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
  Purpose

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.


Condition Intervention Phase
Stroke
Hemiplegia
Device: Vibration and Mirror
Device: Mirror therapy
Device: no mirror, sham vibration
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction After Stroke

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Upper Limb function according to Fugl-Meyer assessment [ Time Frame: after treatment, and 3 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vibraton Mirror (VM)
subjects will receive tendon vibration AND mirror therapy
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.
Active Comparator: Mirror (M)
Subjects will receive treatment only with Mirror, together with sham vibration (over bone instead of tendon)
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.
Sham Comparator: Sham (S)
Opaque board instead of mirror, bone vibration instead of tendon vibration
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01010607

Contacts
Contact: Elior Moreh, MD 97225844464 elior@hadassah.org.il

Locations
Israel
Hadassah University Hospital Not yet recruiting
Jerusalem, Israel
Contact: Elior Moreh, MD    97225844464    elior@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Elior Moreh/ MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01010607     History of Changes
Other Study ID Numbers: 0305-09-HMO-CTIL
Study First Received: November 8, 2009
Last Updated: June 2, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hemiplegia
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014