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Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits (RePlay)

NCT03621969 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-02-06

No results posted yet for this study

Summary

Injuries and disease processes that produce upper extremity deficits are devastating to patients and their families. One potential avenue to treat these neurological disorders is through the enhancement of neural plasticity, which is the ability of the brain to reorganize and recover following insult. After a minor injury, the brain undergoes beneficial neural plasticity, compensating for altered neural activity to restore normal function. However, in the cases of moderate to severe injury and disease, e.g. spinal cord injury (SCI), insufficient or improper plasticity limits recovery, leaving patients with long-term disability. Therefore, methods that can drive robust and specific plasticity have great potential to treat neurological injuries and disease.

The Texas Biomedical Device Center (TXBDC) at UT Dallas has developed a groundbreaking therapy, called Targeted Plasticity Therapy (TPT), which pairs traditional motor, sensory, and cognitive rehabilitation with precise stimulation of the vagus nerve, to guide such robust and specific plasticity to treat a wide range of neurological deficits.

Conditions

  • Spinal Cord Injuries

Interventions

OTHER

Physical exam and medical history

This will be completed by a medical doctor on the research team

DIAGNOSTIC_TEST

Assessments

One assessment in Phase I, and three assessments in Phase II (baseline, and following each 2 week active study period)

DEVICE

Patient Instruction and use of Device (RePlay)

1. providing measurable upper extremity movement, control, and coordination feedback for patients, therapists, and physicians 2. improving assessment and evaluation of patients involved in future interventional studies, 3. producing a dynamic, responsive, inexpensive physical therapy system that can be used in the comfort of the participants' own home.

Sponsors & Collaborators

  • The University of Texas at Dallas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-10
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621969 on ClinicalTrials.gov