- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05024981
Videographic Feedback and Walk Rehabilitation in Post-Cerebrovascular Accident (CoDévi)
December 6, 2024 updated by: Centre Hospitalier Universitaire de Nice
Cerebrovascular Accident affects the majority of the elderly population and its frequency is constantly increasing.
The resulting deficits are numerous and lead in particular to an alteration in the quality of walking and autonomy.
Numerous rehabilitation techniques have been described.
In practice, correction instructions are often given by the therapist while the motor activity is being performed.
Walking is a complex activity, as is the processing of dual-task information in elderly stroke patients.
It therefore appears interesting to separate the time of motor realization and that of correction instructions.
Investigators therefore propose firstly to film the patient during the performance of a walking activity and then, secondly, to analyse the video with the patient, which thus represents a source of delayed feedback.
The main objective of the study is to observe the effects of this practice on walking speed.
Investigators are comparing two groups of patients: the control group receiving conventional rehabilitation and the experimental group receiving conventional rehabilitation plus sessions with the video tool.
They expect to observe a greater improvement in walking speed in the experimental group.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
64
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: Audrey MARTEU
- Phone Number: +33 4 92 03 40 80
- Email: marteu.a@chu-nice.fr
Study Locations
-
-
Alpes-Maritime
-
Nice, Alpes-Maritime, France, 06000
- Recruiting
- CHU Nice
-
Contact:
- Audrey MARTEU
- Phone Number: +33 4 92 03 40 80
- Email: marteu.a@chu-nice.fr
-
-
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
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Hospitalization for a first episode of Cerebrovascular Accident less than six months old, or nth stroke less than six months old, with no previous sequelae;
- Able to walk at least 10m without stopping, with or without technical assistance, but without human assistance, under supervision;
Exclusion Criteria:
- Palliative or life-threatening situation;
- A patient whose guardian or trustee is not readily available to provide information about the patient
- Neuro-cognitive disorder that prevents understanding of instructions, as determined by the clinician;
- Severe speech or language disorder that prevents the protocol from being carried out correctly;
- Hemineglect;
- Any previously known pathology altering the gait pattern, at the clinician's discretion (recent neurological, traumatological or orthopaedic pathologies, etc.);
- Visual disorder preventing viewing of the video;
- Hearing disorder preventing comprehension.
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 |
|---|---|
|
Active Comparator: Classic reeducation
|
The patient will benefit twice a day for 30 minutes from re-education sessions.
|
|
Experimental: Classic reeducation + videographic feedback
|
Twice a week during his classic re-education sessions, the patient will be filmed for 1 minute.
After transferring the video to a tablet, he will watch the video once and decide what he wants to correct.
During the second viewing, he will analyse his walk, the therapist being present to provide additional information.
Finally, the patient will apply his analysis while being filmed and will compare the possible differences between the 2 videos.
Depending on the time available, the patient may have to repeat the recordings, analyses and exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking speed
Time Frame: Day 26
|
Difference in walking speed between the initial and final assessment in each group.
|
Day 26
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Audrey MARTEU, Centre Hospitalier Universitaire de Nice
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)
March 4, 2022
Primary Completion (Estimated)
January 4, 2027
Study Completion (Estimated)
January 4, 2027
Study Registration Dates
First Submitted
August 23, 2021
First Submitted That Met QC Criteria
August 23, 2021
First Posted (Actual)
August 27, 2021
Study Record Updates
Last Update Posted (Estimated)
December 11, 2024
Last Update Submitted That Met QC Criteria
December 6, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-GIRCI-02
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.
Clinical Trials on Cerebrovascular Accident
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Heart and Stroke Foundation...CompletedStroke | Vascular Accident, Brain | Stroke, Acute | Cerebrovascular Accident | Cerebral Stroke | Cerebrovascular Stroke | Cerebrovascular Accident, Acute | Apoplexy | CVA | Cerebrovascular ApoplexyCanada
-
China Medical University HospitalRecruitingCerebrovascular Accident (CVA)Taiwan
-
Sheba Medical CenterCompletedLate Effects of Cerebrovascular Accident
-
Universitaire Ziekenhuizen KU LeuvenCompletedTranscranial Direct Current Stimulation | Cerebrovascular Accident (CVA)Belgium
-
Sunnyview Rehabilitation HospitalCompletedStroke | Stroke, Acute | Cerebrovascular Accident | Cerebrovascular Accident, AcuteUnited States
-
Peking University Third HospitalAstraZeneca Investment (China) Co., LtdCompletedCerebrovascular Accident | Cerebrovascular Accident, AcuteChina
-
Medical University of South CarolinaIcahn School of Medicine at Mount SinaiCompletedIschemic Cerebrovascular AccidentUnited States
-
John DavidsonWashington University School of MedicineWithdrawnIschemic Cerebrovascular AccidentUnited States
-
University of California, IrvineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingStroke, Ischemic | Cerebrovascular Accident (CVA)United States
-
Fondation Ophtalmologique Adolphe de RothschildNot yet recruiting
Clinical Trials on Classic reeducation
-
University of Sao PauloConselho Nacional de Desenvolvimento Científico e TecnológicoCompletedMedian Nerve Disease | Ulnar Nerve Disease | Peripheral Nerve DiseaseBrazil
-
University Hospital Center of MartiniqueRecruitingParkinson Disease | Rehabilitation | Physical MedicineMartinique
-
Federal University of BahiaRecruiting
-
Assistance Publique - Hôpitaux de ParisRecruitingHereditary Spastic ParaparesisFrance
-
Lille Catholic UniversityTerminatedMultiple SclerosisFrance
-
Cairo UniversityCompletedLow Back Pain, PosturalEgypt
-
University of JaénCompletedFoot Deformities | Hallux Valgus | Hallux DeformitySpain
-
National Cheng-Kung University HospitalCompletedSensation Disorders | Rehabilitation | Motor DeficitTaiwan
-
Universidad de ZaragozaAragon Institute of Health SciencesCompletedEquilibrium; Disorder, Labyrinth | Spatial Navigation | Inner Ear DiseaseSpain
-
Investigación en Hemofilia y FisioterapiaCompleted