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

Sponsor

Rennes University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT00284115

Collaborator

Ministry of Health, France (Other)

122

Enrollment

Locations

Arms

Duration (Months)

10.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiplegia Stroke	Device: Gait trainer Device: Conventional rehabilitation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mechanical gait repetitive training Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement	Device: Gait trainer Mechanical gait repetitive training
Active Comparator: Conventional rehabilitation program Physiotherapeutic conventional rehabilitation program	Device: Conventional rehabilitation Physiotherapeutic conventional rehabilitation

Arm

Intervention/Treatment

Experimental: Mechanical gait repetitive training

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

Device: Gait trainer

Mechanical gait repetitive training

Active Comparator: Conventional rehabilitation program

Physiotherapeutic conventional rehabilitation program

Device: Conventional rehabilitation

Physiotherapeutic conventional rehabilitation

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Functional ambulatory category [Days 0, 15, 28 and 90.]
Walking endurance (6 minute walk) [days 15, 28 and 90.]
distance covered in a 6 minutes confortable walk
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]
Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance) [Days 0, 15, 28 and 90]
Economic evaluation (healthcare requirements, rehabilitation unit length of stay) [At the end of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger	Aulnay sous Bois	France	93602
2	Centre du Docteur Bouffart-Vercelli	Cerbère	France	66290
3	Centre de Rééducation de Coubert	Coubert	France	77170
4	Rééducation Fonctionnelle - Hôpital Raymond Poincaré	Garches	France	92380
5	Centre l'espoir	Hellemmes	France	59260
6	Centre Bretegnier	Héricourt	France	70400
7	Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol	Limoges	France	87000
8	Service de Médecine Physique et Réadaptation - Hôpital de l'Archet	Nice	France	06202
9	Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi	Nîmes	France	30029
10	Service de Rééducation Neuro-orthopédique - Hôpital Rothschild	Paris	France	75012
11	Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou	Rennes	France	35033
12	Centre de l'Arche	Saint Saturnin	France	72650