Arthropathy of KneeNCT05018494
Effects Of Supervised Sensorimotor Training Through Telerehabilitation Monitoring After Total Knee Arthroplasty
A study testing experimental treatment and common treatment in people with Arthropathy of Knee, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Arthropathy of Knee
- What is being tested?
- experimental treatment and common treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2021to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore Medical and Dental College
Lahore, Punjab Province, 54000
About this study
Official title: 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.
- Conditions
- Arthropathy of Knee
- Being tested
- experimental treatment, common treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental treatmentOther
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 treatmentOther
This group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Other: experimental treatment |
| Group B | Active comparator | This group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring. Receives: Other: common treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Muscle thickness of Rectus femoris
through ultrasound. as muscle relax it will lengthen it will measured in mili meters
Measured: 6 months
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."
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start5 Aug 2021
- Primary completion30 Aug 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of KneeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya noor, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018494
- Sponsor's protocol ID
- REC/Lhr/2033
- Status last verified
- Mar 2025
- First submitted
- 12 Aug 2021
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22356003Kuether 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.
PubMed 31624476Tousignant 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.
PubMed 21398389Wadden 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.
PubMed 17498514Dalle 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.
PubMed 21437107Sadiq S, Noor R, Akram R. Effect of Lifestyle Modification Through Web-Based Telerehabilitation Monitoring Combined With Supervised Sensorimotor Training After Total Knee Arthroplasty: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Oct 2;13:e64643. doi: 10.2196/64643.
PubMed 41037782
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Supervised Sensorimotor Training With And Without Lifestyle Modifications Through Telerehabilitation Monitoring After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05018494
- Acronym / sponsor ID
- REC/Lhr/2033
- Conditions
- Arthropathy of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: experimental treatmentThis 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. |
| Group B | Active comparator | Other: common treatmentThis group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental treatmentThis 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. | Other | Group A |
| common treatmentThis group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring. | Other | Group B |
Primary outcome
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.
Muscle thickness of Rectus femoris
Time frame: 6 months
through ultrasound. as muscle relax it will lengthen it will measured in mili meters
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."
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 22356003Iqbal MN, Haidri FR, Motiani B, Mannan A. Frequency of factors associated with knee osteoarthritis. J Pak Med Assoc. 2011 Aug;61(8):786-9.
- Background: PubMed 31624476Kuether 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.
- Background: PubMed 21398389Tousignant 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.
- Background: PubMed 17498514Wadden 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.
- Background: PubMed 21437107Dalle 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.
- Derived from this study: PubMed 41037782Sadiq S, Noor R, Akram R. Effect of Lifestyle Modification Through Web-Based Telerehabilitation Monitoring Combined With Supervised Sensorimotor Training After Total Knee Arthroplasty: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Oct 2;13:e64643. doi: 10.2196/64643.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabiya noor, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental treatment and common treatment in people with Arthropathy of Knee, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint position sense (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05018494, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.