- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05018494
Effects Of Supervised Sensorimotor Training Through Telerehabilitation Monitoring After Total Knee Arthroplasty
March 10, 2025 updated by: Riphah International University
Effects Of Supervised Sensorimotor Training With And Without Lifestyle Modifications Through Telerehabilitation Monitoring After Total Knee Arthroplasty
Knee Osteoarthritis (OA) along with low back pain, is one of the most frequent rheumatic disorder in the Asian regions.
Total Knee Arthroplasty is considered as a gold standard management strategy for relieving symptoms due to degenerative arthritis of knee.
Rehabilitation after knee arthroplasty is an essential component among this population and plays a significant role in improving the functional performance and quality of life.
However, access to rehabilitation, health care services and follow up is not always possible.
One of the possible solution is the utilization of telerehabilitation technology to allow monitoring facilities be delivered to the patients from distance, so that follow up of a patient could be ensured.
Secondly, a type of therapeutic exercise followed after knee replacement constitutes muscle strengthening, muscle stimulation with resistance exercises, sensorimotor training and telerehabilitation.
Sensorimotor training improves central nervous system function for managing movement and appropriate muscular firing patterns for maintaining joint stability.
An important component missing in the treatment regime of a knee replacement patient is the lifestyle modification program which is a combination of education, exercise and diet.
So, the aim of current project is to evaluate the effects of supervised sensorimotor training with and without lifestyle modifications through telerehabilitation monitoring on joint position sense, balance, posture, muscle strength, knee joint function and quality of life after total knee arthroplasty.
The telerehabilitation system would interaction between clinician at hospital and patients at home.
A web based portal will be developed and then utilized to provide the user with personalized information such as guided video and audio instructions about each exercise.
The digital rehabilitation solution is well established in developed nations.
It is the need of hour to introduce technological advancements in Pakistan.
Tele-rehabilitation should be incorporated as it will be helpful for the community and will reduce the dependence on human resources while ensuring better clinical outcomes as standard therapy.
Intervention group will receive lifestyle modification manual and follow up will be ensured through telerehabilitation monitoring.
Analysis will be done through SPSS 21.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
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
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Lahore Medical and Dental College
-
-
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
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Both male and female
- Successful Total Knee Arthroplasty surgery
- Ability to walk (with walking aid or unaided)
- Aged between 45 to 75 years old,
- Active knee flexion of 80 degree and active knee extension of -10 degree upon discharge
- Availability of internet service in the residing area.
Exclusion Criteria:
- Presence of health related medical conditions that could interfere with tests or the rehabilitation program
- Neurological conditions that might affect balance
- Inability to attend rehabilitation services, revised knee arthroplasty
- Blindness and any condition incompatible with 30 minutes of light to moderate physical activity
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
This group will receive the common treatment and will be discharged with complete manual on life style modifications comprising education, exercise and diet with telerehabilitation monitoring.
|
This group will receive the common treatment and will be discharged with complete manual on life style modifications comprising education, exercise and diet with telerehabilitation monitoring.
|
|
Active Comparator: Group B
This group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring.
|
This group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint position sense
Time Frame: 6 months
|
through digital photography and timings will be measured the difference between the 3 repetition will be measured.
error will be measured in seconds through photographic software.
|
6 months
|
|
Muscle thickness of Rectus femoris
Time Frame: 6 months
|
through ultrasound.
as muscle relax it will lengthen it will measured in mili meters
|
6 months
|
|
Berg balance scale
Time Frame: 6 months
|
The berg balance scale (BBS) consists of 14 items scored on a 5-point ordinal scale, ranging from 0 to 4 (0 indicates lowest level of function; 4 indicates highest level of function), with a maximum total score of 56.
Participants presenting a score of 41 to 56 points have been described as "independent"; scores of 21 to 40 are interpreted as "walking with assistance"; and scores of 0 to 20 are generally classified as "wheelchair bound."
|
6 months
|
|
knee function
Time Frame: 6 months
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered health status measure that assesses the dimensions of pain, stiffness and function The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
|
6 months
|
|
Quality of life (SF 12)
Time Frame: 6 months
|
SF 12 Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning [27].
A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rabiya Noor, PhD, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Iqbal MN, Haidri FR, Motiani B, Mannan A. Frequency of factors associated with knee osteoarthritis. J Pak Med Assoc. 2011 Aug;61(8):786-9.
- Kuether J, Moore A, Kahan J, Martucci J, Messina T, Perreault R, Sembler R, Tarutis J, Zazulak B, Rubin LE, O'Connor MI. Telerehabilitation for Total Hip and Knee Arthroplasty Patients: A Pilot Series with High Patient Satisfaction. HSS J. 2019 Oct;15(3):221-225. doi: 10.1007/s11420-019-09715-w. Epub 2019 Aug 21.
- Tousignant M, Moffet H, Boissy P, Corriveau H, Cabana F, Marquis F. A randomized controlled trial of home telerehabilitation for post-knee arthroplasty. J Telemed Telecare. 2011;17(4):195-8. doi: 10.1258/jtt.2010.100602. Epub 2011 Mar 11.
- Wadden TA, Butryn ML, Wilson C. Lifestyle modification for the management of obesity. Gastroenterology. 2007 May;132(6):2226-38. doi: 10.1053/j.gastro.2007.03.051. Erratum In: Gastroenterology. 2007 Jul;133(1):371.
- Dalle Grave R, Calugi S, Centis E, Marzocchi R, El Ghoch M, Marchesini G. Lifestyle modification in the management of the metabolic syndrome: achievements and challenges. Diabetes Metab Syndr Obes. 2010 Nov 2;3:373-85. doi: 10.2147/DMSOTT.S13860.
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 (Actual)
August 5, 2021
Primary Completion (Actual)
August 30, 2023
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
August 12, 2021
First Submitted That Met QC Criteria
August 23, 2021
First Posted (Actual)
August 24, 2021
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 10, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/2033
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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