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Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients (AVC)

Primary Purpose

Hemiplegia, Stroke

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Gait trainer

Conventional rehabilitation

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring Gait trainer, Hemiplegia, Rehabilitation, Stroke

Eligibility Criteria

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

Inclusion Criteria: Men or women aged 18 years or more Hemiplegia secondary to stroke Interval between stroke and study inclusion of 4 month or less 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 Exclusion Criteria: Orthopedic and/or rheumatological disease impairing mobility Other Neurological associated disease History of myocardial infarction or deep venous embolism or pulmonary embolism less than 3 months before study inclusion Chronic pulmonary disease Intolerance to stand up

Sites / Locations

Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger
Centre du Docteur Bouffart-Vercelli
Centre de Rééducation de Coubert
Rééducation Fonctionnelle - Hôpital Raymond Poincaré
Centre l'espoir
Centre Bretegnier
Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol
Service de Médecine Physique et Réadaptation - Hôpital de l'Archet
Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi
Service de Rééducation Neuro-orthopédique - Hôpital Rothschild
Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
Centre de l'Arche

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mechanical gait repetitive training

Conventional rehabilitation program

Arm Description

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

Physiotherapeutic conventional rehabilitation program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Functional ambulatory category

Walking endurance (6 minute walk)

distance covered in a 6 minutes confortable walk

Time to self sufficient gait recovery

Spasticity (modified Ashworth score)

Motricity index

Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)

Economic evaluation (healthcare requirements, rehabilitation unit length of stay)

Full Information

NCT ID

NCT00284115

First Posted

January 30, 2006

Last Updated

July 3, 2012

Sponsor

Rennes University Hospital

Collaborators

Ministry of Health, France

1. Study Identification

Unique Protocol Identification Number

NCT00284115

Brief Title

Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients (AVC)

Official Title

Efficacy of a Mechanical Gait Repetitive Training Technique Compared With a Usual Rehabilitation Program on Gait Recovery in Hemiparetic Stroke Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Study Start Date

March 2006 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

Collaborators

Ministry of Health, France

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. The aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. Hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone. The primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. Functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.

6. Conditions and Keywords

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

Hemiplegia, Stroke

Keywords

Gait trainer, Hemiplegia, Rehabilitation, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

122 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mechanical gait repetitive training

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional rehabilitation program

Arm Type

Active Comparator

Arm Description

Physiotherapeutic conventional rehabilitation program

Intervention Type

Device

Intervention Name(s)

Gait trainer

Intervention Description

Mechanical gait repetitive training

Intervention Type

Device

Intervention Name(s)

Conventional rehabilitation

Intervention Description

Physiotherapeutic conventional rehabilitation

Primary Outcome Measure Information:

Title

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

Time Frame

after 4 weeks

Secondary Outcome Measure Information:

Title

Functional ambulatory category

Time Frame

Days 0, 15, 28 and 90.

Title

Walking endurance (6 minute walk)

Description

distance covered in a 6 minutes confortable walk

Time Frame

days 15, 28 and 90.

Title

Time to self sufficient gait recovery

Time Frame

Since inclusion Time

Title

Spasticity (modified Ashworth score)

Time Frame

Days 0, 15, 28 and 90

Title

Motricity index

Time Frame

Days 0, 15, 28 and 90

Title

Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)

Time Frame

Days 0, 15, 28 and 90

Title

Economic evaluation (healthcare requirements, rehabilitation unit length of stay)

Time Frame

At the end of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Régine Brissot, MD

Organizational Affiliation

CHU Rennes

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bruno Laviolle, MD

Organizational Affiliation

CHU Rennes

Official's Role

Study Chair

Facility Information:

Facility Name

Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger

City

Aulnay sous Bois

ZIP/Postal Code

93602

Country

France

Facility Name

Centre du Docteur Bouffart-Vercelli

City

Cerbère

ZIP/Postal Code

66290

Country

France

Facility Name

Centre de Rééducation de Coubert

City

Coubert

ZIP/Postal Code

77170

Country

France

Facility Name

Rééducation Fonctionnelle - Hôpital Raymond Poincaré

City

Garches

ZIP/Postal Code

92380

Country

France

Facility Name

Centre l'espoir

City

Hellemmes

ZIP/Postal Code

59260

Country

France

Facility Name

Centre Bretegnier

City

Héricourt

ZIP/Postal Code

70400

Country

France

Facility Name

Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol

City

Limoges

ZIP/Postal Code

87000

Country

France

Facility Name

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

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

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

City

Nîmes

ZIP/Postal Code

30029

Country

France

Facility Name

Service de Rééducation Neuro-orthopédique - Hôpital Rothschild

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Centre de l'Arche

City

Saint Saturnin

ZIP/Postal Code

72650

Country

France

12. IPD Sharing Statement

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Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients (AVC)

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