Digital Rehabilitation After Hip Arthroplasty: a Randomized Controlled Trial (Digihip)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Pierre Laboudie, MD
- Phone Number: +33671270463
- Email: pierre.laboudie@gmail.com
Study Locations
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-
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Mérignac, France, 33700
- Recruiting
- Clinique du Sport
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Contact:
- Pierre Laboudie, MD
- Phone Number: +33 (0)5 56 18 17 10
- Email: secretariatdrlaboudie@gmail.com
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: standard rehabilitation
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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.
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Experimental: Tele-rehabilitation
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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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Up and Go test
Time Frame: 6 weeks and 6 months after surgery
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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.
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6 weeks and 6 months after surgery
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2024-17-SBM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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