NCT05024981

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Mar 2022Jan 2027

First Submitted

Initial submission to the registry

August 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

March 4, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2027

Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

4.8 years

First QC Date

August 23, 2021

Last Update Submit

December 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Walking speed

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

    Day 26

Study Arms (2)

Classic reeducation

ACTIVE COMPARATOR
Behavioral: Classic reeducation

Classic reeducation + videographic feedback

EXPERIMENTAL
Behavioral: Videographic feedback

Interventions

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 reeducation + videographic feedback

The patient will benefit twice a day for 30 minutes from re-education sessions.

Classic reeducation

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nice

Nice, Alpes-Maritime, 06000, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Audrey MARTEU

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2021

First Posted

August 27, 2021

Study Start

March 4, 2022

Primary Completion (Estimated)

January 4, 2027

Study Completion (Estimated)

January 4, 2027

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations