Hand Grasp Function After Spinal Cord Injury
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.
Conditions:
🦠 Spinal Cord Injuries
🗓️ Study Start (Actual) 5 April 2022
🗓️ Primary Completion (Estimated) July 2024
✅ Study Completion (Estimated) July 2024
👥 Enrollment (Estimated) 8
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Columbus, Ohio, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 October 2021
  • First Submitted that Met QC Criteria 10 November 2021
  • First Posted 22 November 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 April 2024
  • Last Update Posted 9 April 2024
  • Last Verified April 2024