Clinical trial NCT00658710: Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients
Official title: Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hemiplegia
Keywords: hemiplegia
stroke
TRIDENT
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2008-04-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 .

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.

Primary outcomes:
measure: the average number of steps per day recorded over 3 days in an outpatient setting
timeFrame: day 3 and then 6 months later
Secondary outcomes:
measure: the scores to the scales (the 6 minutes walking test, the Wade's test, the Rivermead Mobility Index Score, the Barthel Index Score)
timeFrame: day 0 and then day 55
measure: for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Régional de Réeducation et de Réadaptation Fonctionnelle
city: Bordeaux
country: France
facility: Groupe hospitalier Pellegrin CHU Bordeaux
city: Limoges
country: France
facility: Hôpital J. Rebeyrol
city: Nancy
country: France
facility: Institut Régional de médecine physique et de Réadaptation
city: St Etienne
country: France
facility: CHU de St Etienne
Study officials:
affiliation: CHU ST Etienne
name: Pascal Giraux, MD
role: PRINCIPAL_INVESTIGATOR
References: