Spinal Cord Injuries Clinical Trial
Official title:
Keep it Simple: A Broadly Usable, High-performance Grasp Orthotic
NCT number | NCT05128994 |
Other study ID # | 100144033 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 5, 2022 |
Est. completion date | July 2024 |
The objective of this study is to advance personalized, portable, and non-invasive hand-grasp neuro-orthoses that restore naturalistic grasp functions for those with tetraplegia due to spinal cord injury (SCI), designed around their needs and preferences.
Status | Recruiting |
Enrollment | 8 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - = 18 years old - = 12 months post-SCI and medically/neurologically stable - Cervical spinal cord injury (C1-C8); any etiology except neurodegenerative conditions - Unable to grasp objects independently with both hands (tetraplegia) - Manual muscle testing (MMT) scores =4/5 for elbow flexion and =2/5 for wrist extension - Willing to participate in sessions at home or able to travel to alternate site for study sessions Exclusion Criteria: - Ventilator-dependent (dependent upon mechanical life support due to inability to breathe effectively) - Poorly controlled autonomic dysreflexia (more than one episode in 3 months prior to enrollment) - Moderate to severe spasticity (Modified Ashworth Scale (MAS) >1+) in the hand, wrist, or forearm - Received a localized injection (e.g. Botox) to hand, wrist, or forearm muscles within past 12 months - Currently participating in physical rehabilitation for upper extremity impairments - Individuals having or requiring any of the following: implanted pacemaker, life supporting/sustaining equipment, or critical non-removable implantable electronic devices such as an insulin pump or neurostimulator. - Presence of any other clinically significant medical comorbidity and/or neurological condition for which participation in the study may pose a safety risk and/or influence results - Presence of the following medical conditions: uncontrolled seizure disorder, active malignancy in the upper extremities, or open wounds/infections in the upper extremities - Individuals whose forearm is determined to be too small or too large to fit the electrode sleeve being investigated - Individuals who are pregnant or plan to get pregnant during the course of the study |
Country | Name | City | State |
---|---|---|---|
United States | Battelle Memorial Institute | Columbus | Ohio |
Lead Sponsor | Collaborator |
---|---|
Battelle Memorial Institute | Ohio State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Setup time (minutes) | The time it takes to physically don, connect, and calibrate system components | 10 Weeks | |
Other | Canadian Occupational Performance Measure (COPM) | A 9 item assessment to measure perceived occupational performance of self-care, productivity and leisure. COPM uses semi-structured interview questions to identify activities that the individuals wants, needs or is expected to perform. | Week 1, First session | |
Primary | Feasibility of FES sleeve as a functional orthosis for activities of daily living | Semi structured interviews will involve gaining participants opinions on the strengths and weaknesses of the system | 10 weeks | |
Secondary | Quadriplegia Index of Function (QIF) | Self-report tool assessing 37 activities of daily living with each task scored from 0 to 4 in order of increasing independence. | At study completion, 10 weeks | |
Secondary | Change in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) after 10 weeks | Standardized test will assess participant's ability to perform complex grasp tasks: pouring a bottle; opening lids on two sizes of jars; inserting/turning key in lock; manipulating pegs in a pegboard; inserting four sizes of coins into slots; and screwing four sizes of nuts onto bolts | 10 weeks | |
Secondary | Psychosocial Impact of Assistive Devices Scale (PIADS) | Assesses user opinions of assistive devices across 26 items, describing likelihood of device adoption for regular use and psychosocial effects of use on function independence, well-being, and quality of life. Each item is scored on a 7 point Likert Scale from -3 to 3 with higher scores indicating more positive impact. | At study completion, 10 weeks | |
Secondary | Change in Electromyography (EMG) signal metrics | Metrics derived from noninvasively recorded electromyography activity as the user attempts functional hand movements | 10 weeks | |
Secondary | Number of serious adverse events | Assessed by number of incidences | 10 weeks |
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