Clinical trial NCT04955613: 6Degrees VR System for Treatment of Phantom Limb Pain
Official title: 6Degrees VR System for Treatment of Phantom Limb Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Phantom
Keywords: phantom limb pain
VAS
Telerehabilitation
Lead sponsor: 6Degrees LTD
Sponsor class: INDUSTRY
Collaborators: name: Sheba Medical Center
First posted: 2021-07-09
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Pain change
timeFrame: 12 months
Secondary outcomes:
measure: Physical Rehabilitation Recovery
timeFrame: 12 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center'
Study officials:
References:
citation: 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.
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.
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.
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.
citation: Ramachandran VS, Rogers-Ramachandran D. Synaesthesia in phantom limbs induced with mirrors. Proc Biol Sci. 1996 Apr 22;263(1369):377-86. doi: 10.1098/rspb.1996.0058.
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.