Spinal Cord InjuriesRePlayNCT03621969
Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits (RePlay)
A study testing Physical exam and medical history, Assessments and Patient Instruction and use of Device (RePlay) in people with Spinal Cord Injuries, run by The University of Texas at Dallas at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Physical exam and medical history, Assessments and Patient Instruction and use of Device (RePlay)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Partial upper limb impairment in one or both arms as a result of a neurological injury or disease
- Age 18-65
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
REACT
Addison, Texas, 75001
UT Dallas
Richardson, Texas, 75080
About this study
Official title: Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits
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.
Read the 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:
- 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 tablets home for two weeks (weeks 5-6) for daily RePlay 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 tablets 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.
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Physical exam and medical history, Assessments, Patient Instruction and use of Device (RePlay)
- Keywords
- Vagus Nerve Stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exam and medical historyOther
This will be completed by a medical doctor on the research team
AssessmentsDiagnostic test
One assessment in Phase I, and three assessments in Phase II (baseline, and following each 2 week active study period)
Patient Instruction and use of Device (RePlay)Device
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical exam and medical history; Diagnostic Test: Assessments; Device: Patient Instruction and use of Device (RePlay) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Through Study Completion approximately 8-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start10 Oct 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Rennaker, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621969
- Sponsor's protocol ID
- 16-74
- Acronym
- RePlay
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2017
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Development for Physical Rehabilitation of Patients With Upper Extremity Motor Deficits
- ClinicalTrials.gov ID
- NCT03621969
- Acronym / sponsor ID
- RePlay / 16-74
- Conditions
- Spinal Cord Injuries
- Keywords
- Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 tablets home for two weeks (weeks 5-6) for daily RePlay 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 tablets 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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Physical exam and medical history, Diagnostic Test: Assessments, Device: Patient Instruction and use of Device (RePlay)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. |
| Group 2 | Experimental | Other: Physical exam and medical history, Diagnostic Test: Assessments, Device: Patient Instruction and use of Device (RePlay)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Partial upper limb impairment in one or both arms as a result of a neurological injury or disease
- Age 18-65
Key exclusion criteria (6 listed)
- Emotional disability that would interfere with participation as determined by Dr.
- Wigginton
- Inability to understand instructions in English
- No upper limb movement
- Incarcerated individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exam and medical historyThis will be completed by a medical doctor on the research team | Other | Group 1, Group 2 |
| AssessmentsOne assessment in Phase I, and three assessments in Phase II (baseline, and following each 2 week active study period) | Diagnostic test | Group 1, Group 2 |
| 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. | Device | Group 1, Group 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exam and medical history, Assessments and Patient Instruction and use of Device (RePlay) in people with Spinal Cord Injuries, run by The University of Texas at Dallas at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the rehabilitation device design as reported by subjects using a 10-point Likert scale (time frame: Through Study Completion, approximately 8-9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.