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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
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
January 30, 2006
Last Updated
July 3, 2012
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
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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
No

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
No
Eligibility Criteria
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
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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