Hand Grasp Function After Spinal Cord Injury

Completed · Not applicable

Conditions studied: Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT05128994

Run by

Battelle Memorial Institute

People needed

5

Starts

2022-04-05

Expected to finish

2024-07-31

Last updated by the study team

2024-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Battelle Memorial Institute — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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