6Degrees VR System for Treatment of Phantom Limb Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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6Degrees VR System for Treatment of Phantom Limb Pain

Conditions
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Pain, Phantom

Intervention / Treatment
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* Device: MyMove/VR system
* Device: Mirror therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>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. | Device: Mirror therapy<br>* 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<br>|
| Active Comparator: MyMove/VR system<br>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. | Device: MyMove/VR system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain change | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Rehabilitation Recovery | Demonstrate non-inferiority in comparison with existing treatments - change in range of motion over time. Angles measure from 0-120 degrees. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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phantom limb pain, VAS, Telerehabilitation