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| Name | Class |
|---|---|
| Sheba Medical Center | OTHER_GOV |
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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:
MyMove+ software is not intended for use in diagnosis, treatment or decision-making, or as a stand-alone device.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miri Berger | Contact | +9720522700352 | mb@6degrees.tech | |
| Aryeh H Katz | Contact | +9720547796910 | ar@6degrees.tech |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center' | Recruiting | Ramat Gan | 52621 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32482376 | Background | 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. | |
| 18295618 |
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Data is system-specific to the MyMove bands and can only be analyzed with embedded algorithm reference.
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| ID | Term |
|---|---|
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000088762 | Mirror Movement Therapy |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
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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.
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|
| 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 |
|
| 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. |
| 6709380 | 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. |
| 24224475 | 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. |
| 8637922 | 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. |
| 20827116 | 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. |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010146 | Pain |