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

NCT ID: NCT00658710

Last Updated: 2013-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2012-12-31

Brief 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.

Detailed 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 .

Conditions

Hemiplegia

Keywords

hemiplegia; stroke; TRIDENT

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

patients who continue physical therapy sessions during two months.

Group Type: ACTIVE_COMPARATOR

physical therapy sessions

Intervention Type: BEHAVIORAL

two physical therapy sessions per week for two months

2

patients who stop physical therapy sessions during two months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

physical therapy sessions

two physical therapy sessions per week for two months

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal Giraux, MD

Role: PRINCIPAL_INVESTIGATOR

CHU ST Etienne

Locations

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

Saint-Etienne, , France

Countries

France

Other Identifiers

2007-A00747-46

Identifier Type: -

Identifier Source: secondary_id

0701040

Identifier Type: -

Identifier Source: org_study_id