Short Effects of a Rehabilitation Session on Gait in Patients With CNS

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Centre d'Investigation Clinique et Technologique 805
Sponsor:
Information provided by (Responsible Party):
Nicolas ROCHE, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier:
NCT01807247
First received: March 7, 2013
Last updated: September 25, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention
Spastic Gait
Fall Due to Failure of Support
Fatigue
Procedure: Intensive lower limbs muscles strengthening

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Short Effects of a Rehabilitation Session on Gait Parameters in Patients With a Lesion of the Central Nervous System

Resource links provided by NLM:


Further study details as provided by Centre d'Investigation Clinique et Technologique 805:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    clinical exam, timed up and go, stair test, 6 minutes walking test


Secondary Outcome Measures:
  • Evaluation of gait pattern and muscle activation patterns during video and EMG analyzes. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    EMG analysis of rectus femoris, hamstrings, tibialis anterior and soleus


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807247

Contacts
Contact: Nicolas ROCHE, MDPHD 33147107900 ext 5405 roche.nicolas@rpc.aphp.fr
Contact: Djamel BENSMAIL, MDPHD 33147107900 djamel.bensmail@rpc.aphp.fr

Locations
France
Hopital Raymond Poincare Recruiting
Garches, France, 92380
Contact: Nicolas ROCHE, MDPHD    33147107900 ext 5405    roche.nicolas@rpc.aphp.fr   
Contact: Sandra POTTIER, CRA    33147104469    sandra.pottier@rpc.aphp.fr   
Sub-Investigator: Djamel BENSMAIL, MDPHD         
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Investigators
Principal Investigator: Nicolas ROCHE, MDPHD Hôpital RAYMOND POINCARE
  More Information

No publications provided

Responsible Party: Nicolas ROCHE, MDPHD, Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT01807247     History of Changes
Other Study ID Numbers: 2011-A01487-34
Study First Received: March 7, 2013
Last Updated: September 25, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
Strengthening muscle
Central nervous system diseases
Gait

ClinicalTrials.gov processed this record on October 22, 2014