Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits (RePlay)
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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.
    

Intervention name(s): Physical exam and medical history; Assessments; Patient Instruction and use of Device (RePlay)
Intervention type(s): Other; Diagnostic Test; Device
Intervention description(s): This will be completed by a medical doctor on the research team; One assessment in Phase I, and three assessments in Phase II (baseline, and following each 2 week active study period); providing measurable upper extremity movement, control, and coordination feedback for patients, therapists, and physicians
improving assessment and evaluation of patients involved in future interventional studies,
producing a dynamic, responsive, inexpensive physical therapy system that can be used in the comfort of the participants' own home.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group 1 will receive:
two weeks of RePlay device therapy twice per week at REACT (weeks 1-2), followed by re-assessment,
then will rest for 2 weeks (weeks 3-4),
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:
two weeks of RePlay device therapy daily at home (they will take the devices and tablet home) (weeks 1-2), followed by re-assessment,
then will rest for 2 weeks (weeks 3-4),
then will receive two weeks of RePlay device therapy twice per week at REACT (weeks 5-6), and then will undergo re-assessment.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Vagus Nerve Stimulation