NCT01807247

Brief Summary

The aim of the study is to evaluate the short effects of a two rehabilitation session commonly performed in physical therapy,

  1. 1.muscle strengthening of the lower limbs and
  2. 2.effort reconditioning with cyclo ergometer, on gait characteristics (kinematics, kinetics and electromyographic) in patients with central nervous system lesion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 8, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

February 4, 2015

Status Verified

March 1, 2013

Enrollment Period

1.7 years

First QC Date

March 7, 2013

Last Update Submit

February 3, 2015

Conditions

Keywords

Strengthening muscleCentral nervous system diseasesGait

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Evaluation of gait pattern and muscle activation patterns during video and EMG analyzes.

    1 hour

Study Arms (3)

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

Interventions

HemipareticMultiple sclerosisSpinal cord injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Patient with safety measure
  • Pregnant women, breastfeeding
  • Bilateral Brain damage, cerebellar syndrome, apraxia, severe aphasia
  • Orthopedic complications preventing walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Raymond Poincare

Garches, Garches, 92380, France

Location

MeSH Terms

Conditions

Gait Disorders, NeurologicFatigueCentral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicolas ROCHE, MDPHD

    Hôpital RAYMOND POINCARE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MDPHD

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 8, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

February 4, 2015

Record last verified: 2013-03

Locations