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

Stroke Clinical Trial

— VibMirror  

Official title:

Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction After Stroke

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01010607
• Other study ID #: 0305-09-HMO-CTIL
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: November 8, 2009
• Last updated: June 2, 2010
• Start date: November 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2009
• Source: Hadassah Medical Organization
• Contact: Elior Moreh, MD
• Phone: 97225844464
• Email: elior[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Israel	Hadassah University Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Dohle C, Püllen J, Nakaten A, Küst J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12. — View Citation

Goodwin GM, McCloskey DI, Matthews PB. The contribution of muscle afferents to kinaesthesia shown by vibration induced illusions of movement and by the effects of paralysing joint afferents. Brain. 1972;95(4):705-48. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper Limb function according to Fugl-Meyer assessment		after treatment, and 3 months after treatment	No
Secondary	Activity of Daily living performance assessed by FIM (Functional Independence Measurement) score		after treatment and 3 months after treatment	No