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

NCT00658710 | Terminated DMC

• 2 other identifiers: 07010402007-A00747-46
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

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.

Conditions

Hemiplegia

Keywords

hemiplegia; stroke; TRIDENT

Outcome Measures

Primary Outcomes (1)

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

  day 3 and then 6 months later

Secondary Outcomes (2)

• the scores to the scales (the 6 minutes walking test, the Wade's test, the Rivermead Mobility Index Score, the Barthel Index Score)

  day 0 and then day 55

• for the medico-economic study, the direct medical and non-medical costs associated with physical therapy of chronic stroke patients

  6 months

Study Arms (2)

1

ACTIVE COMPARATOR

patients who continue physical therapy sessions during two months.

Behavioral: physical therapy sessions

2

NO INTERVENTION

patients who stop physical therapy sessions during two months

Interventions

physical therapy sessions BEHAVIORAL

two physical therapy sessions per week for two months

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (5)

Centre Régional de Réeducation et de Réadaptation Fonctionnelle

Angers, 49103, France

Location

Groupe hospitalier Pellegrin CHU Bordeaux

Bordeaux, 33076, France

Location

Hôpital J. Rebeyrol

Limoges, 87042, France

Location

Institut Régional de médecine physique et de Réadaptation

Nancy, 54042, France

Location

CHU de St Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Hemiplegia; Stroke

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pascal Giraux, MD

  CHU ST Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 15, 2008
• Study Start: June 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 7, 2013

Record last verified: 2013-11

Locations

FR (5)