Pain, PhantomNCT04955613
6Degrees VR System for Treatment of Phantom Limb Pain
A study testing MyMove/VR system and Mirror therapy in people with Pain, Phantom, run by 6Degrees LTD at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Phantom
- What is being tested?
- MyMove/VR system and Mirror therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteIsrael
- Study dates
- 29 Jul 2021to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center'
Ramat Gan, 52621
Israel Dudkevitch, Prof., +9720586503077, avi.avitan@sheba.health.gov.il
Avi Avitan, Dr., +9720586503077, avi.avitan@sheba.health.gov.il
About this study
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.
Read more
MyMove+ is a Physical Medicine and Rehabilitation software intended for use in upper extremity and full-body conventional rehabilitation by:
- Tracking motion and movement kinematics.
- 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.
Read the 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).
- Conditions
- Pain, Phantom
- Being tested
- MyMove/VR system, Mirror therapy
- Keywords
- phantom limb pain, VAS, Telerehabilitation
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyMove/VR systemDevice
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 therapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: MyMove/VR system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (1)
Physical Rehabilitation Recovery
Demonstrate non-inferiority in comparison with existing treatments - change in range of motion over time.
Angles measure from 0-120 degrees.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start29 Jul 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pain, PhantomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 6Degrees LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955613
- Sponsor's protocol ID
- 202016500
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is system-specific to the MyMove bands and can only be analyzed with embedded algorithm reference.
Publications
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.
PubMed 32482376Ziegler-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.
PubMed 18295618Sherman 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.
PubMed 6709380McCormick 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.
PubMed 24224475Ramachandran 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.
PubMed 8637922Weeks SR, Anderson-Barnes VC, Tsao JW. Phantom limb pain: theories and therapies. Neurologist. 2010 Sep;16(5):277-86. doi: 10.1097/NRL.0b013e3181edf128.
PubMed 20827116
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6Degrees VR System for Treatment of Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT04955613
- Acronym / sponsor ID
- 202016500
- Conditions
- Pain, Phantom
- Keywords
- phantom limb pain, VAS, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- 6Degrees LTDIndustry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Study start
- 29 Jul 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Tracking motion and movement kinematics.
- 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Device: Mirror therapy12 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 | Device: MyMove/VR systemsessions 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyMove/VR systemThe 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. | Device | MyMove/VR system |
| Mirror therapyMirror therapy or mirror visual feedback is a therapy for pain or disability that affects one side of the patient more than the other side | Device | Standard care |
Primary outcome
Pain change
Time frame: 12 months
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).
1 secondary outcome
Physical Rehabilitation Recovery
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Background: PubMed 32482376Hoffman 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.
- Background: PubMed 18295618Ziegler-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.
- Background: PubMed 6709380Sherman 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.
- Background: PubMed 24224475McCormick 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.
- Background: PubMed 8637922Ramachandran 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.
- Background: PubMed 20827116Weeks SR, Anderson-Barnes VC, Tsao JW. Phantom limb pain: theories and therapies. Neurologist. 2010 Sep;16(5):277-86. doi: 10.1097/NRL.0b013e3181edf128.
- Individual participant dataSharing planned: No. Data is system-specific to the MyMove bands and can only be analyzed with embedded algorithm reference.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyMove/VR system and Mirror therapy in people with Pain, Phantom, run by 6Degrees LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miri Berger (+9720522700352, mb@6degrees.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain change (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04955613, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.