Interests of Strengthening Isokinetic Upper Extremity Hemiparetic Sequelae in Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01554137
First received: March 12, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

Stroke (CVA) is the leading cause of death and the leading cause of disability in developed countries as in developing countries (WHO, 2000). In the aftermath of a stroke, patients keep a permanent disability in 75% of cases and only one quarter of them is able to resume work. The post stroke sequelae are sensory-motor and cognitive.

According to literature data, 75-83% of patients who survive a stroke learn to walk only 25 to 45% recover use of their upper limb in activities of daily living (Friedman, 1990).

The existence of a phase called "plateau" in motor recovery after stroke has been suggested (Colautti, 2001). This would occur beyond the 4 th month and would correspond to a phase where the rehabilitation techniques used in the subacute phase are deemed less effective. Recently, Page (2004) speculated that this plateau phase is rather the consequence of adaptation to the type of patient follow-up training and not that of a limit to the possibilities of recovery. In an observational study on the recovery of upper limb conducted over a period of 4 years, Broeks (2004) showed a possible recovery beyond 16 weeks post stroke. The results of studies on different techniques for rehabilitation of chronic stroke patients tend to confirm the hypothesis of page. Therefore, varying the training parameters (type, intensity, frequency) could improve the functional capabilities of these patients, even at a distance of stroke.

Strength training is part of the management of hemiparetic patients. The results of several studies show an improvement in muscle strength and functional ability to walk after a building program isokinetic lower limb (Sharp, 1997).

The objective of our project is to evaluate the effectiveness of a building program of isokinetic muscle on the paretic limb motor recovery in hemiparetic patients over 6 months of a stroke.


Condition Intervention
Partial Deficiency of Muscle Strength
Other: isokinetic strength training
Other: passive motion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Interests of Strengthening Isokinetic Upper Extremity Hemiparetic Sequelae in Patients

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • upper limb motor function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    improving upper limb motor recovery at the end of the program is evaluated by the Fugl-Meyer test.This test evaluates motor impairment of the hemiplegic upper limb, balance, sensitivity, passive joint mobility and joint pain at mobilization.


Estimated Enrollment: 30
Study Start Date: October 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: With isokinetic strength training
60 minutes isokinetic strength training on concentric mode
Other: isokinetic strength training
The experimental group will follow a program of 18 sessions (3 sessions per week for 6 weeks) with a physiotherapy treatment (30 minutes) and occupational therapy (30 minutes), and a building session isokinetic concentric mode extensor and flexor muscles of the elbow extensors and wrist flexors.
Placebo Comparator: without isokinetic strength training
passive motion 60 minutes
Other: passive motion
The control group will follow a program of 18 sessions of physiotherapy and occupational therapy combined with 18 sessions of passive motion in flexion-elbow extension, wrist flexion-extension on the isokinetic device

  Eligibility

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

Inclusion Criteria:

  • Patients with more than 6 months post stroke,
  • Muscular control greater than or equal to 3 on the extensors and elbow flexors,
  • Muscular control greater than or equal to 3 on the flexors and extensors of the wrist,
  • Spasticity less than or equal to 3 on the muscle groups mentioned above, s
  • Active abduction of the shoulder above 60 ° and painless
  • Absence of cognitive impairment (MMS> 22 without any trouble phasic)
  • No orthopedic limitations at the elbow and wrist,

Exclusion Criteria:

  • Progressive neurological or systemic involvement,
  • Orthopedic limitations at the elbow or wrist
  • Cognitive,
  • Hemineglect,
  • Severe aphasia with impaired comprehension,
  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: NCT01554137

Contacts
Contact: Flavia COROIAN, MD 0467338717 f-coroian@chu-montpellier.fr

Locations
France
Service de médecine Physique et de Réadaptation Recruiting
Montpellier, France, 34000
Contact: Flavia COROIAN, MD    0467338717    f-coroian@chu-montpellier.fr   
Sub-Investigator: Isabelle LAFFONT, MD         
Sub-Investigator: Marc JULIA, MD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Flavia COROIAN, MD UH Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01554137     History of Changes
Other Study ID Numbers: 8571
Study First Received: March 12, 2012
Last Updated: April 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on October 23, 2014