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TerminatedNCT01554137Updated Jun 1, 2016

Interests of Strengthening Isokinetic Upper Extremity Hemiparetic Sequelae in Patients

An interventional study of isokinetic strength training and passive motion in Partial Deficiency of Muscle Strength, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-01.

Sponsored by University Hospital, Montpellier · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Partial Deficiency of Muscle Strength
03

In context

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Progressive neurological or systemic involvement,
  • Orthopedic limitations at the elbow or wrist
  • Cognitive,
  • Hemineglect,
  • Severe aphasia with impaired comprehension,
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    With isokinetic strength training

    60 minutes isokinetic strength training on concentric mode

    Other: isokinetic strength training

  • Placebo comparator
    without isokinetic strength training

    passive motion 60 minutes

    Other: passive motion

Interventions

  • Otherisokinetic 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.

  • Otherpassive 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

06

What researchers measure

Primary outcomes

  1. upper limb motor function

    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.

    Time frame: 6 weeks

07

Study locations

1 site
  • Service de médecine Physique et de Réadaptation
    Montpellier, 34000, France
08

References and documents

Publications

  • Coroian F, Jourdan C, Bakhti K, Palayer C, Jaussent A, Picot MC, Mottet D, Julia M, Bonnin HY, Laffont I. Upper Limb Isokinetic Strengthening Versus Passive Mobilization in Patients With Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):321-328. doi: 10.1016/j.apmr.2017.08.490. Epub 2017 Sep 22. PubMed 28947166 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01554137
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Mar 14, 2012
Start date
Oct 2010
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Jun 1, 2016

Study contacts

Flavia COROIAN, MD
principal investigator · UH Montpellier

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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