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

This study is not yet open for participant recruitment.
Verified by Centre Hospitalier Universitaire de Saint Etienne, May 2008

Sponsors and Collaborators: Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire d'Angers
Centre Hospitalier Universitaire de Bordeaux
Centre Hospitalier Universitaire de Limoges
Centre Hospitalier Universitaire de Nancy
Information provided by: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00658710
  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

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:   Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients

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 ]

Estimated Enrollment:   240
Study Start Date:   June 2008
Estimated Study Completion Date:   June 2011
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
patients who continue physical therapy sessions during two months.
Behavioral: physical therapy sessions
two physical therapy sessions per week for two months
2: No Intervention
patients who stop physical therapy sessions during two months
Behavioral: physical therapy sessions
patients who stop two physical therapy sessions per week for 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

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

Contacts
Contact: Pascal GIRAUX, MD     04 77 12 77 56     pascal.giraux@univ-st-etienne.fr    

Locations
France
Centre Régional de Réeducation et de Réadaptation Fonctionnelle     Not yet recruiting
      ANGERS, France, 49103
      Contact: Isabelle RICHARD, MD     02 41 35 17 09     isabelle.richard@univ-angers.fr    
      Principal Investigator: Isabelle RICHARD, MD            
Groupe hospitalier Pellegrin CHU Bordeaux     Not yet recruiting
      BORDEAUX, France, 33076
      Contact: Pierre Alain JOSEPH, md     05 56 79 55 46     pierre-alain.joseph@chu-bordeaux.fr    
      Principal Investigator: Pierre-Alain JOSEPH, MD            
Hôpital J. Rebeyrol     Not yet recruiting
      LIMOGES, France, 87042
      Contact: Jean-Yves SALLE, MD     05 55 05 65 18     jean-yves.salle@chu-limoges.fr    
      Principal Investigator: Jean-Yves SALLE, MD            
Institut Régional de médecine physique et de Réadaptation     Not yet recruiting
      NANCY, France, 54042
      Contact: Christian BEYAERT, MD     03 83 52 98 22     christian.beyaert@medecine.uhp-nancy.fr    
      Principal Investigator: Christian BEYAERT, MD            
CHU de St Etienne     Not yet recruiting
      ST ETIENNE, France, 42055
      Contact: Pascal GIRAUX, MD     04 77 12 77 56     pascal.giraux@univ-st-etienne.fr    
      Principal Investigator: Pascal GIRAUX, MD            
      Sub-Investigator: Paul CALMELS, MD            

Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Centre Hospitalier Universitaire d'Angers
Centre Hospitalier Universitaire de Bordeaux
Centre Hospitalier Universitaire de Limoges
Centre Hospitalier Universitaire de Nancy

Investigators
Principal Investigator:     Pascal Giraux, MD     CHU ST Etienne    
  More Information


Responsible Party:   Centre Hospitalier Universitaire de Saint Etienne ( Françoise LORCA )
Study ID Numbers:   0701040
First Received:   April 11, 2008
Last Updated:   May 7, 2008
ClinicalTrials.gov Identifier:   NCT00658710
Health Authority:   France: Direction Générale de la Santé

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

Study placed in the following topic categories:
Paralysis
Signs and Symptoms
Hemiplegia
Cerebral Infarction
Stroke
Neurologic Manifestations

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008




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