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

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00658710
First received: April 11, 2008
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Hemiplegia
Behavioral: physical therapy sessions

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • the average number of steps per day recorded over 3 days in an outpatient setting [ Time Frame: day 3 and then 6 months later ] [ Designated as safety issue: No ]

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) [ Time Frame: day 0 and then day 55 ] [ Designated as safety issue: No ]
  • for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: June 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
patients who continue physical therapy sessions during two months.
Behavioral: physical therapy sessions
two physical therapy sessions per week for two months
No Intervention: 2
patients who stop physical therapy sessions during two months

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00658710

Locations
France
Centre Régional de Réeducation et de Réadaptation Fonctionnelle
Angers, France, 49103
Groupe hospitalier Pellegrin CHU Bordeaux
Bordeaux, France, 33076
Hôpital J. Rebeyrol
Limoges, France, 87042
Institut Régional de médecine physique et de Réadaptation
Nancy, France, 54042
CHU de St Etienne
St Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Pascal Giraux, MD CHU ST Etienne
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00658710     History of Changes
Other Study ID Numbers: 0701040, 2007-A00747-46
Study First Received: April 11, 2008
Last Updated: November 6, 2013
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
hemiplegia
stroke
TRIDENT

Additional relevant MeSH terms:
Hemiplegia
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014