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,

  1. muscle strengthening of the lower limbs and
  2. 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

  • France
      • Garches, France, 92380
        • Hopital Raymond Poincare

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
Procedure: Intensive lower limbs muscles strengthening
Spinal cord injury
Intensive lower limbs muscles strengthening
Procedure: Intensive lower limbs muscles strengthening
Multiple sclerosis
Intensive lower limbs muscles strengthening
Procedure: 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.

Sponsor

Centre d'Investigation Clinique et Technologique 805

Investigators

  • Principal Investigator: Nicolas ROCHE, MDPHD, Hopital Raymond Poincare

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

Keywords

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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