Upper Extremity Functional Electrical Stimulation (FES) for Restoration of Upper Extremity Function After Spinal Cord Injury (SCI)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Spinal Cord Injuries
- Sponsor
- University of Miami
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Surface EMG
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
The purpose of this research is to examine the effects that functional electrical stimulation (FES) therapy has on the way the arms, brain and spinal cord work. The study team wants to understand what recovery looks like in persons with a spinal cord injury (SCI) or peripheral nerve injury (PNI) using the MyndMove (MyndTec Inc., Ontario, Canada) therapy system. This type of therapy uses stimulation to help people with SCI and other neurological conditions to perform common tasks, work out, or strengthen muscles.
Investigators
Matija Milosevic
Assistant Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •1\. Neurological Injury:
- •Traumatic spinal cord injury (SCI): neurological level at or above T1 spinal cord level; AIS A, B, C or D impairment grade
- •Group 1 (Acute SCI): Deemed medically stable by medical practitioner, less than 6 months post-injury.
- •Group 2 (Chronic SCI): More than 6 months post-injury.
- •Peripheral nerve injury (PNI), with or without SCI, who are pre- or post- upper extremity (UE) nerve transfer surgery
- •Group 3 (Acute Pre- or Post-UE nerve transfer surgery): Deemed medically stable and safe/appropriate to participate in MyndMove UE FES therapy intervention by referring neurosurgeon within 6 months pre- or post-UE nerve transfer surgery.
- •Group 4 (Chronic Post-UE nerve transfer surgery): Deemed medically stable and safe/appropriate to participate in MyndMove UE FES therapy intervention by referring neurosurgeon 6 months or more post-UE nerve transfer surgery.
- •3\. Has detectable residual connection in upper-limb muscles in at least one of the neurologically affected sides confirmed by a visible contraction when functional electrical stimulation (FES) is applied in at least one upper extremity muscle at baseline.
- •4\. Has detectable motor function in at least 1 upper extremity muscle on 1 neurologically affected side confirmed by voluntary electromyography (EMG) or detectable motor evoked potential (MEP) at the baseline assessment.
- •(Aim 2 only) Able to commit to intervention and assessment sessions over a maximum duration of 4 months.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Surface EMG
Time Frame: baseline 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)
Nine Hole Peg Test
Time Frame: baseline 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)
Graded-Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) Prehension Performance (GR-PP)
Time Frame: 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 FES
Time Frame: baseline, 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)