Effects Of Supervised Sensorimotor Training Through Telerehabilitation Monitoring After Total Knee Arthroplasty

Arthropathy of Knee Clinical Trial

Official title:

Effects Of Supervised Sensorimotor Training With And Without Lifestyle Modifications Through Telerehabilitation Monitoring After Total Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05018494
• Other study ID #: REC/Lhr/2033
• Status: Recruiting
• Phase: N/A
• Start date: August 5, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: December 2022
• Source: Riphah International University
• Contact: Dr. Rabiya Noor, PhD
• Phone: 03344355660
• Email: rabiya.noor[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: October 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Both male and female

2. Successful Total Knee Arthroplasty surgery

3. Ability to walk (with walking aid or unaided)

4. Aged between 45 to 75 years old,

5. Active knee flexion of 80 degree and active knee extension of -10 degree upon discharge

6. Availability of internet service in the residing area.

Exclusion Criteria:

1. Presence of health related medical conditions that could interfere with tests or the rehabilitation program

2. Neurological conditions that might affect balance

3. Inability to attend rehabilitation services, revised knee arthroplasty

4. Blindness and any condition incompatible with 30 minutes of light to moderate physical activity

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases

Intervention

Other:
• experimental treatment
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.
• common treatment
This group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring.

Locations

Country	Name	City	State
Pakistan	Lahore Medical and Dental College	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint position sense	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
Primary	Muscle thickness of Rectus femoris	through ultrasound. as muscle relax it will lengthen it will measured in mili meters	6 months
Primary	Berg balance scale	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
Primary	knee function	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
Primary	Quality of life (SF 12)	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