Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients

Hemiplegia Clinical Trial

— HEMIMARCHE  

Official title:

Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00658710
• Other study ID #: 0701040
• Secondary ID: 2007-A00747-46
• Status: Terminated
• Phase: N/A
• First received: April 11, 2008
• Last updated: November 6, 2013
• Start date: June 2008
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: French Data Protection Authority
• Study type: Interventional

Clinical Trial Summary

The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months.Following the initial screening, subjects will be randomized into two groups: one who continues attending two physical therapy sessions per week for two months, or the other one who stops physical therapy sessions for two months. Before and after those two months, a 3 days recording will be made using an ambulatory system called TRIDENT.

Description:

The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months. This will permit us 1) to assess the efficacy of continuing physical therapy sessions during the chronic phase of post-stroke hemiplegia, 2) to investigate whether the effects of physical therapy in these patients gradually decreases during the period of six months to two years post-stroke, and 3) to model the relationship between standard measures of gait performance (speed, endurance, balance, use of technical aids…) with other multidimensional covariates: social and environmental factors (type of housing, presence of a third person,…), cognitive factors (cognitive disorders associated) and thymic factors (anxiety, depression) and 4) to assess the costs associated with the physical therapy care of chronic-phase stroke patients .

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients must be aged 18 to 75 years, with a first ischemic or hemorrhagic stroke at least six months ago and no longer than two years ago, without subsequent stroke. It must have caused initially complete hemiplegia of the right or left hemibody, but they must be able of walk alone with or without technical assistance over a distance of at least 10 meters They must be able change direction too.

• Finally, they must have a Functional Ambulation Classification (FAC) score between 4 and 6 during the inclusion.

Exclusion Criteria:

• We will exclude patients with a neurological history other than a stroke, a psychiatric illness, or an associated debilitating disease.

• They must not have an associated cerebella syndrome or a clinical brainstem attack.

• We will refuse patients who are pregnant, who have not signed the written consent, and who aren't entitled to a social security scheme.

Study Design

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

Related Conditions & MeSH terms

• Hemiplegia

Intervention

Behavioral:
• physical therapy sessions
two physical therapy sessions per week for two months

Locations

Country	Name	City	State
France	Centre Régional de Réeducation et de Réadaptation Fonctionnelle	Angers
France	Groupe hospitalier Pellegrin CHU Bordeaux	Bordeaux
France	Hôpital J. Rebeyrol	Limoges
France	Institut Régional de médecine physique et de Réadaptation	Nancy
France	CHU de St Etienne	St Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the average number of steps per day recorded over 3 days in an outpatient setting		day 3 and then 6 months later	No
Secondary	the scores to the scales (the 6 minutes walking test, the Wade's test, the Rivermead Mobility Index Score, the Barthel Index Score)		day 0 and then day 55	No
Secondary	for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients		6 months	No