Knee InjuriesNCT06457620
Comparison of Telerehabilitation vs Clinical Setup Rehabilitation in TKR Patients
A study testing Conventional Physiotherapy and Traditional Physical Preatment in people with Knee Injuries, run by Superior University at 1 site in Pakistan.
Trial summary
This study examines the feasibility, attainability, and patient satisfaction of telerehabilitation and clinical consultation rehabilitation. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Conventional Physiotherapy and Traditional Physical Preatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Oct 2024
- 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male and female patients diagnosed with TKR
- Older Age above 65
- Patient communicates with medical staff
- Patient with cemented TKA
- Patients who underwent TKA owing to degenerative arthritis
Who cannot join
- Older patients aged >75 years
- Patient with a history of knee joint surgery before TKA
- Patient who possibly had a systematic inflammatory disease such as rheumatoid arthritis.
- Patients with difficulty in seeing, hearing, and walking independently
- Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease)
- Patient history of severe mobility disorder
- Systemic illness (Liver Failure, Active cancer, Cardiopulmonary distress)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Acti Life Physiotherapy and Rehabilitation Center Horizon Hospital
Lahore, Punjab Province
About this study
This study examines the feasibility, attainability, and patient satisfaction of telerehabilitation and clinical consultation rehabilitation.
Read the detailed description
The objective is to assess whether telerehabilitation can provide comparable or significantly better outcomes in terms of functional recovery, pain management, improved range of motion, and patient satisfaction for Total Knee Replacement (TKR) patients. If telehealth interventions prove successful, they can be implemented to increase access to high-quality rehabilitation treatments and enhance healthcare delivery. Evidence-based findings from this study can help healthcare providers make educated decisions about incorporating telerehabilitation into post-operative rehabilitation protocols, thereby enhancing patient care and optimizing resource utilization in orthopedic settings.
- Conditions
- Knee Injuries
- Being tested
- Conventional Physiotherapy, Traditional Physical Preatment
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyBehavioural
Each participant received conventional physiotherapy at the clinic as a part of their management plan. Group A exercise was five times a week for thirty minutes, beginning on the third day after total knee arthroplasty (TKA). The program aimed to improve leg strength, core stability, balance, and overall performance through exercise instructions. The baseline evaluation was completed one day before the TKA, and the posttest was completed four weeks after the TKA.
Traditional Physical PreatmentOther
Each participant got traditional physical treatment during a video conference as part of telerehabilitation. The physiotherapy assistant contacted Group B to arrange a virtual follow-up clinic appointment via Zoom or WhatsApp, along with a 4-week program. We inquired about the patient's level of satisfaction with their TKR procedure. The patient was informed that clinical photos were taken, and the video call was to be recorded. Before the virtual clinic, each patient's verbal agreement was acquired. With workout instructions, the program pursued to enhance leg strength, core stability, balance, and overall performance. The posttest was conducted four weeks after the TKA, and the baseline assessment was finished one day before the procedure.
| Study group | Role | What they receive |
|---|---|---|
| conventional physiotherapy | Experimental | Not described Receives: Behavioral: Conventional Physiotherapy |
| traditional physical treatment | Other | Not described Receives: Other: Traditional Physical Preatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis (WoMAC)
The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. ,
Measured: 12 Months
Knee Outcome Survey-Activities of Daily Living (KOS-ADLS)
The Knee Outcome Survey (KOS) is a patient-completed questionnaire that provides a percentage of disability during every day activities (activities of daily living subscale) or sports (sports activity subscale). The lower the percentage, the higher the disability.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457620
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/725
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Telerehabilitation vs Clinical Setup Rehabilitation in TKR Patients
- ClinicalTrials.gov ID
- NCT06457620
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/725
- Conditions
- Knee Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 13 Jun 2024 (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.
This study examines the feasibility, attainability, and patient satisfaction of telerehabilitation and clinical consultation rehabilitation.
Detailed description
The objective is to assess whether telerehabilitation can provide comparable or significantly better outcomes in terms of functional recovery, pain management, improved range of motion, and patient satisfaction for Total Knee Replacement (TKR) patients. If telehealth interventions prove successful, they can be implemented to increase access to high-quality rehabilitation treatments and enhance healthcare delivery. Evidence-based findings from this study can help healthcare providers make educated decisions about incorporating telerehabilitation into post-operative rehabilitation protocols, thereby enhancing patient care and optimizing resource utilization in orthopedic settings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional physiotherapy | Experimental | Behavioral: Conventional Physiotherapy |
| traditional physical treatment | Other | Other: Traditional Physical Preatment |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male and female patients diagnosed with TKR
- Older Age above 65
- Patient communicates with medical staff
- Patient with cemented TKA
- Patients who underwent TKA owing to degenerative arthritis
Key exclusion criteria (7 listed)
- Older patients aged >75 years
- Patient with a history of knee joint surgery before TKA
- Patient who possibly had a systematic inflammatory disease such as rheumatoid arthritis.
- Patients with difficulty in seeing, hearing, and walking independently
- Patients having a history of mental illnesses (Stroke, Multiple sclerosis, Parkinsonism, Alzheimer's Disease)
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 |
|---|---|---|
| Conventional PhysiotherapyEach participant received conventional physiotherapy at the clinic as a part of their management plan. Group A exercise was five times a week for thirty minutes, beginning on the third day after total knee arthroplasty (TKA). The program aimed to improve leg strength, core stability, balance, and overall performance through exercise instructions. The baseline evaluation was completed one day before the TKA, and the posttest was completed four weeks after the TKA. | Behavioural | conventional physiotherapy |
| Traditional Physical PreatmentEach participant got traditional physical treatment during a video conference as part of telerehabilitation. The physiotherapy assistant contacted Group B to arrange a virtual follow-up clinic appointment via Zoom or WhatsApp, along with a 4-week program. We inquired about the patient's level of satisfaction with their TKR procedure. The patient was informed that clinical photos were taken, and the video call was to be recorded. Before the virtual clinic, each patient's verbal agreement was acquired. With workout instructions, the program pursued to enhance leg strength, core stability, balance, and overall performance. The posttest was conducted four weeks after the TKA, and the baseline assessment was finished one day before the procedure. | Other | traditional physical treatment |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis (WoMAC)
Time frame: 12 Months
The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. ,
Knee Outcome Survey-Activities of Daily Living (KOS-ADLS)
Time frame: 12 months
The Knee Outcome Survey (KOS) is a patient-completed questionnaire that provides a percentage of disability during every day activities (activities of daily living subscale) or sports (sports activity subscale). The lower the percentage, the higher the disability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy and Traditional Physical Preatment in people with Knee Injuries, run by Superior 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. 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?
Results are not available in the source record.
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?
Western Ontario and McMaster Universities Osteoarthritis (WoMAC) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2024.