NCT00284115

Brief Summary

Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

January 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2006

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

5.2 years

First QC Date

January 30, 2006

Last Update Submit

July 3, 2012

Conditions

HemiplegiaStroke

Keywords

Gait trainerHemiplegiaRehabilitationStroke

Outcome Measures

Primary Outcomes (1)

  • Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program

    after 4 weeks

Secondary Outcomes (7)

  • Functional ambulatory category

    Days 0, 15, 28 and 90.

  • Walking endurance (6 minute walk)

    days 15, 28 and 90.

  • Time to self sufficient gait recovery

    Since inclusion Time

  • Spasticity (modified Ashworth score)

    Days 0, 15, 28 and 90

  • Motricity index

    Days 0, 15, 28 and 90

  • +2 more secondary outcomes

Study Arms (2)

Mechanical gait repetitive training

EXPERIMENTAL

Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement

Device: Gait trainer

Conventional rehabilitation program

ACTIVE COMPARATOR

Physiotherapeutic conventional rehabilitation program

Device: Conventional rehabilitation

Interventions

Gait trainerDEVICE

Mechanical gait repetitive training

Mechanical gait repetitive training
Conventional rehabilitationDEVICE

Physiotherapeutic conventional rehabilitation

Conventional rehabilitation program

Eligibility Criteria

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

You may qualify if:

  • Men or women aged 18 years or more
  • Hemiplegia secondary to stroke
  • First supratentorial stroke or no motor sequelae in case of history of transient ischemic stroke
  • Non ambulatory patient (Functional Ambulatory Category Stage 0 or 1)
  • Being able to sit unsupported at the edge of the bed
  • No severe impairment of cognition or communication
  • Written informed consent

You may not qualify if:

  • Orthopedic and/or rheumatological disease impairing mobility
  • Other Neurological associated disease
  • Chronic pulmonary disease
  • Intolerance to stand up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger

Aulnay-sous-Bois, 93602, France

Location

Centre du Docteur Bouffart-Vercelli

Cervera de la Marenda, 66290, France

Location

Centre de Rééducation de Coubert

Coubert, 77170, France

Location

Rééducation Fonctionnelle - Hôpital Raymond Poincaré

Garches, 92380, France

Location

Centre l'espoir

Hellemmes-Lille, 59260, France

Location

Centre Bretegnier

Héricourt, 70400, France

Location

Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol

Limoges, 87000, France

Location

Service de Médecine Physique et Réadaptation - Hôpital de l'Archet

Nice, 06202, France

Location

Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi

Nîmes, 30029, France

Location

Service de Rééducation Neuro-orthopédique - Hôpital Rothschild

Paris, 75012, France

Location

Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre de l'Arche

Saint-Saturnin, 72650, France

Location

MeSH Terms

Conditions

HemiplegiaStroke

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Régine Brissot, MD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

  • Bruno Laviolle, MD

    CHU Rennes

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 30, 2006

First Posted

January 31, 2006

Study Start

March 1, 2006

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

FR(12)