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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00284115
• Other study ID #: AFSSAPS 2005/10/006
• Secondary ID: PHRC/04-02
• Status: Terminated
• Phase: N/A
• First received: January 30, 2006
• Last updated: July 3, 2012
• Start date: March 2006
• Est. completion date: May 2011

Study information

• Verified date: July 2012
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 122
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Device:
• Gait trainer
Mechanical gait repetitive training
• Conventional rehabilitation
Physiotherapeutic conventional rehabilitation

Locations

Country	Name	City	State
France	Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger	Aulnay sous Bois
France	Centre du Docteur Bouffart-Vercelli	Cerbère
France	Centre de Rééducation de Coubert	Coubert
France	Rééducation Fonctionnelle - Hôpital Raymond Poincaré	Garches
France	Centre l'espoir	Hellemmes
France	Centre Bretegnier	Héricourt
France	Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol	Limoges
France	Service de Médecine Physique et Réadaptation - Hôpital de l'Archet	Nice
France	Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi	Nîmes
France	Service de Rééducation Neuro-orthopédique - Hôpital Rothschild	Paris
France	Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou	Rennes
France	Centre de l'Arche	Saint Saturnin

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program		after 4 weeks	No
Secondary	Functional ambulatory category		Days 0, 15, 28 and 90.	No
Secondary	Walking endurance (6 minute walk)	distance covered in a 6 minutes confortable walk	days 15, 28 and 90.	No
Secondary	Time to self sufficient gait recovery		Since inclusion Time	No
Secondary	Spasticity (modified Ashworth score)		Days 0, 15, 28 and 90	No
Secondary	Motricity index		Days 0, 15, 28 and 90	No
Secondary	Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)		Days 0, 15, 28 and 90	No
Secondary	Economic evaluation (healthcare requirements, rehabilitation unit length of stay)		At the end of the study	No