6Degrees VR System for Treatment of Phantom Limb Pain

June 29, 2021 updated by: 6Degrees LTD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard care

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
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
ACTIVE_COMPARATOR: MyMove/VR system

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain change
Time Frame: 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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Rehabilitation Recovery
Time Frame: 12 months

Demonstrate non-inferiority in comparison with existing treatments - change in range of motion over time.

Angles measure from 0-120 degrees.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

6Degrees LTD

Collaborators

Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 29, 2021

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (ACTUAL)

July 9, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202016500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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