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

NCT ID: NCT01010607

Last Updated: 2010-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-11-30

Brief Summary

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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

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Conditions

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Stroke Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vibraton Mirror (VM)

subjects will receive tendon vibration AND mirror therapy

Group Type EXPERIMENTAL

Vibration and Mirror

Intervention Type DEVICE

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 (M)

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

Group Type ACTIVE_COMPARATOR

Mirror therapy

Intervention Type DEVICE

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 (S)

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

Group Type SHAM_COMPARATOR

no mirror, sham vibration

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Organization

Locations

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Hadassah University Hospital

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Elior Moreh, MD

Role: CONTACT

97225844464

Facility Contacts

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Elior Moreh, MD

Role: primary

97225844464

References

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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. doi: 10.1093/brain/95.4.705. No abstract available.

Reference Type BACKGROUND
PMID: 4265060 (View on PubMed)

Dohle C, Pullen J, Nakaten A, Kust 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.

Reference Type RESULT
PMID: 19074686 (View on PubMed)

Other Identifiers

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0305-09-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id

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