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Interests of Strengthening Isokinetic Upper Extremity Hemiparetic Sequelae in Patients

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ClinicalTrials.gov Identifier: NCT01554137
Recruitment Status : Terminated
First Posted : March 14, 2012
Last Update Posted : June 1, 2016
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

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 or disease Intervention/treatment
Partial Deficiency of Muscle Strength Other: isokinetic strength training Other: passive motion

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Interests of Strengthening Isokinetic Upper Extremity Hemiparetic Sequelae in Patients
Study Start Date : October 2010
Primary Completion Date : October 2015
Study Completion Date : October 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. upper limb motor function [ Time Frame: 6 weeks ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554137

Service de médecine Physique et de Réadaptation
Montpellier, France, 34000
Sponsors and Collaborators
University Hospital, Montpellier
Principal Investigator: Flavia COROIAN, MD UH Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01554137     History of Changes
Other Study ID Numbers: 8571
First Posted: March 14, 2012    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016