University of Miami - Miami Project to Cure Paralysis
Miami, Florida, 33136, United States
Location status: Recruiting
Location contact
Deena Cilien, DPT
CONTACT
Matija Milosevic, PhD
CONTACT
Matija Milosevic, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06672458
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Miami, Florida, 33136, United States
Location status: Recruiting
Deena Cilien, DPT
CONTACT
Matija Milosevic, PhD
CONTACT
Matija Milosevic, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
or
Exclusion criteria
FES therapy will be provided in one visit (one hour duration) delivered within a 2 week period, in person. FES therapy uses surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements the single use electrodes will be placed in various combinations on the surface of the different upper arm muscles. Participants will perform hand and finger dexterity tests as well as arm functional mobility tasks while receiving FES.
Therapy will be provided in one visit (one hour duration) delivered within a 2 week period, in person. Conventional therapy will consist of performance hand and finger dexterity tests as well as arm functional mobility tasks
FES upper arm therapy will be provided in one-hour in-person sessions for a maximum of 40 sessions delivered no less than 3 times per week and up to 5 times per week during a period of up to 12 weeks. Over the course of 40 sessions, participants will progress through various movement sequences aimed at regaining natural, unassisted voluntary movements in the affected arms while receiving FES.
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)
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)
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)
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)
Contact information is provided by the study sponsor or research team.
Cristina Thurston, DPT
CONTACT
Deena Cilien, DPT
CONTACT
University of Miami
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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