Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03811275 |
| Other study ID # |
IdahoSU |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 8, 2018 |
| Est. completion date |
April 26, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Idaho State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
People with one arm that does not function well due to a stroke, head injury, or cerebral
palsy, and a fully functional other arm, will be randomly assigned to receive one of the two
interventions first, followed by the other intervention. The two interventions include a
task-based intervention and a virtual reality intervention that provides a reflected image of
the involved arm. The task-based intervention will consist of setting up activities of
interest to be done using the involved arm and structuring practice and meaningful feedback
to assist learning. The virtual reality intervention will consist of the person wearing the
virtual reality device and practicing virtual tasks using the intact arm while seeing the
involved arm. Intervention sessions will last approximately 30 minutes and will be held 3
times/week for 3 weeks each for a total of 9 sessions for each intervention. Testing of the
involved arm's function will be done before the interventions, after receiving 9 sessions of
each intervention, and one month after completing the second intervention received.
Description:
Potential participants will be screened for age, history of stroke, brain injury, or cerebral
palsy, and having one functional arm and one poorly functioning arm by phone. Those who meet
the basic criteria will be scheduled for an Intake Evaluation consisting of obtaining
voluntary informed consent, complete a demographic survey, visual field testing, cognitive
screening, perceptual testing, and an arm/hand function test. Participants who meet the
inclusion criteria will be scheduled for a Preliminary Evaluation.
The Preliminary Evaluation will measure the current motor control ability, perception of
level of disability, and amount of active and passive motion in the involved arm.
Participants will participate in the first form of intervention (randomly assigned) for three
30 minute sessions per week for 3 weeks (total of 9 sessions) and be re-evaluated using the
same tests conducted during the Preliminary Evaluation with the addition of the arm/hand
function test conducted during the initial screening.
Participants will participate in the second form of intervention for three 30 minute sessions
per week for 3 weeks (total of 9 sessions) and be re-evaluated using the same tests conducted
following the first intervention.
One month after completing the second form of intervention, participants will be re-evaluated
using the same tests used following the second intervention and will also receive a
semi-structured interview regarding their thoughts and experiences during the study and their
perceptions of the outcomes.
