An interventional study of MyndMove® and Conventional Therapy in Spinal Cord Injuries and Trauma, Nervous System, sponsored by MyndTec Inc.. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by MyndTec Inc. · Not applicable, Interventional, and Treatment
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's enrollment of 51 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →MyndTec Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: MyndMove®
Using Conventional therapy which focuses exclusively on the purposeful movements in one or both hands/arms
Other: Conventional Therapy
This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function
Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.
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.
Time frame: Change from baseline to 6weeks to 14 weeks to 24weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 6weeks to 14weeks to 24weeks
Plan to share: No
Ran from Jun 2019 to primary completion in Feb 2022, 32 months.
Of 49 industry-sponsored interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's 32 months is above that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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MyndTec Inc.