Upper Extremity FES for Spinal Cord Injury
This study is looking at how a treatment called MyndMove Functional Electrical Stimulation (FES) therapy affects arm movement, the brain, and spinal cord in people with spinal cord injuries (SCI) or peripheral nerve injuries (PNI). MyndMove uses gentle electrical pulses to help muscles contract, which can improve reaching and grasping. You might receive MyndMove therapy for a short time (one hour within two weeks) or for a longer period (up to 40 one-hour sessions over 12 weeks). Some participants will receive conventional therapy instead. Researchers will measure your hand and arm function using tests like the Nine Hole Peg Test and GRASSP Prehension Performance to see if the treatments help. This study is for adults aged 18 to 70 with a spinal cord injury at or above the T1 level, or a peripheral nerve injury. The study is currently unclear on its recruitment status and plans to enroll 60 participants.
- Study design
- This interventional study plans to enroll 60 participants. It compares MyndMove FES therapy to conventional therapy.
- What's involved
- You would have in-person therapy sessions, either one hour within two weeks, or up to 40 one-hour sessions over 12 weeks. You will also complete hand and arm function tests at the start and at various points up to 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your hand and arm function will be measured at baseline, up to 2 weeks, and at 12 weeks after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Matija Milosevic, PhD · PRINCIPAL_INVESTIGATOR · University of Miami
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Nine Hole Peg Testbaseline and up to 2 weeks
The Nine-Hole Peg Test assesses hand and finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container. Test is performed at the beginning and end of each intervention visit. Scores are based on the time taken to complete the activity, recorded in seconds. (Only for subjects in short term intervention)
- Surface EMGbaseline and up to 2 weeks
EMG signals (measured in volts) recorded by skin surface EMG electrodes placed on the arm(s) during muscle contraction to evaluate muscle activity and motor unit activity at the beginning and end of each intervention visit. (Only for subjects in short term intervention)
- Graded-Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Prehension Performance (GR-PP)baseline, 12 weeks
GRASSP test will be used to assess upper arm motor function. Series of tasks will test subject's strength, sensation, and prehension. The prehension ability sub-test is scored for a total max score of 30 for each arm, using a scale from 0-30 where 0 is no upper arm motor function and 30 is full upper arm motor function. (Only for subjects in long term intervention)
- Manual Muscle Test (MMT) with FESbaseline, 12 weeks
A test that measures muscle strength and function with FES via MyndMove. Each muscle group tested (varies) will be scored from 0-5, where 0 is indicating no movement and strength and a max score of 5 indicating full, normal movement and strength. (Only for subjects in long term intervention)