N/A
N=5
Neural Adaptation After Tendon Transfer and Training in Tetraplegia
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02768103 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Pinch Force — 8.7; 10.6 newtons
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- task-based training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pinch Force |
8.7; 10.6 | — |
| PRIMARY Functional MRI BOLD Signal From Motor Cortex |
— | — |
| SECONDARY Fine-wire Electromyography of Transferred Brachioradialis Muscle (to Paralyzed Thumb Flexor) |
30; 34 | — |
Summary
The number of people in the United States who have survived SCI is estimated to be approximately 273,000 persons. Around 50% of the injuries are to the cervical spine resulting in tetraplegia. An important rehabilitation goal in this population is recovery of upper limb function, which could decrease medical costs and improve their quality of life. Re-establishing active grasp and pinch strength to the hand can be accomplished by surgeries that transfer the tendon of a strong muscle to restore strength to a paralyzed muscle, but the outcomes of the surgeries are variable. The investigators have demonstrated in an ongoing study, the functional gains after surgery can be improved with a focused therapy program to retrain the transferred muscle. The propose of this study is to examine the cortical mechanisms that drive successful muscle re-education after surgery. Understanding the neural (brain) activity associated with functional performance can help to predict who will respond to therapy and will guide evidence-based rehabilitation programs to improve upper limb function in tetraplegia.
Eligibility Criteria
Inclusion Criteria
- Individuals with a clinical diagnosis of SCI cervical level 4-7, complete or incomplete injuries, who have completed conventional therapy and be at least 1-year post-surgery, are eligible for the study.
- Participants must have had Br to FPL tendon transfer, be willing to participate in a 10 week exercise program, have adequate assistance or be independent in setting up exercise equipment (weight cuffs, functional tasks), and be available for two measurement sessions.
- Women and minorities may be included in the study if they meet the inclusion criteria.
- Non-Veteran participants who meet the selection criteria will be included to expand the available number of subjects.
Exclusion Criteria
- More than one tendon transfer to the thumb to restore pinch but not if they have other tendon transfer procedures on the same upper limb.
- Other exclusion criteria include pain that would limit their ability to perform the activities, spasticity in the upper limb, or spinal cord injury level above C4 or below C7 as their pattern of weakness will be substantially different.
- Subjects who are participating in other research studies that include exercise programs for the upper limb or drug studies that affect their response to exercise will also be excluded.
Data sourced from ClinicalTrials.gov (NCT02768103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.