6Degrees VR System for Treatment of Phantom Limb Pain

6Degrees

Status: Unknown

Conditions: Pain, Phantom

Treatments: Device: MyMove/VR system; Device: Mirror therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04955613

202016500

Details and patient eligibility

About

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.

Full 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).

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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.

Treatment:

Device: Mirror therapy

MyMove/VR system

Active Comparator group

Description:

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.

Treatment:

Device: MyMove/VR system