Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction (VibMirror)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010607
Recruitment Status : Unknown
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : November 10, 2009
Last Update Posted : June 3, 2010
Information provided by:
Hadassah Medical Organization

November 8, 2009
November 10, 2009
June 3, 2010
November 2009
December 2010   (Final data collection date for primary outcome measure)
Upper Limb function according to Fugl-Meyer assessment [ Time Frame: after treatment, and 3 months after treatment ]
Same as current
Complete list of historical versions of study NCT01010607 on Archive Site
Activity of Daily living performance assessed by FIM (Functional Independence Measurement) score [ Time Frame: after treatment and 3 months after treatment ]
Same as current
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Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction
Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction After Stroke

Upper limb paralysis following stroke is a very common problem. Only 30% of stroke patients who suffer from upper limb paresis experience a full recovery of function. There is a need for the development of more efficient rehabilitation methods for the improvement of the paralysed upper limb function.

It has been shown that the use of mirror therapy after a stroke induces the activation of motor, sensory and associative regions in the affected hemisphere and is associated with an improvement in the function of the affected limb. Mirror therapy is a treatment modality in which the affected arm is hidden from the patient's sight; the patient is instructed to watch the reflection of his healthy hand on a mirror while he performs movements with his healthy hand and tries to move simultaneously his affected hand. This induces the illusion that his affected hand moves well.

It has also been shown that applying vibration to a muscle tendon at frequencies between 50-100 Hz induces an illusion of elongation of the vibrated muscle, if visual feedback is prevented. For instance, vibrating the triceps will induce a strong illusion of elbow flexion.

In the present study the investigators will couple the use of a mirror with the application of vibration to tendons, in order to obtain a multisensorial and strong illusion of movement in the paralyzed limb.

The study hypothesis is that the administration of mirror therapy together with vibration will induce the activation of multiple motor, sensory and associative areas in the affected brain hemisphere, resulting in improvement of the affected upper limb function, compared to the administration of mirror therapy alone or sham therapy.

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Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Stroke
  • Hemiplegia
  • Device: Vibration and Mirror
    10 treatments of 30 minutes in which vibration of 50-100 Hz will be administrated to the elbow and wrist muscles together with the use of a mirror. The patient moves his healthy hand in a certain repetitive pattern and watches its reflection on a mirror. Meanwhile he receives vibration in his affected hand in a timing that induces the illusion of movements similar to the movements of his healthy hand, thereby inducing a strong illusion of movement of his affected hand.
  • Device: Mirror therapy
    10 sessions of mirror therapy: moving the healthy hand while watching its reflection on a mirror. Meanwhile sham vibration over bone in the affected handwill be given to resemble the conditions of the experimental arm.
  • Device: no mirror, sham vibration
    10 sessions in which patient moves his healthy hand and tries to move his affected hand, which is hidden by an opaque board instead of a mirror. Sham vibration is applied to bone instead of muscle, no illusion is generated.
  • Experimental: Vibraton Mirror (VM)
    subjects will receive tendon vibration AND mirror therapy
    Intervention: Device: Vibration and Mirror
  • Active Comparator: Mirror (M)
    Subjects will receive treatment only with Mirror, together with sham vibration (over bone instead of tendon)
    Intervention: Device: Mirror therapy
  • Sham Comparator: Sham (S)
    Opaque board instead of mirror, bone vibration instead of tendon vibration
    Intervention: Device: no mirror, sham vibration

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
November 2011
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Stroke onset 1 month-1 year ago
  • NIH Stroke Scale 3-15 on admission to study
  • Affected Upper limb function 10-90% on Fugl-Meyer scale
  • Ability to understand instructions and to move freely the unaffected upper limb

Exclusion Criteria:

  • Severe cognitive impairment- severe Aphasia or severe Neglect that impair ability to understand instructions or to execute tasks
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Elior Moreh/ MD, Hadassah Medical Organization
Hadassah Medical Organization
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Not Provided
Hadassah Medical Organization
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP