NCT05128994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

April 5, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 5, 2024

Status Verified

August 1, 2024

Enrollment Period

2.3 years

First QC Date

October 19, 2021

Last Update Submit

August 1, 2024

Conditions

Spinal Cord Injuries

Keywords

spinal cord injuryfunctional electrical stimulationhand function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Quadriplegia Index of Function (QIF)

    At study completion, 10 weeks

  • Change in Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) after 10 weeks

    10 weeks

  • Psychosocial Impact of Assistive Devices Scale (PIADS)

    At study completion, 10 weeks

  • Change in Electromyography (EMG) signal metrics

    10 weeks

  • Number of serious adverse events

    10 weeks

Other Outcomes (2)

  • Setup time (minutes)

    10 Weeks

  • Canadian Occupational Performance Measure (COPM)

    Week 1, First session

Study Arms (1)

Non-invasive FES

EXPERIMENTAL

Wearable FES sleeve with non-invasive user controls

Device: User-controlled FES system

Interventions

User-controlled FES systemDEVICE

Wearable FES sleeve with non-invasive user controls

Non-invasive FES

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Battelle Memorial Institute

Columbus, Ohio, 43201, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • David A Friedenberg, PhD

    Battelle

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 22, 2021

Study Start

April 5, 2022

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

August 5, 2024

Record last verified: 2024-08

Locations

US(1)