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

Primary Purpose

Arthropathy of Knee

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
experimental treatment
common treatment
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthropathy of Knee

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lahore Medical and Dental CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

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 home exercise plan without telerehabilitation monitoring.

Outcomes

Primary Outcome Measures

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.
Muscle thickness of Rectus femoris
through ultrasound. as muscle relax it will lengthen it will measured in mili meters
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."
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.
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

Secondary Outcome Measures

Full Information

First Posted
August 12, 2021
Last Updated
December 7, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05018494
Brief Title
Effects Of Supervised Sensorimotor Training Through Telerehabilitation Monitoring After Total Knee Arthroplasty
Official Title
Effects Of Supervised Sensorimotor Training With And Without Lifestyle Modifications Through Telerehabilitation Monitoring After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
This group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring.
Intervention Type
Other
Intervention Name(s)
experimental treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
common treatment
Intervention Description
This group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring.
Primary Outcome Measure Information:
Title
Joint position sense
Description
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.
Time Frame
6 months
Title
Muscle thickness of Rectus femoris
Description
through ultrasound. as muscle relax it will lengthen it will measured in mili meters
Time Frame
6 months
Title
Berg balance scale
Description
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."
Time Frame
6 months
Title
knee function
Description
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.
Time Frame
6 months
Title
Quality of life (SF 12)
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Rabiya Noor, PhD
Phone
03344355660
Email
rabiya.noor@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabiya noor, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahore Medical and Dental College
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiz Asim, Ms

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22356003
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.
Results Reference
background
PubMed Identifier
31624476
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.
Results Reference
background
PubMed Identifier
21398389
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.
Results Reference
background
PubMed Identifier
17498514
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.
Results Reference
background
PubMed Identifier
21437107
Citation
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.
Results Reference
background

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

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