- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01807247
Short Effects of a Rehabilitation Session on Gait in Patients With CNS
February 3, 2015 updated by: Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805
Evaluation of the Short Effects of a Rehabilitation Session on Gait Parameters in Patients With a Lesion of the Central Nervous System
The aim of the study is to evaluate the short effects of a two rehabilitation session commonly performed in physical therapy,
- muscle strengthening of the lower limbs and
- effort reconditioning with cyclo ergometer, on gait characteristics (kinematics, kinetics and electromyographic) in patients with central nervous system lesion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Garches, France, 92380
- Hôpital Raymond Poincaré
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The population includes patients with various lesions of central nervous system such as post-stroke patients with hemiparesis, patients with spinal cord injury and patients with mutiple sclerosis.
Description
Inclusion Criteria:
- Male or female adults aged ≥ 18 years receiving a motor rehabilitation in the service
- Hemiplegia after stroke or paraplegia incomplete ASIA C or D or multiple sclerosis (EPSS <5).
- Walking with or without technical assistance
- Patients who received and signed information and informed consent
- Patient who received physiotherapy session for rehabilitation of the lower limbs
- Patients able to perform the entire study
Exclusion Criteria:
- Patient with safety measure
- Pregnant women, breastfeeding
- Patient who has received botulinum toxin injection of in the lower limbs between 3 weeks and 2 months prior to inclusion in the study
- Bilateral Brain damage, cerebellar syndrome, apraxia, severe aphasia
- Orthopedic complications preventing walking
- Patients who participated in a clinical study within 3 months prior to inclusion • No affiliation to a social security scheme (beneficiary or assignee)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hemiparetic
Intensive lower limbs muscles strengthening
|
|
Spinal cord injury
Intensive lower limbs muscles strengthening
|
|
Multiple sclerosis
Intensive lower limbs muscles strengthening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of functional capacity after rehabilitation session using functional tests such as 6 minutes walking test and timed up and go
Time Frame: 30 min
|
clinical exam, timed up and go, stair test, 6 minutes walking test
|
30 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of gait pattern and muscle activation patterns during video and EMG analyzes.
Time Frame: 1 hour
|
EMG analysis of rectus femoris, hamstrings, tibialis anterior and soleus
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nicolas ROCHE, MDPHD, Hôpital Raymond Poincaré
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
March 7, 2013
First Submitted That Met QC Criteria
March 7, 2013
First Posted (Estimate)
March 8, 2013
Study Record Updates
Last Update Posted (Estimate)
February 4, 2015
Last Update Submitted That Met QC Criteria
February 3, 2015
Last Verified
March 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-A01487-34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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