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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Hemiplegia

Treatments: Behavioral: physical therapy sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT00658710

0701040

2007-A00747-46

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

1

Active Comparator group

Description:

patients who continue physical therapy sessions during two months.

Treatment:

Behavioral: physical therapy sessions

2

No Intervention group

Description:

patients who stop physical therapy sessions during two months