Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction
VibMirror
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 stroke
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 8, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedJune 3, 2010
November 1, 2009
1.1 years
November 8, 2009
June 2, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Upper Limb function according to Fugl-Meyer assessment
after treatment, and 3 months after treatment
Secondary Outcomes (1)
Activity of Daily living performance assessed by FIM (Functional Independence Measurement) score
after treatment and 3 months after treatment
Study Arms (3)
Vibraton Mirror (VM)
EXPERIMENTALsubjects will receive tendon vibration AND mirror therapy
Mirror (M)
ACTIVE COMPARATORSubjects will receive treatment only with Mirror, together with sham vibration (over bone instead of tendon)
Sham (S)
SHAM COMPARATOROpaque board instead of mirror, bone vibration instead of tendon vibration
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe cognitive impairment- severe Aphasia or severe Neglect that impair ability to understand instructions or to execute tasks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah University Hospital
Jerusalem, Israel
Related Publications (2)
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.
PMID: 4265060BACKGROUNDDohle 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.
PMID: 19074686RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 8, 2009
First Posted
November 10, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2010
Study Completion
November 1, 2011
Last Updated
June 3, 2010
Record last verified: 2009-11