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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 |
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: | Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients |
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.
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Behavioral: physical therapy sessions
two physical therapy sessions per week for two months
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2: No Intervention
patients who stop physical therapy sessions during two months
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Behavioral: physical therapy sessions
patients who stop two physical therapy sessions per week for two months
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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 .
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pascal GIRAUX, MD | 04 77 12 77 56 | pascal.giraux@univ-st-etienne.fr |
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 |
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 |
Principal Investigator: | Pascal Giraux, MD | CHU ST Etienne |
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 |
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