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Hand Grasp Function After Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
User-controlled FES system
Sponsored by
Battelle Memorial Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Spinal Cord Injuries focused on measuring spinal cord injury, functional electrical stimulation, hand function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Battelle Memorial InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-invasive FES

Arm Description

Wearable FES sleeve with non-invasive user controls

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
System Usability Scale (SUS)
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.
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
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.
Change in Electromyography (EMG) signal metrics
Metrics derived from noninvasively recorded electromyography activity as the user attempts functional hand movements
Number of serious adverse events
Assessed by number of incidences

Full Information

First Posted
October 19, 2021
Last Updated
April 6, 2022
Sponsor
Battelle Memorial Institute
Collaborators
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05128994
Brief Title
Hand Grasp Function After Spinal Cord Injury
Official Title
Keep it Simple: A Broadly Usable, High-performance Grasp Orthotic
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Battelle Memorial Institute
Collaborators
Ohio State University

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
spinal cord injury, functional electrical stimulation, hand function

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-invasive FES
Arm Type
Experimental
Arm Description
Wearable FES sleeve with non-invasive user controls
Intervention Type
Device
Intervention Name(s)
User-controlled FES system
Intervention Description
Wearable FES sleeve with non-invasive user controls
Primary Outcome Measure Information:
Title
Feasibility of FES sleeve as a functional orthosis for activities of daily living
Description
Semi structured interviews will involve gaining participants opinions on the strengths and weaknesses of the system
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Quadriplegia Index of Function (QIF)
Description
Self-report tool assessing 37 activities of daily living with each task scored from 0 to 4 in order of increasing independence.
Time Frame
At study completion, 10 weeks
Title
System Usability Scale (SUS)
Description
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.
Time Frame
At study completion, 10 weeks
Title
Change in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) after 10 weeks
Description
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
Time Frame
10 weeks
Title
Psychosocial Impact of Assistive Devices Scale (PIADS)
Description
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.
Time Frame
At study completion, 10 weeks
Title
Change in Electromyography (EMG) signal metrics
Description
Metrics derived from noninvasively recorded electromyography activity as the user attempts functional hand movements
Time Frame
10 weeks
Title
Number of serious adverse events
Description
Assessed by number of incidences
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Setup time (minutes)
Description
The time it takes to physically don, connect, and calibrate system components
Time Frame
10 Weeks
Title
Canadian Occupational Performance Measure (COPM)
Description
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.
Time Frame
Week 1, First session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Wengerd, PhD, OTR/L
Phone
330-464-9171
Email
Lauren.wengerd@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Sunderman, MS
Phone
614-915-7814
Email
sunderman@battelle.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A Friedenberg, PhD
Organizational Affiliation
Battelle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Battelle Memorial Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Sunderman, MS
Phone
614-915-7814
Email
sunderman@battelle.org
First Name & Middle Initial & Last Name & Degree
David A Friedenberg, PhD

12. IPD Sharing Statement

Learn more about this trial

Hand Grasp Function After Spinal Cord Injury

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