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

Fatigue Clinical Trial

Official title:

Evaluation of the Short Effects of a Rehabilitation Session on Gait Parameters in Patients With a Lesion of the Central Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807247
• Other study ID #: 2011-A01487-34
• Status: Completed
• Phase: N/A
• First received: March 7, 2013
• Last updated: February 3, 2015
• Start date: February 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2013
• Source: Centre d'Investigation Clinique et Technologique 805
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fall Due to Failure of Support
• Fatigue
• Spastic Gait

Intervention

Procedure:
• Intensive lower limbs muscles strengthening

Locations

Country	Name	City	State
France	Hopital Raymond Poincare	Garches

Sponsors (1)

Lead Sponsor	Collaborator
Centre d'Investigation Clinique et Technologique 805

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of functional capacity after rehabilitation session using functional tests such as 6 minutes walking test and timed up and go	clinical exam, timed up and go, stair test, 6 minutes walking test	30 min	No
Secondary	Evaluation of gait pattern and muscle activation patterns during video and EMG analyzes.	EMG analysis of rectus femoris, hamstrings, tibialis anterior and soleus	1 hour	No