- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06708884
Telerehabilitation as an Alternative to Face-to-Face Rehabilitation After Total Hip Arthroplasty
November 26, 2024 updated by: Akın Süzer, Burdur Mehmet Akif Ersoy University
Is Telerehabilitation a Good Alternative to Face-to-Face Rehabilitation Beyond Clinical Walls in Recovery After Total Hip Arthroplasty
The goal of this clinical trial is to learn if telerehabilitation in patients who had undergone total hip arthroplasty. The main questions it aims to answer are:
- Does telerehabilitation improve the functional level of the participants?
- Does telerehabilitation improve the locomotor performance of the participants? Researchers will compare telerehabilitation to face to face rehabilitation (traditional rehabilitation programme) to see if telerehabilitation works in total hip arthroplasty recovery.
Participants will:
- Attend physiotherapy and rehabilitation sessions supervised by a physiotherapist 2 days a week for 8 weeks.
- Participate in assessments (before surgery and at 6 weeks and 12 weeks after surgery).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
36
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 Contact
- Name: Akın Süzer, PT, PhD
- Phone Number: 05554843024
- Email: akinsuzer@gmail.com
Study Locations
-
-
-
Burdur, Turkey, 15100
- Burdur Mehmet Akif Ersoy University
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having hip arthroplasty surgery
- To be able to understand verbal and written information
- No cognitive impairment
- To be able to speak and understand Turkish
Exclusion Criteria:
- Having a neurological disease
- Having a psychiatric disorder
- Visual or hearing loss that cannot be corrected with any assistive device
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 1: TR Group
TR: telerehabilitation.
During the follow-up period, a standard exercise programme will be applied to the TR group via videoconference-based telerehabilitation.
|
exercise programme will be implemented via telerehabilitation
exercise programme will be implemented via face-to-face
|
|
Experimental: Group 1: F2F Group
F2F: face to face.
During the follow-up period, a standard exercise programme will be applied to the F2F group via face to face rehabilitation.
|
exercise programme will be implemented via telerehabilitation
exercise programme will be implemented via face-to-face
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional level
Time Frame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
Functional level was assessed using the Western Ontario McMaster University Osteoarthritis Index.
Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions and 3 subcategories (pain, stiffness and physical function).
Pain is evaluated with 5 questions, stiffness with 2 questions and physical function with 17 questions.
Each question in the Index is scored from 0 (none) to 4 (very severe, very difficult).
The total score can be a minimum of 0 and a maximum of 100.
In addition, each subcategory can also be evaluated on its own.
A higher score on the Index indicates more symptoms and physical disability.
|
Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
Pain intensity was assessed using the pain subcategory of Western Ontario McMaster University Osteoarthritis Index and the Visual Analog Scale.
There are 5 questions in the pain subcategory of the Western Ontario and McMaster Universities Osteoarthritis Index.
Each question in the Index is scored from 0 (none) to 4 (very severe, very difficult).
The pain score can be a minimum of 0 and a maximum of 20.
A higher pain score indicates more pain.
Visual Analog Scale consists of a horizontal 10 cm straight line.
When viewed from left to right, there is a value of 0 at the beginning and 10 at the end of the line.
The 0 point of the line indicates no pain and the 10 point indicates the most severe pain felt in life.
|
Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
|
Quality of life
Time Frame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
Quality of life will be assessed with the EQ-5D General Quality of Life Questionnaire.
The first part of the questionnaire consists of questions related to five different areas of health, including mobility, personal care, usual activities, pain/discomfort, and anxiety/depression.
Each question is rated on a three-point scale as 'no problem, some problem and major problem'.
Therefore, the questionnaire generates 243 different results.
As a result of the scoring, a score between -0.59 and 1 is obtained and 0 indicates death, 1 indicates full health, minus values indicate unconsciousness, etc.
The second part of the questionnaire shows the score that the person gives to the health status by marking on a vertical ruler or a thermometer-like visual analogue scale between 0 and 100.
A score of 100 indicates the healthiest state.
|
Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
|
Locomotor performance
Time Frame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
Locomotor performance was assessed with the stair climb test.
Stair Climb Test: The time taken to ascend and then descend a 9-step staircase was recorded as the patient's score.
|
Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
|
Lower extremity muscle strength
Time Frame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
Lower extremity muscle strength will be assessed with the a hand dynamometer.
Hand Dynamometer: Hip muscles (flexors, extensors, abductors and adductors) and knee extensors will be evaluated using a hand dynamometer (Commander Muscle Tester, JTech, USA). 3 consecutive maximum isometric contraction measurements at 1 minute intervals will be averaged.
|
Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
|
Hip Joint Range of Motion (ROM)
Time Frame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
Range of Motion (ROM) will be evaluated by goniometric measurement.
|
Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 (Estimated)
December 15, 2024
Primary Completion (Estimated)
March 15, 2025
Study Completion (Estimated)
April 15, 2025
Study Registration Dates
First Submitted
November 22, 2024
First Submitted That Met QC Criteria
November 26, 2024
First Posted (Estimated)
November 27, 2024
Study Record Updates
Last Update Posted (Estimated)
November 27, 2024
Last Update Submitted That Met QC Criteria
November 26, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ErsoyU.22112024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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