Spinal Cord InjuriesNCT05128994
Hand Grasp Function After Spinal Cord Injury
A study of Spinal Cord Injuries, run by Battelle Memorial Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Keep it Simple: A Broadly Usable, High-performance Grasp Orthotic
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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- User-controlled FES system
- Keywords
- spinal cord injury, functional electrical stimulation, hand function
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
User-controlled FES systemDevice
Wearable FES sleeve with non-invasive user controls
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive FES | Experimental | Wearable FES sleeve with non-invasive user controls Receives: Device: User-controlled FES system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Secondary outcomes (5)
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.
Measured: At study completion, 10 weeks
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
Measured: 10 weeks
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.
Measured: At study completion, 10 weeks
Change in Electromyography (EMG) signal metrics
Metrics derived from noninvasively recorded electromyography activity as the user attempts functional hand movements
Measured: 10 weeks
Number of serious adverse events
Assessed by number of incidences
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start5 Apr 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Battelle Memorial Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Sponsor
- Investigators
- David A Friedenberg, PhD, Principal investigator, Battelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128994
- Sponsor's protocol ID
- 100144033
- Status last verified
- Aug 2024
- First submitted
- 19 Oct 2021
- Last updated
- 5 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keep it Simple: A Broadly Usable, High-performance Grasp Orthotic
- ClinicalTrials.gov ID
- NCT05128994
- Acronym / sponsor ID
- 100144033
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, functional electrical stimulation, hand function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Battelle Memorial InstituteUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive FES | Experimental | Device: User-controlled FES systemWearable FES sleeve with non-invasive user controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| User-controlled FES systemWearable FES sleeve with non-invasive user controls | Device | Non-invasive FES |
Primary outcome
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
5 secondary outcomes
Quadriplegia Index of Function (QIF)
Time frame: At study completion, 10 weeks
Change in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) after 10 weeks
Time frame: 10 weeks
Psychosocial Impact of Assistive Devices Scale (PIADS)
Time frame: At study completion, 10 weeks
Change in Electromyography (EMG) signal metrics
Time frame: 10 weeks
Number of serious adverse events
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Friedenberg, PhD principal investigator
Battelle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Spinal Cord Injuries, run by Battelle Memorial Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of FES sleeve as a functional orthosis for activities of daily living (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.