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

Phase 1

• Conditions: Stroke; Hemiplegia
• Interventions: Device: Vibration and Mirror; Device: Mirror therapy; Device: no mirror, sham vibration

• Registration Number: NCT01010607
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2009-11-08
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Last Update Submitted: 2010-06-02
• Last Update Posted: 2010-06-03
• Primary Completion: 2010-12
• Study Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vibraton Mirror (VM)	Vibration and Mirror	subjects will receive tendon vibration AND mirror therapy
Mirror (M)	Mirror therapy	Subjects will receive treatment only with Mirror, together with sham vibration (over bone instead of tendon)
Sham (S)	no mirror, sham vibration	Opaque board instead of mirror, bone vibration instead of tendon vibration

Primary Outcome Measures

Name	Time	Method
Upper Limb function according to Fugl-Meyer assessment	after treatment, and 3 months after treatment

Secondary Outcome Measures

Name	Time	Method
Activity of Daily living performance assessed by FIM (Functional Independence Measurement) score	after treatment and 3 months after treatment

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel