Cerebrovascular AccidentCoDéviNCT05024981
Videographic Feedback and Walk Rehabilitation in Post-Cerebrovascular Accident
A study testing Videographic feedback and Classic reeducation in people with Cerebrovascular Accident, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Videographic feedback and Classic reeducation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2022to 4 Jan 2027
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nice
Nice, Alpes-Maritime, 06000
Audrey MARTEU, 4 92 03 40 80 ext. +33, marteu.a@chu-nice.fr
About this study
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.
- Conditions
- Cerebrovascular Accident
- Being tested
- Videographic feedback, Classic reeducation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videographic feedbackBehavioural
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.
Classic reeducationBehavioural
The patient will benefit twice a day for 30 minutes from re-education sessions.
| Study group | Role | What they receive |
|---|---|---|
| Classic reeducation | Active comparator | Not described Receives: Behavioral: Classic reeducation |
| Classic reeducation + videographic feedback | Experimental | Not described Receives: Behavioral: Videographic feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed
Difference in walking speed between the initial and final assessment in each group.
Measured: Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start4 Mar 2022
- Primary completion4 Jan 2027 (estimated)
- Study completion4 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Audrey MARTEU, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024981
- Sponsor's protocol ID
- 19-GIRCI-02
- Acronym
- CoDévi
- Status last verified
- Dec 2024
- First submitted
- 23 Aug 2021
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videographic Feedback and Walk Rehabilitation in Post-Cerebrovascular Accident
- ClinicalTrials.gov ID
- NCT05024981
- Acronym / sponsor ID
- CoDévi / 19-GIRCI-02
- Conditions
- Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 4 Jan 2027 (estimated)
- First posted
- 27 Aug 2021 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic reeducation | Active comparator | Behavioral: Classic reeducation |
| Classic reeducation + videographic feedback | Experimental | Behavioral: Videographic feedback |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
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 |
|---|---|---|
| Videographic feedbackTwice 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. | Behavioural | Classic reeducation + videographic feedback |
| Classic reeducationThe patient will benefit twice a day for 30 minutes from re-education sessions. | Behavioural | Classic reeducation |
Primary outcome
Walking speed
Time frame: Day 26
Difference in walking speed between the initial and final assessment in each group.
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 11 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Audrey MARTEU principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videographic feedback and Classic reeducation in people with Cerebrovascular Accident, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 Dec 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 France. 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 Audrey MARTEU (4 92 03 40 80 ext. +33, marteu.a@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking speed (time frame: Day 26). 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 11 Dec 2024.