frame: Pre and post 8 weeks of exercise program
assessed by Visual Analogue Scale containing 0 to 10 scale
Pre and post 8 weeks of exercise program
pain stiffness and physical activity
Time Frame: pre and post 8 week of exercise program
WOMAC scale (Western Ontario and McMaster Universities Arthritis Index)
pre and post 8 week of exercise program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Peradeniya

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 (Estimated)

February 22, 2024

Primary Completion (Estimated)

April 22, 2024

Study Completion (Estimated)

May 3, 2024

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAHS

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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