NCT04955613

6Degrees VR System for Treatment of Phantom Limb Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: 6Degrees LTD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Pain, Phantom

Interventions

Type	Name	Description
DEVICE	MyMove/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.
DEVICE	Mirror 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

Timeline

• Start date: 2021-07-29
• Primary completion: 2022-04-01
• Completion: 2022-08-01
• First posted: 2021-07-09
• Last updated: 2021-07-09

Locations

1 site across 1 country: Israel