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Clinical Trials/NCT01010607
NCT01010607UnknownPhase 1

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

Hadassah Medical Organization1 site in 1 country30 target enrollmentStarted: November 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Enrollment
30
Locations
1
Primary Endpoint
Upper Limb function according to Fugl-Meyer assessment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Vibraton Mirror (VM)

Experimental

subjects will receive tendon vibration AND mirror therapy

Intervention: Vibration and Mirror (Device)

Mirror (M)

Active Comparator

Subjects will receive treatment only with Mirror, together with sham vibration (over bone instead of tendon)

Intervention: Mirror therapy (Device)

Sham (S)

Sham Comparator

Opaque board instead of mirror, bone vibration instead of tendon vibration

Intervention: no mirror, sham vibration (Device)

Outcomes

Primary Outcomes

Upper Limb function according to Fugl-Meyer assessment

Time Frame: after treatment, and 3 months after treatment

Secondary Outcomes

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

Investigators

Sponsor Class
Other

Study Sites (1)

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