Clinical trial NCT03621969: Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits (RePlay)
Official title: Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Vagus Nerve Stimulation
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed description: The groundbreaking therapy developed at Texas Biomedical Device Center (TXBDC) , called Targeted Plasticity Therapy (TPT) 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. The success of this concomitant therapy will be furthered, in part, through the development and use of mechanical devices aimed at measuring the effects of rehabilitation in patients with an upper extremity neurological deficit, e.g. from SCI. These devices are small hand controllers used to play simple video games that can also measure force and movement. Additionally, this study will be used to inform the future development of the rehabilitation game software as well as an optional game chair (in patients that use wheelchairs, the games can also be played from the patient's own chair).

To optimize the evaluation of these RePlay devices and software, and to decrease the time requirement for patients, research will be divided into two phases. Patients can participate in either one or both phases. Participation in phase II is not contingent on participation in phase I.

Phase I will involve 80 participants using the RePlay devices and games on a single visit. These 80 participants will be a collection of participants with no neurological disorders, participants recovering from stroke, those with Multiple Sclerosis, Parkinson's Disease and Spinal Cord Injuries. This will allow us to determine the ability of these patient populations to enjoyably use these devices and games compared with their degree of impairment. Participants' degree of impairment will be quantified by standard rehabilitation measurements for each disease process, including the ASIA Spinal Cord Impairment Scale, GRASSP, Jebsen Taylor Hand Function, dynomometry strength readings

In Phase II, 20 participants will be randomized equally to one of two groups. Each group will receive the same amount of therapy, only in a different sequence.

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 tablets home for two weeks (weeks 5-6) for daily RePlay 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 tablets 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.

This will allow investigators to test the Replay rehabilitation software and hardware over 2 two week periods in order to evaluate the pattern of game play improvement in this population over time in different settings.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluate the rehabilitation device design as reported by subjects using a 10-point Likert scale
timeFrame: Through Study Completion, approximately 8-9 weeks
measure: Evaluate the functionality of rehabilitation device as reported by subjects using a 10-point Likert scale
timeFrame: Through Study Completion approximately 8-9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Addison
country: United States
facility: REACT
state: Texas
city: Richardson
country: United States
facility: UT Dallas
state: Texas
Study officials:
References: