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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-SC150251 | Other Grant/Funding Number | Congressionally Directed Medical Research Programs(CDMRP),Spinal Cord Injury Research Program, US Dept of Defense |
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| Name | Class |
|---|---|
| U.S. Army Medical Research Acquisition Activity | FED |
| United States Department of Defense | FED |
| Programs for Assessment of Technology in Health Research Institute | OTHER |
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A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, traumatic spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyndMove® therapy | Active Comparator | Non-invasive Functional Electrical Stimulation (FES) technique with surface electrodes to stimulate from 3 to 8 muscles to create purposeful movements in one or both hands/arms |
|
| Intensive Conventional therapy | Active Comparator | Using Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyndMove® | Device | This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy of MyndMove® therapy vs intensive conventional therapy in improving upper extremity function as measured by Spinal Cord Independence Measure self-care sub score (SCIM-SC) | SCIM-SC is a disability scale that has been specifically developed to evaluate the functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM-SC assesses function of self-care, which includes feeding, bathing, dressing and grooming. | Change from baseline to 6weeks to 14 weeks to 24weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP) | This is a multi-modality test designed to assess the integration of sensorimotor hand and upper limb impairment and function. This test combines the features of several other tests that have been used to assess hand and upper limb function in the peripheral hand population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Plymale | MyndTec Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center / Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio | 44109 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36188946 | Derived | Anderson KD, Korupolu R, Musselman KE, Pierce J, Wilson JR, Yozbatiran N, Desai N, Popovic MR, Thabane L. Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia. Front Rehabil Sci. 2022 Sep 9;3:995244. doi: 10.3389/fresc.2022.995244. eCollection 2022. | |
| 32988951 |
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| McMaster University |
| OTHER |
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial
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| Conventional Therapy | Other | Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed. |
|
| Change from baseline to 6weeks to 14weeks to 24weeks |
| Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT) | A test developed to evaluate improvements in the gross motor function of the unilateral grasp due to FES for reaching and grasping treatment. Hand functions that will be tested with the TRI-HFT are: lateral or pulp pinch, and palmar grasps. that have been used to assess hand and upper limb function in the peripheral hand population | Change from baseline to 14 weeks to 24weeks |
| To assess safety as measured by serious and non serious adverse events (SAEs) recorded for participants in both groups of the study population over the duration of the study | Duration of the trial from baseline to 24weeks |
| Change in quality of life as measured by the Spinal Cord Injury-Quality of Life (SCI-QOL) | The SCI-QOL measurement system is a multifaceted system of measuring patient reported outcomes across a wide variety of functioning specifically targeted for individuals with SCI | Change from baseline to 6weeks to 14weeks to 24weeks |
| TIRR Memorial Hermann |
| Houston |
| Texas |
| 77030 |
| United States |
| HealthTech Connex Centre for Neurology Studies / NeuroMotion Physiotherapy Clinics ( Surrey, Vancouver and Victoria) | Surrey | British Columbia | V3V 0C6 | Canada |
| Toronto Rehabilitation Institute | Toronto | Ontario | Canada |
| Anderson KD, Wilson JR, Korupolu R, Pierce J, Bowen JM, O'Reilly D, Kapadia N, Popovic MR, Thabane L, Musselman KE. Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study. BMJ Open. 2020 Sep 28;10(9):e039650. doi: 10.1136/bmjopen-2020-039650. |
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D020196 | Trauma, Nervous System |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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