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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06268925
• Other study ID #: UAHS
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 22, 2024
• Est. completion date: May 3, 2024

Study information

• Verified date: February 2024
• Source: University of Peradeniya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 14
• Est. completion date: May 3, 2024
• Est. primary completion date: April 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Exercises
number of exercises will be guided to do through zoom

Locations

Country	Name	City	State
Sri Lanka	M.S.F.Sarjana	Puttalam	North Western

Sponsors (1)

Lead Sponsor	Collaborator
University of Peradeniya

Country where clinical trial is conducted

Sri Lanka, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of telerehabilitation 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
Primary	Feasibility and acceptability	asking patients "how satisfied they are about tele rehabilitation program" respectively at 8 weeks post.	post 8 week
Secondary	lower extremity muscle strength and dynamic balance	30 second chair stand test	pre and post 8 week of exercise program
Secondary	pain,	assessed by Visual Analogue Scale containing 0 to 10 scale	Pre and post 8 weeks of exercise program
Secondary	pain stiffness and physical activity	WOMAC scale (Western Ontario and McMaster Universities Arthritis Index)	pre and post 8 week of exercise program