NCT05772663

Brief Summary

Mixed qualitative and quantitative study, in two phases: Creation of a self-rehabilitation program based on people's daily living activities and designed with and for them. Randomized controlled study to explore whether there is a potential benefit for patients with chronic stroke to use a self-rehabilitation program.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for not_applicable stroke

Timeline
28mo left

Started Nov 2025

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Nov 2025Sep 2028

First Submitted

Initial submission to the registry

February 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
2.6 years until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

November 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.8 years

First QC Date

February 10, 2023

Last Update Submit

November 18, 2025

Conditions

Stroke

Keywords

Strokeself-rehabilitation program

Outcome Measures

Primary Outcomes (4)

  • Assessment of Motor and Process Skills AMPS°

    The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.

    Day -7

  • Assessment of Motor and Process Skills AMPS°

    The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.

    Day 0

  • Assessment of Motor and Process Skills AMPS°

    The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.

    Day 56

  • Assessment of Motor and Process Skills AMPS°

    The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.

    Day112

Secondary Outcomes (11)

  • Canadian Occupational Performance Measure (COPM)

    Day -7

  • Canadian Occupational Performance Measure (COPM)

    Day 0

  • Canadian Occupational Performance Measure (COPM)

    Day 56

  • Canadian Occupational Performance Measure (COPM)

    Day 112

  • Satisfaction. Visual Analogic Scale (Satisfaction VAS)

    D56

  • +6 more secondary outcomes

Study Arms (2)

personalized program group

EXPERIMENTAL

people with chronic stroke

Other: Personalized program of rehabilitation

routine rehabilitation care group

ACTIVE COMPARATOR

people with chronic stroke

Other: Routine program of rehabilitation

Interventions

Personalized program of rehabilitationOTHER

D56: Follow-up visit (D56). Assessments: AMPS, MCRO, Satisfaction VAS. Installation of accelerometer wristbands for the sub-sample of 40 people with stroke drawn at random secondary accelerometry analysis. Between D56 and D112: For 8 weeks, the person does not receive any intervention apart from their usual rehabilitation. At D63, the person returns the accelerometric wristbands. D112: The assessments carried out by occupational therapist are: AMPS, MCRO. Installation of accelerometer bracelets for the sub-sample of 40 people with stroke, randomly selected for secondary analysis on accelerometers (subjects from the two groups, experimental and control, i.e. 20\*20). At D119, the person returns the accelerometric writbands.

personalized program group
Routine program of rehabilitationOTHER

Assessments: AMPS, MCRO, Satisfaction VAS. Installation of accelerometer wristbands for the sub-sample of 40 people with stroke drawn at random secondary accelerometry analysis. Between D56 and D112: For 8 weeks, the person does not receive any intervention apart from their usual rehabilitation. At D63, the person returns the accelerometric wristbands. D112: The assessments carried out by occupational therapist are: AMPS, MCRO. Installation of accelerometer bracelets for the sub-sample of 40 people with stroke, randomly selected for secondary analysis on accelerometers (subjects from the two groups, experimental and control, i.e. 20\*20). At D119, the person returns the accelerometric writbands.

routine rehabilitation care group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having had a single cerebral hemispheric lesion
  • Patient informed and having signed consent

You may not qualify if:

  • Patient under guardianship or curatorship
  • Pregnant or breastfeeding women
  • Cognitive impairment defined by BDAE \<3
  • Total absence of motor skills in the upper limb hemiplegic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Technilogy Platform department, Raymond Poincaré hospital - APHP

Garches, 92380, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Samuel POUPLIN, PhD

    New technology Platform department, Raymond Poincaré hospital -APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel POUPLIN, PhD

CONTACT

+ 33 01.47.10.70.61samuel.pouplin@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2023

First Posted

March 16, 2023

Study Start

November 1, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

November 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)