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

Primary Purpose

Stroke, Hemiplegia

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Vibration and Mirror
Mirror therapy
no mirror, sham vibration
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hadassah University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Vibraton Mirror (VM)

Mirror (M)

Sham (S)

Arm Description

subjects will receive tendon vibration AND mirror therapy

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

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

Outcomes

Primary Outcome Measures

Upper Limb function according to Fugl-Meyer assessment

Secondary Outcome Measures

Activity of Daily living performance assessed by FIM (Functional Independence Measurement) score

Full Information

First Posted
November 8, 2009
Last Updated
June 2, 2010
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01010607
Brief Title
Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction
Acronym
VibMirror
Official Title
Use of Tendon Vibration and Mirror for the Improvement of Upper Limb Function and Pain Reduction After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
November 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vibraton Mirror (VM)
Arm Type
Experimental
Arm Description
subjects will receive tendon vibration AND mirror therapy
Arm Title
Mirror (M)
Arm Type
Active Comparator
Arm Description
Subjects will receive treatment only with Mirror, together with sham vibration (over bone instead of tendon)
Arm Title
Sham (S)
Arm Type
Sham Comparator
Arm Description
Opaque board instead of mirror, bone vibration instead of tendon vibration
Intervention Type
Device
Intervention Name(s)
Vibration and Mirror
Intervention Description
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
Intervention Name(s)
Mirror therapy
Intervention Description
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
Intervention Name(s)
no mirror, sham vibration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Upper Limb function according to Fugl-Meyer assessment
Time Frame
after treatment, and 3 months after treatment
Secondary Outcome Measure Information:
Title
Activity of Daily living performance assessed by FIM (Functional Independence Measurement) score
Time Frame
after treatment and 3 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elior Moreh, MD
Phone
97225844464
Email
elior@hadassah.org.il
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elior Moreh, MD
Phone
97225844464
Email
elior@hadassah.org.il

12. IPD Sharing Statement

Citations:
PubMed Identifier
4265060
Citation
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.
Results Reference
background
PubMed Identifier
19074686
Citation
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.
Results Reference
result

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

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