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Trial record 2 of 28 for:    REPLAY

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03621969
Recruitment Status : Unknown
Verified March 2020 by Victoria Warren, The University of Texas at Dallas.
Recruitment status was:  Recruiting
First Posted : August 9, 2018
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Victoria Warren, The University of Texas at Dallas

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE January 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Evaluate the rehabilitation device design as reported by subjects using a 10-point Likert scale [ Time Frame: Through Study Completion, approximately 8-9 weeks ]
    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.
  • Evaluate the functionality of rehabilitation device as reported by subjects using a 10-point Likert scale [ Time Frame: Through Study Completion approximately 8-9 weeks ]
    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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits (RePlay)
Official Title  ICMJE Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Spinal Cord Injuries
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Group 1

    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.
    Interventions:
    • Other: Physical exam and medical history
    • Diagnostic Test: Assessments
    • Device: Patient Instruction and use of Device (RePlay)
  • Experimental: Group 2

    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.
    Interventions:
    • Other: Physical exam and medical history
    • Diagnostic Test: Assessments
    • Device: Patient Instruction and use of Device (RePlay)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 8, 2018)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03621969
Other Study ID Numbers  ICMJE 16-74
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Victoria Warren, The University of Texas at Dallas
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The University of Texas at Dallas
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The University of Texas at Dallas
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP