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.

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).

A non-blinded controlled study of adults. Each patient admitted to the study will be randomly allocated to either the treatment or control group (provided standard care) in consecutive order.

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.

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.

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

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).

Demonstrate non-inferiority in comparison with existing treatments - change in range of motion over time. Angles measure from 0-120 degrees.

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.

Data is system-specific to the MyMove bands and can only be analyzed with embedded algorithm reference.

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