6Degrees VR System for Treatment of Phantom Limb Pain

Pain, Phantom Clinical Trial

Official title:

6Degrees VR System for Treatment of Phantom Limb Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955613
• Other study ID #: 202016500
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: May 2021
• Source: 6Degrees LTD
• Contact: Miri Berger
• Phone: +9720522700352
• Email: mb[@]6degrees.tech
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: August 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Phantom
• Phantom Limb

Intervention

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.
• 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

Locations

Country	Name	City	State
Israel	Sheba Medical Center'	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
6Degrees LTD	Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (6)

Hoffman HG, Boe DA, Rombokas E, Khadra C, LeMay S, Meyer WJ, Patterson S, Ballesteros A, Pitt SW. Virtual reality hand therapy: A new tool for nonopioid analgesia for acute procedural pain, hand rehabilitation, and VR embodiment therapy for phantom limb pain. J Hand Ther. 2020 Apr - Jun;33(2):254-262. doi: 10.1016/j.jht.2020.04.001. Epub 2020 May 30. — View Citation

McCormick Z, Chang-Chien G, Marshall B, Huang M, Harden RN. Phantom limb pain: a systematic neuroanatomical-based review of pharmacologic treatment. Pain Med. 2014 Feb;15(2):292-305. doi: 10.1111/pme.12283. Epub 2013 Nov 13. Review. — View Citation

Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. — View Citation

Sherman RA, Sherman CJ, Parker L. Chronic phantom and stump pain among American veterans: results of a survey. Pain. 1984 Jan;18(1):83-95. doi: 10.1016/0304-3959(84)90128-3. — View Citation

Weeks SR, Anderson-Barnes VC, Tsao JW. Phantom limb pain: theories and therapies. Neurologist. 2010 Sep;16(5):277-86. doi: 10.1097/NRL.0b013e3181edf128. Review. — View Citation

Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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