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Hand Grasp Function After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05128994
Recruitment Status : Recruiting
First Posted : November 22, 2021
Last Update Posted : April 7, 2022
Sponsor:
Collaborator:
Ohio State University
Information provided by (Responsible Party):
Battelle Memorial Institute

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: User-controlled FES system Not Applicable

Detailed Description:

Battelle has developed a novel wearable sleeve that can reanimate a paralyzed limb via Functional Electrical Stimulation (FES) that is controlled non-invasively by the user. Previous work has shown the ability of this sleeve and FES technology to significantly enhance independence and quality of life when controlled by an implanted brain-computer interface, thus now investigators plan to trial use of the high-definition FES system with simpler, non-invasive control mechanisms to expedite translation of this technology into real-world settings. Each participant will complete up to 10 research sessions (~1.5hrs each) in their residence or at an alternative location. The study location is restricted to Columbus Ohio and surrounding areas. Participants will be compensated for their time.

In Aim 1, investigators will evaluate the ability of a non-invasive, user-controlled FES system to increase functional hand use in the homes of individuals with SCI. The research team will train participants to use the FES system for different functional hand movements and activities they identify as important to them, then measure FES system effectiveness using standardized assessments.

In Aim 2, investigators will assess the viability of using the sleeve technology to non-invasively record muscle activity as the participant attempts different functional movements.

In Aim 3, human-centric design methodology and contextual inquiry interviews will be employed to understand study participants' needs and preferences for a FES assistive device. This information will determine actions to improve usability and optimize the system for unsupervised home use.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Keep it Simple: A Broadly Usable, High-performance Grasp Orthotic
Actual Study Start Date : April 5, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-invasive FES
Wearable FES sleeve with non-invasive user controls
 Device: User-controlled FES system
Wearable FES sleeve with non-invasive user controls


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of FES sleeve as a functional orthosis for activities of daily living [ Time Frame: 10 weeks ]
    Semi structured interviews will involve gaining participants opinions on the strengths and weaknesses of the system


Secondary Outcome Measures :
  1. Quadriplegia Index of Function (QIF) [ Time Frame: At study completion, 10 weeks ]
    Self-report tool assessing 37 activities of daily living with each task scored from 0 to 4 in order of increasing independence.

  2. System Usability Scale (SUS) [ Time Frame: At study completion, 10 weeks ]
    Questionnaire composed of 10 statements that are scored on a 5-point scale of strength agreement from strongly disagree to strongly agree. The questionnaire is designed to assess the overall usability of a system or product.

  3. Change in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) after 10 weeks [ Time Frame: 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

  4. Psychosocial Impact of Assistive Devices Scale (PIADS) [ Time Frame: At study completion, 10 weeks ]
    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.

  5. Change in Electromyography (EMG) signal metrics [ Time Frame: 10 weeks ]
    Metrics derived from noninvasively recorded electromyography activity as the user attempts functional hand movements

  6. Number of serious adverse events [ Time Frame: 10 weeks ]
    Assessed by number of incidences


Other Outcome Measures:
  1. Setup time (minutes) [ Time Frame: 10 Weeks ]
    The time it takes to physically don, connect, and calibrate system components

  2. Canadian Occupational Performance Measure (COPM) [ Time Frame: Week 1, First session ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05128994


Contacts
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Contact: Lauren Wengerd, PhD, OTR/L 330-464-9171 Lauren.wengerd@osumc.edu
Contact: Michelle Sunderman, MS 614-915-7814 sunderman@battelle.org

Locations
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United States, Ohio
Battelle Memorial Institute Recruiting
Columbus, Ohio, United States, 43201
Contact: Michelle Sunderman, MS    614-915-7814    sunderman@battelle.org   
Principal Investigator: David A Friedenberg, PhD         
Sponsors and Collaborators
Battelle Memorial Institute
Ohio State University
Investigators
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Principal Investigator: David A Friedenberg, PhD Battelle
More Information
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Responsible Party: Battelle Memorial Institute
ClinicalTrials.gov Identifier: NCT05128994    
Other Study ID Numbers: 100144033
First Posted: November 22, 2021    Key Record Dates
Last Update Posted: April 7, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Battelle Memorial Institute:
spinal cord injury
functional electrical stimulation
hand function
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System