Neural Adaptation After Tendon Transfer and Training in Tetraplegia

NCT02768103 | Completed Results

• 1 other identifier: N1772-P
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

upper extremity; spinal cord injury; surgical reconstruction; MRI, functional; rehabilitation

Outcome Measures

Primary Outcomes (2)

• Pinch Force

  Pinch force recorded in newtons from force sensor mounted to a custom grip

  after 10 weeks home exercise program with task-based training

• Functional MRI BOLD Signal From Motor Cortex

  A block design with 10 seconds of rest alternating with 10 seconds of functional movement for 6 minutes will be followed. Participants have visual cues to instruct them in the timing and sequence of the tasks to be performed. Scan time to include a session of elbow flexion and a session for pinch is about 20 minutes. The main outcome measures for the fMRI data will be brain activation defined by intensity and cluster size in response to performing elbow flexion and pinch. Second level analyses will be mixed models effects derived using FSL FLAME for within subjects (pre to post intervention) as well as cross-sectional (non impaired vs. SCI-ns; SCI-ns vs. SCI+TT) individual models (with outlier deweighting and standard settings).

  after 10 week home exercise program with task-based training

Secondary Outcomes (1)

• Fine-wire Electromyography of Transferred Brachioradialis Muscle (to Paralyzed Thumb Flexor)

  after 10 week home exercise program with task-based training

Study Arms (1)

SCI transfer + training

EXPERIMENTAL

Individuals with tetraplegia and brachioradialis to flexor pollicis longus transfer will participate in 10 week home training program to improve surgical outcome (pinch strength)

Behavioral: task-based training

Interventions

task-based training BEHAVIORAL

The 10-week training program is designed to incorporate requirements of motor learning and includes activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback and knowledge of progress to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.

SCI transfer + training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Non-Veteran participants who meet the selection criteria will be included to expand the available number of subjects.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Related Publications (1)

• Johanson ME, Dairaghi CA, Hentz VR. Evaluation of a Task-Based Intervention After Tendon Transfer to Restore Lateral Pinch. Arch Phys Med Rehabil. 2016 Jun;97(6 Suppl):S144-53. doi: 10.1016/j.apmr.2015.12.032.

  PMID: 27233589 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

No valid data to report for functional MRI outcome.

Results Point of Contact

• Title: Dr Johanson
• Organization: VA Palo Alto Health Care System

lisa.johanson29@gmail.com

408-250-1982

Study Officials

• Mary E Johanson, DPT

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: All participants complete 10 week task based training in home setting.

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: November 15, 2022
• Results First Posted: April 15, 2020

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)