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Videographic Feedback and Walk Rehabilitation in Post-Cerebrovascular Accident (CoDévi)

Primary Purpose

Cerebrovascular Accident

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Videographic feedback
Classic reeducation
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU NiceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Classic reeducation

Classic reeducation + videographic feedback

Arm Description

Outcomes

Primary Outcome Measures

Walking speed
Difference in walking speed between the initial and final assessment in each group.

Secondary Outcome Measures

Full Information

First Posted
August 23, 2021
Last Updated
June 16, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05024981
Brief Title
Videographic Feedback and Walk Rehabilitation in Post-Cerebrovascular Accident
Acronym
CoDévi
Official Title
Videographic Feedback and Walk Rehabilitation in Post-Cerebrovascular Accident
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Classic reeducation
Arm Type
Active Comparator
Arm Title
Classic reeducation + videographic feedback
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Videographic feedback
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Classic reeducation
Intervention Description
The patient will benefit twice a day for 30 minutes from re-education sessions.
Primary Outcome Measure Information:
Title
Walking speed
Description
Difference in walking speed between the initial and final assessment in each group.
Time Frame
Day 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey MARTEU
Phone
4 92 03 40 80
Ext
+33
Email
marteu.a@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audrey MARTEU
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nice
City
Nice
State/Province
Alpes-Maritime
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey MARTEU
Phone
4 92 03 40 80
Ext
+33
Email
marteu.a@chu-nice.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Videographic Feedback and Walk Rehabilitation in Post-Cerebrovascular Accident

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