Task or Virtual Reality Intervention for Improving UE Function
Primary Purpose
Upper Extremity Paresis, Hemiplegia and/or Hemiparesis Following Stroke, Hemiplegic Cerebral Palsy
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality (A) then Task (B)
Task (B) then Virtual Reality (A)
Sponsored by
About this trial
This is an interventional treatment trial for Upper Extremity Paresis focused on measuring upper extremity recovery of function, action observation, virtual reality, task-based intervention
Eligibility Criteria
Inclusion Criteria:
- 18 - 89 years old
- One arm not fully functional due to a stroke, brain injury, or cerebral palsy
- More than 1 year since neurologic even that impaired arm function
Exclusion Criteria:
- Cognitive impairment
- visual field loss (homonymous hemianopsia)
- perceptual deficits (MVPT4 lower than 2 standard deviations from the norm)
- Seizure disorder
- Currently receiving rehabilitation services (PT or OT) for the involved arm.
Sites / Locations
- Nancy L Devine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence #1
Sequence #2
Arm Description
Participants will receive nine 30 minute sessions (over 3 weeks) of intervention A followed by nine 30 minute sessions (over 3 weeks) of intervention B.
Participants will receive nine 30 minute sessions (over 3 weeks) of intervention B followed by nine 30 minute sessions (over 3 weeks) of intervention B.
Outcomes
Primary Outcome Measures
Change in Fugl-Meyer Assessment (UE portion)
Performance-based measure of arm impairment post stroke; a positive change in score indicates improvement
Change in Box & Block Test
Measures unilateral gross manual dexterity; a positive change in score indicates improvement
Change in Stroke Impact Scale 3.0
Self-report health status measure; The Total Score and Subscale Scores range from 0 - 100 with higher scores indicating less perceived impact of the stroke on function and participation (positive change in scores indicate improvement)
Secondary Outcome Measures
Change in Active and Passive Range of Motion
Goniometric measures of active and passive range of motion of the elbow extension, wrist extension, and thumb radial abduction.
Semi-structured interview
Qualitative measure of the participant's perception of change in arm function after participating in the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03811275
Brief Title
Task or Virtual Reality Intervention for Improving UE Function
Official Title
Functional Outcomes Following Task-based and VR Action Observation Interventions for Adults With Chronic Hemiparesis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 8, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Idaho State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Extremity Paresis, Hemiplegia and/or Hemiparesis Following Stroke, Hemiplegic Cerebral Palsy
Keywords
upper extremity recovery of function, action observation, virtual reality, task-based intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All participants will receive both interventions (A and B) and will be randomly assigned to the sequence in which they receive them (AB or BA).
Masking
Investigator
Masking Description
The occupational therapist providing all of the functional assessments will be blinded to sequence of interventions provided.
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sequence #1
Arm Type
Experimental
Arm Description
Participants will receive nine 30 minute sessions (over 3 weeks) of intervention A followed by nine 30 minute sessions (over 3 weeks) of intervention B.
Arm Title
Sequence #2
Arm Type
Experimental
Arm Description
Participants will receive nine 30 minute sessions (over 3 weeks) of intervention B followed by nine 30 minute sessions (over 3 weeks) of intervention B.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality (A) then Task (B)
Intervention Description
Participants will use their intact arm to perform virtual reality tasks while perceiving a reflected virtual image of their paretic arm.
Intervention Type
Behavioral
Intervention Name(s)
Task (B) then Virtual Reality (A)
Intervention Description
Participants will use their paretic arm to perform real tasks in a structured environment, with a practice and feedback schedule organized by a physical or occupational therapist, or graduate student.
Primary Outcome Measure Information:
Title
Change in Fugl-Meyer Assessment (UE portion)
Description
Performance-based measure of arm impairment post stroke; a positive change in score indicates improvement
Time Frame
1st week, 4 weeks, 8 weeks, 12 weeks
Title
Change in Box & Block Test
Description
Measures unilateral gross manual dexterity; a positive change in score indicates improvement
Time Frame
1st week, 4 weeks, 8 weeks, 12 weeks
Title
Change in Stroke Impact Scale 3.0
Description
Self-report health status measure; The Total Score and Subscale Scores range from 0 - 100 with higher scores indicating less perceived impact of the stroke on function and participation (positive change in scores indicate improvement)
Time Frame
1st week, 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
Change in Active and Passive Range of Motion
Description
Goniometric measures of active and passive range of motion of the elbow extension, wrist extension, and thumb radial abduction.
Time Frame
1st week, 4 weeks, 8 weeks, 12 weeks
Title
Semi-structured interview
Description
Qualitative measure of the participant's perception of change in arm function after participating in the study.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 - 89 years old
One arm not fully functional due to a stroke, brain injury, or cerebral palsy
More than 1 year since neurologic even that impaired arm function
Exclusion Criteria:
Cognitive impairment
visual field loss (homonymous hemianopsia)
perceptual deficits (MVPT4 lower than 2 standard deviations from the norm)
Seizure disorder
Currently receiving rehabilitation services (PT or OT) for the involved arm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy L Devine, PT, DPT, MS
Organizational Affiliation
Idaho State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nancy L Devine
City
Pocatello
State/Province
Idaho
ZIP/Postal Code
83209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Task or Virtual Reality Intervention for Improving UE Function
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