Pain, Phantom
Conditions
Keywords
phantom limb pain, VAS, Telerehabilitation
Brief summary
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: 1. Tracking motion and movement kinematics. 2. 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
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).
Interventions
DEVICEMyMove/VR system
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.
DEVICEMirror therapy
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
Sponsors
Sheba Medical Center
6Degrees LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain change | 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Rehabilitation Recovery | 12 months | Demonstrate non-inferiority in comparison with existing treatments - change in range of motion over time. Angles measure from 0-120 degrees. |
Countries
Israel
Contacts
Primary ContactMiri Berger
Backup ContactAryeh H Katz
Outcome results
None listed