Total Hip Arthroplasty (THA)NCT06708884
Telerehabilitation as an Alternative to Face-to-Face Rehabilitation After Total Hip Arthroplasty
A study testing Exercise in people with Total Hip Arthroplasty (THA), run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
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?… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Hip Arthroplasty (THA)
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having hip arthroplasty surgery
- To be able to understand verbal and written information
- No cognitive impairment
- To be able to speak and understand Turkish
Who cannot join
- Having a neurological disease
- Having a psychiatric disorder
- Visual or hearing loss that cannot be corrected with any assistive device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, 15100
About this study
Official title: 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.
Read more
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).
- Conditions
- Total Hip Arthroplasty (THA)
- Being tested
- Exercise
- Keywords
- total hip arthroplasty, telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
exercise programme will be implemented via telerehabilitation
ExerciseOther
exercise programme will be implemented via face-to-face
| Study group | Role | What they receive |
|---|---|---|
| Group 1: TR Group | Experimental | TR: telerehabilitation. During the follow-up period, a standard exercise programme will be applied to the TR group via videoconference-based telerehabilitation. Receives: Other: Exercise |
| Group 1: F2F Group | Experimental | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional level
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.
Measured: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
Secondary outcomes (5)
Pain intensity
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.
Measured: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
Quality of life
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.
Measured: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
Locomotor performance
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.
Measured: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
Lower extremity muscle strength
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.
Measured: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
Hip Joint Range of Motion (ROM)
Range of Motion (ROM) will be evaluated by goniometric measurement.
Measured: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip Arthroplasty (THA)Studies of the same condition, open and under way.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Principal investigator, Akın Süzer, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708884
- Sponsor's protocol ID
- ErsoyU.22112024
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Telerehabilitation a Good Alternative to Face-to-Face Rehabilitation Beyond Clinical Walls in Recovery After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT06708884
- Acronym / sponsor ID
- ErsoyU.22112024
- Conditions
- Total Hip Arthroplasty (THA)
- Keywords
- total hip arthroplasty, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 27 Nov 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: TR Group | Experimental | Other: ExerciseTR: telerehabilitation. During the follow-up period, a standard exercise programme will be applied to the TR group via videoconference-based telerehabilitation. |
| Group 1: F2F Group | Experimental | Other: ExerciseF2F: face to face. During the follow-up period, a standard exercise programme will be applied to the F2F group via face to face rehabilitation. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having hip arthroplasty surgery
- To be able to understand verbal and written information
- No cognitive impairment
- To be able to speak and understand Turkish
Key exclusion criteria (3 listed)
- Having a neurological disease
- Having a psychiatric disorder
- Visual or hearing loss that cannot be corrected with any assistive device
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 |
|---|---|---|
| Exerciseexercise programme will be implemented via telerehabilitation | Other | Group 1: TR Group |
| Exerciseexercise programme will be implemented via face-to-face | Other | Group 1: F2F Group |
Primary outcome
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.
5 secondary outcomes
Pain intensity
Time frame: 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.
Locomotor performance
Time frame: 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.
Hip Joint Range of Motion (ROM)
Time frame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Total Hip Arthroplasty (THA), run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 27 Nov 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akın Süzer, PT, PhD (05554843024, akinsuzer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional level (time frame: Assessments will be performed before surgery and at 6 weeks and 12 weeks after surgery.). 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 27 Nov 2024.