Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction (VibMirror)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01010607|
Recruitment Status : Unknown
Verified November 2009 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : November 10, 2009
Last Update Posted : June 3, 2010
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 or disease||Intervention/treatment||Phase|
|Stroke Hemiplegia||Device: Vibration and Mirror Device: Mirror therapy Device: no mirror, sham vibration||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction After Stroke|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||November 2011|
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.
- Upper Limb function according to Fugl-Meyer assessment [ Time Frame: after treatment, and 3 months after treatment ]
- Activity of Daily living performance assessed by FIM (Functional Independence Measurement) score [ Time Frame: after treatment and 3 months after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010607
|Contact: Elior Moreh, MDfirstname.lastname@example.org|
|Hadassah University Hospital||Not yet recruiting|
|Contact: Elior Moreh, MD 97225844464 email@example.com|