NCT01383512

Brief Summary

Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Both groups will realize the same time of rehabilitation. The cost benefit ratio will be compared in each group through medical assessment of improvement and definition of the costs due to the rehabilitation process.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

23 active sites

Status
completed

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 Start

First participant enrolled

June 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2011

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

6.5 years

First QC Date

June 27, 2011

Last Update Submit

January 22, 2025

Conditions

Subacute Stroke

Keywords

strokerehabilitationroboticsmotor controlupper limb

Outcome Measures

Primary Outcomes (1)

  • Fugl Meyer upper limb motor score

    Increase of the Fugl Meyer score between day 0 and day 30 with a difference between groups by at least 4 points

    Day 30

Secondary Outcomes (4)

  • Costs

    One year

  • Stroke impact scale (SIS)

    One year

  • Visual analog scale (VAS)

    Day 7,14,21,30, 90,180, 360

  • Modification of motor control

    Day 30

Study Arms (3)

Rehabilitation robotics

EXPERIMENTAL

Subjects will be practicing an Armeo Spring rehabilitation program in addition to their usual care (1.5h/day,5d/week) 1h/day 5d/week 4 weeks.

Device: ARMEO Spring

Self-rehabilitation

ACTIVE COMPARATOR

Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation.

Other: Self rehabilitation

Healthy volunteer

OTHER

20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device.

Device: ARMEO Spring

Interventions

ARMEO SpringDEVICE

Use of the device 1 hour per day, 5 days per week during 4 weeks

Healthy volunteerRehabilitation robotics
Self rehabilitationOTHER

Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.

Self-rehabilitation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ischemic or hemorrhagic stroke of the middle cerebral arteria territory
  • to 80 years old
  • stroke onset between 3 weeks to 3 months,with or without aphasia, with or without lateral neglect and homonymous hemianopia, with or without visual neglect
  • \<or= Fugl Meyer upper limb Score \<or= 40
  • upper limbs pain less or equal than 3/10 (VAS)
  • inpatient or outpatient rehabilitation
  • signed inform consent

You may not qualify if:

  • ischemic or hemorrhagic stroke of anterior or posterior cerebral artery
  • ischemic or hemorrhagic stroke of the brainstem
  • major aphasia evaluated by a Boston Diagnostic Aphasia Examination (BDAE) score less or equal to 3
  • asthenia not allowing to work 60 minutes with the robot.
  • serious visual deficiency not allowing to use the robot
  • impossibility to install the arm on the robot because of a serious and uncontrolled spasticity or for any other reason
  • pronounced and constant muscular contractures, or deformation affecting the use of the extremity
  • upper limb's pain superior to 3/10 and/or being worse at the active and passive mobilization
  • serious infection and/or instability of vital functions
  • perfusion of the affected upper limb not removable
  • incapacity to stay on a chair
  • contraindicated sitting position
  • permanent deviation of the head and\\or of the eyes
  • perturbed or non-cooperative patient
  • patients that must have to be isolated due to an infection process
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

CHU d'Amiens

Amiens, 80000, France

Location

CRRRF

Angers, 49000, France

Location

CHU de Bordeaux

Bordeaux, 33073, France

Location

CHRU de Brest

Brest, 29609, France

Location

Centre Bouffard Vercelli

Cervera de la Marenda, 66290, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63118, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CH de Garches

Garches, 92380, France

Location

EMPR Le Normandy

Granville, 54000, France

Location

CHU de Nîmes

Le Grau-du-Roi, 30029, France

Location

CHRU de Lille

Lille, 59037, France

Location

CHU de Limoges

Limoges, 87042, France

Location

CHU de Lyon

Lyon, 69000, France

Location

CRF de Valmante

Marseille, 13275, France

Location

CHU de Montpellier

Montpellier, 34172, France

Location

IRR de Nancy

Nancy, 54690, France

Location

CHU de Nantes

Nantes, 44093, France

Location

APHP - Hôpital La Salpétriere

Paris, 75000, France

Location

APHP - Hôpital Lariboisière

Paris, 75000, France

Location

CMRRF Kerpape

Ploemeur, 56275, France

Location

CHU de Reims

Reims, 51100, France

Location

CHU de Rennes

Rennes, 35 033, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

Related Publications (2)

  • Cornec G, Lempereur M, Mensah-Gourmel J, Robertson J, Miramand L, Medee B, Bellaiche S, Gross R, Gracies JM, Remy-Neris O, Bayle N. Measurement properties of movement smoothness metrics for upper limb reaching movements in people with moderate to severe subacute stroke. J Neuroeng Rehabil. 2024 May 29;21(1):90. doi: 10.1186/s12984-024-01382-1.

    PMID: 38812037DERIVED

  • Remy-Neris O, Le Jeannic A, Dion A, Medee B, Nowak E, Poiroux E, Durand-Zaleski I; REM Investigative Team*. Additional, Mechanized Upper Limb Self-Rehabilitation in Patients With Subacute Stroke: The REM-AVC Randomized Trial. Stroke. 2021 Jun;52(6):1938-1947. doi: 10.1161/STROKEAHA.120.032545. Epub 2021 Apr 29.

    PMID: 33910364DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Olivier REMY-NERIS, Professor

    University Hospital, Brest

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 27, 2011

First Posted

June 28, 2011

Study Start

June 1, 2011

Primary Completion

December 5, 2017

Study Completion

December 5, 2017

Last Updated

January 23, 2025

Record last verified: 2025-01

Locations

FR(23)