6Degrees VR System for Treatment of Phantom Limb Pain

NCT04955613 | Unknown DMC

• 1 other identifier: 202016500
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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. 1.Tracking motion and movement kinematics.
2. 2.Guiding patients in the performance of physical exercises according to the treating practitioner's guidelines.

Conditions

Pain, Phantom

Keywords

phantom limb pain; VAS; Telerehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Physical Rehabilitation Recovery

  12 months

Study Arms (2)

Standard care

ACTIVE COMPARATOR

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

MyMove/VR system

ACTIVE COMPARATOR

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

Interventions

MyMove/VR system DEVICE

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.

MyMove/VR system

Mirror therapy DEVICE

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

Standard care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 6Degrees LTD: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Sheba Medical Center'

Ramat Gan, 52621, Israel

RECRUITING

Related 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.

  PMID: 32482376 BACKGROUND

• 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.

  PMID: 18295618 BACKGROUND

• 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.

  PMID: 6709380 BACKGROUND

• 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.

  PMID: 24224475 BACKGROUND

• 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.

  PMID: 8637922 BACKGROUND

• 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.

  PMID: 20827116 BACKGROUND

MeSH Terms

Conditions

Phantom Limb

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Central Study Contacts

Miri Berger

CONTACT

+9720522700352; mb@6degrees.tech

Aryeh H Katz

CONTACT

+9720547796910; ar@6degrees.tech

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: July 9, 2021
• Study Start: July 29, 2021
• Primary Completion: April 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 9, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)