Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
122 participants
INTERVENTIONAL
2021-07-29
2022-08-01
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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
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.
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.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Sheba Medical Center
OTHER_GOV
6Degrees LTD
INDUSTRY
Responsible Party
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Locations
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Sheba Medical Center'
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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202016500
Identifier Type: -
Identifier Source: org_study_id
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