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

Primary Purpose

Hemiplegia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
physical therapy sessions
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemiplegia focused on measuring hemiplegia, stroke, TRIDENT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Centre Régional de Réeducation et de Réadaptation Fonctionnelle
  • Groupe hospitalier Pellegrin CHU Bordeaux
  • Hôpital J. Rebeyrol
  • Institut Régional de médecine physique et de Réadaptation
  • CHU de St Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

1

2

Arm Description

patients who continue physical therapy sessions during two months.

patients who stop physical therapy sessions during two months

Outcomes

Primary Outcome Measures

the average number of steps per day recorded over 3 days in an outpatient setting

Secondary Outcome Measures

the scores to the scales (the 6 minutes walking test, the Wade's test, the Rivermead Mobility Index Score, the Barthel Index Score)
for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients

Full Information

First Posted
April 11, 2008
Last Updated
November 6, 2013
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00658710
Brief Title
Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients
Acronym
HEMIMARCHE
Official Title
Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
hemiplegia, stroke, TRIDENT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
patients who continue physical therapy sessions during two months.
Arm Title
2
Arm Type
No Intervention
Arm Description
patients who stop physical therapy sessions during two months
Intervention Type
Behavioral
Intervention Name(s)
physical therapy sessions
Intervention Description
two physical therapy sessions per week for two months
Primary Outcome Measure Information:
Title
the average number of steps per day recorded over 3 days in an outpatient setting
Time Frame
day 3 and then 6 months later
Secondary Outcome Measure Information:
Title
the scores to the scales (the 6 minutes walking test, the Wade's test, the Rivermead Mobility Index Score, the Barthel Index Score)
Time Frame
day 0 and then day 55
Title
for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Giraux, MD
Organizational Affiliation
CHU ST Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Régional de Réeducation et de Réadaptation Fonctionnelle
City
Angers
ZIP/Postal Code
49103
Country
France
Facility Name
Groupe hospitalier Pellegrin CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital J. Rebeyrol
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Institut Régional de médecine physique et de Réadaptation
City
Nancy
ZIP/Postal Code
54042
Country
France
Facility Name
CHU de St Etienne
City
St Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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