- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06780319
Digital Rehabilitation After Hip Arthroplasty: a Randomized Controlled Trial (Digihip)
June 10, 2025 updated by: Clinique du Sport, Bordeaux Mérignac
The study aims to compare the effectiveness of tele-rehabilitation versus no physical therapy after total hip arthroplasty (THA) in improving patient-reported outcomes and functional recovery.
THR is a common surgical procedure to relieve pain and improve function in patients with a variety of hip conditions.
Traditional physical therapy is a standard component of the post-operative care pathway for PTH patients, but can be hampered by logistical obstacles.
Tele-rehabilitation is emerging as a promising alternative, offering the potential to overcome these barriers and improve access to care.
The study uses a prospective monocentric design with two arms and a follow-up time of 6 months.
The primary objective is assessed using the Timed up and go Test (TUG), while secondary objectives include patient-reported outcome measures, patient satisfaction, healthcare utilization, and return to physical activity.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
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: Pierre Laboudie, MD
- Phone Number: +33671270463
- Email: pierre.laboudie@gmail.com
Study Locations
-
-
-
Merignac, France, 33700
- Recruiting
- Clinique du Sport
-
Contact:
- Pierre Laboudie, MD
- Phone Number: +33 (0)5 56 18 17 10
- Email: secretariatdrlaboudie@gmail.com
-
-
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:
- Have an email address and a smartphone
- Patient speaking and writing French
- Patient covered by a social security scheme
Exclusion Criteria:
- Hip revision surgery, significant comorbidities (Parkinson's disease, multiple sclerosis, stroke) or psychiatric disorders (substance use) that could interfere with rehabilitation
- Patients with disorders that make it difficult for them to express their feelings
- Pregnant or breast-feeding patients
- Patient under protective supervision
- Patient not covered by a social security scheme
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: standard rehabilitation
|
rehabilitation with a private physiotherapist.
Patients usually undergo 15 rehabilitation sessions, in line with HAS recommendations; the number of sessions can go up to 25, depending on the patient's profile and needs.
|
|
Experimental: Tele-rehabilitation
|
Tele-education is a digital home-based intervention involving exercises and education.
Patients are monitored remotely by a physiotherapist via a secure messaging system.
The system consists of a mobile application for the patient and a web portal enabling the physiotherapist to review patient data (physical activity, pain levels, medication use, exercise adherence, patient-reported results, images, videos) on a daily basis and tailor the protocol accordingly.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Up and Go test
Time Frame: 6 weeks and 6 months after surgery
|
The TUG is a clinical test used to assess patients' mobility and risk of falling.
It measures the time required for a person to stand up from a chair, walk a short distance, turn around, return to the chair and sit down.
|
6 weeks and 6 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
June 4, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
October 31, 2026
Study Registration Dates
First Submitted
January 13, 2025
First Submitted That Met QC Criteria
January 13, 2025
First Posted (Actual)
January 17, 2025
Study Record Updates
Last Update Posted (Actual)
June 11, 2025
Last Update Submitted That Met QC Criteria
June 10, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024-17-SBM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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-
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