6Degrees VR System for Treatment of Phantom Limb Pain
The treatment system consists of two light-weight MyMove bands and virtual-reality gear. Built-in software allows tracking of performance in real-time, with feedback to both the patient and treating personnel.
MyMove is a wearable device that allows patients with loss of upper-limb function to operate computers, cellular phones, and similar devices. The technology is non-invasive and does not involve risk to the patient.
MyMove+ is a Physical Medicine and Rehabilitation software intended for use in upper extremity and full-body conventional rehabilitation by:
- Tracking motion and movement kinematics.
- Guiding patients in the performance of physical exercises according to the treating practitioner's guidelines.
MyMove+ software is not intended for use in diagnosis, treatment or decision-making, or as a stand-alone device.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A non-blinded controlled study of adults, ages 18-65, with unilateral, below-knee limb amputation.
All subjects will be initially evaluated by a single group of licensed physical- and occupational therapists. Following a structured introductory session, subjects will be assigned to MyMove devices and VR gear for a total of 10 sessions over a period of 5 weeks (15-20 minutes per session).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Miri Berger
- Phone Number: +9720522700352
- Email: mb@6degrees.tech
Study Contact Backup
- Name: Aryeh H Katz
- Phone Number: +9720547796910
- Email: ar@6degrees.tech
Study Locations
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Ramat Gan, Israel, 52621
- Recruiting
- Sheba Medical Center'
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Contact:
- Israel Dudkevitch, Prof.
- Phone Number: +9720586503077
- Email: avi.avitan@sheba.health.gov.il
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Contact:
- Avi Avitan, Dr.
- Phone Number: +9720586503077
- Email: avi.avitan@sheba.health.gov.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clearance by the treating physician.
- Unilateral below-knee amputation
- History of phantom-limb pain with an intensity of 5-or-greater (VAS scale)
- Pain is not responsive to conventional drugs or other standard treatment.
- Range of motion (knee) of 10-to-90 degrees.
Exclusion Criteria:
- Bilateral amputation
- History of phantom-limb pain with an intensity of 4-or-less (VAS scale)
- No prior attempt at therapy
- Declined by patient
- Pregnancy or other limitation related to special health-care groups.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Standard care
12 sessions in total: sessions 1: Meeting with a doctor and physical therapist. sessions 2-11:Mirror therapy (standard care) for a total of 10 sessions over a period of 5 weeks (15-20 minutes per session). sessions 12: Meeting with a doctor and physical therapist. |
Mirror therapy or mirror visual feedback is a therapy for pain or disability that affects one side of the patient more than the other side
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ACTIVE_COMPARATOR: MyMove/VR system
sessions 1: Meeting with a doctor and physical therapist. sessions 2-11:MyMove devices and VR gear for a total of 10 sessions over a period of 5 weeks 15-20 minutes per session. sessions 12: Meeting with a doctor and physical therapist. |
The treatment system consists of two lightweight MyMove bands and Virtual-Reality (VR) gear. Proprietary software and content allow tracking of performance in real-time, with feedback to both the patient and treating - personnel. MyMove is a wearable device that allows patients with loss of upper limb function to operate computers, cellular phones, and similar devices. The technology is non-invasive and does not involve risk to the patient. Virtual-Reality (VR) gear is a wearable computer running within goggles that project content and allow for interaction using controllers. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain change
Time Frame: 12 months
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Demonstrate non-inferiority in comparison with existing treatments - change pain level by at least two visual analog scale (VAS) levels. VAS scale runs from 0 (pain-free) to 10 (extreme pain). |
12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Rehabilitation Recovery
Time Frame: 12 months
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Demonstrate non-inferiority in comparison with existing treatments - change in range of motion over time. Angles measure from 0-120 degrees. |
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Sherman RA, Sherman CJ, Parker L. Chronic phantom and stump pain among American veterans: results of a survey. Pain. 1984 Jan;18(1):83-95. doi: 10.1016/0304-3959(84)90128-3.
- Hoffman HG, Boe DA, Rombokas E, Khadra C, LeMay S, Meyer WJ, Patterson S, Ballesteros A, Pitt SW. Virtual reality hand therapy: A new tool for nonopioid analgesia for acute procedural pain, hand rehabilitation, and VR embodiment therapy for phantom limb pain. J Hand Ther. 2020 Apr-Jun;33(2):254-262. doi: 10.1016/j.jht.2020.04.001. Epub 2020 May 30.
- Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
- McCormick Z, Chang-Chien G, Marshall B, Huang M, Harden RN. Phantom limb pain: a systematic neuroanatomical-based review of pharmacologic treatment. Pain Med. 2014 Feb;15(2):292-305. doi: 10.1111/pme.12283. Epub 2013 Nov 13.
- Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. doi: 10.1098/rspb.1996.0058.
- Weeks SR, Anderson-Barnes VC, Tsao JW. Phantom limb pain: theories and therapies. Neurologist. 2010 Sep;16(5):277-86. doi: 10.1097/NRL.0b013e3181edf128.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202016500
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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