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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01010607
First received: November 8, 2009
Last updated: June 2, 2010
Last verified: November 2009

November 8, 2009
June 2, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010607 on ClinicalTrials.gov Archive Site
Activity of Daily living performance assessed by FIM (Functional Independence Measurement) score [ Time Frame: after treatment and 3 months after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
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
Both
18 Years to 85 Years
Yes
Contact: Elior Moreh, MD 97225844464 elior@hadassah.org.il
Israel
 
NCT01010607
0305-09-HMO-CTIL
Not Provided
Elior Moreh/ MD, Hadassah Medical Organization
Hadassah Medical Organization
Not Provided
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