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

NCT03621969 | Completed

• 1 other identifier: 16-74
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

• Evaluate the rehabilitation device design as reported by subjects using a 10-point Likert scale

  Assess feasibility, ease of use and enjoyment for device in injured population. This will be measured by subject report. Subjects will verbally provide feedback as they use the software and hardware. Feedback will be recorded and changes will be made based on feedback received from participants. Subjects self-report their experienced enjoyment of RePlay using a 10-point Likert scale (10 = extreme enjoyment, 1 = no enjoyment). Higher scores represent a greater degree of experienced enjoyment.

  Through Study Completion, approximately 8-9 weeks

• Evaluate the functionality of rehabilitation device as reported by subjects using a 10-point Likert scale

  Assess general fit, and functionality of these devices to further the device development. both in the home and in the rehabilitation setting. This will be measured by subject report. This will be measured by subject report. Subjects will verbally provide feedback as they use the software and hardware. Feedback will be recorded and changes will be made based on feedback received from participants. Subjects self-report their experienced fit and function of RePlay using a 10-point Likert scale (10 = extremely easy to fit, 1 = didn't fit at all). Higher scores represent a greater degree of experienced fit and function

  Through Study Completion approximately 8-9 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 will receive: 1. Medical History and Brief Physical Exam 2. Diagnostic Assessments 3. Patient Instruction and use of RePlay Device 4. two weeks of RePlay device therapy twice per week at REACT (weeks 1-2), followed by re-assessment, 5. then will rest for 2 weeks (weeks 3-4), 6. then will take the RePlay devices and tablets home for two weeks (weeks 5-6) for daily RePlay device therapy, followed by re-assessment.

Other: Physical exam and medical history; Diagnostic Test: Assessments; Device: Patient Instruction and use of Device (RePlay)

Group 2

EXPERIMENTAL

Group 2 will receive: 1. Medical History and Brief Physical Exam 2. Diagnostic Assessments 3. Patient Instruction and use of RePlay Device 4. two weeks of RePlay device therapy daily at home (they will take the RePlay devices and tablets home) (weeks 1-2), followed by re-assessment, 5. then will rest for 2 weeks (weeks 3-4), 6. then will receive two weeks of RePlay device therapy twice per week at REACT (weeks 5-6), and then will undergo re-assessment.

Other: Physical exam and medical history; Diagnostic Test: Assessments; Device: Patient Instruction and use of Device (RePlay)

Interventions

Physical exam and medical history OTHER

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

Group 1; Group 2

Assessments DIAGNOSTIC_TEST

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

Group 1; Group 2

Patient Instruction and use of Device (RePlay) DEVICE

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.

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Partial upper limb impairment in one or both arms as a result of a neurological injury or disease
• Age 18-65

You may not qualify if:

• Emotional disability that would interfere with participation as determined by Dr.
• Wigginton
• Inability to understand instructions in English
• No upper limb movement
• Incarcerated individuals
• For Phase II, anticipated inability to complete study visits

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (2)

REACT

Addison, Texas, 75001, United States

Location

UT Dallas

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Restraint, Physical; Health Records, Personal; Physical Examination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Medical Records; Records; Data Collection; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Group 1 will receive: 1. two weeks of RePlay device therapy twice per week at REACT (weeks 1-2), followed by re-assessment, 2. then will rest for 2 weeks (weeks 3-4), 3. then will take the RePlay devices and tablet computer home for two weeks (weeks 5-6) for daily device therapy, followed by re-assessment. Group 2 will receive: 1. two weeks of RePlay device therapy daily at home (they will take the devices and tablet home) (weeks 1-2), followed by re-assessment, 2. then will rest for 2 weeks (weeks 3-4), 3. then will receive two weeks of RePlay device therapy twice per week at REACT (weeks 5-6), and then will undergo re-assessment.

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: August 9, 2018
• Study Start: October 10, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)