Task or Virtual Reality Intervention for Improving UE Function
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|ClinicalTrials.gov Identifier: NCT03811275|
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : January 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Upper Extremity Paresis Hemiplegia and/or Hemiparesis Following Stroke Hemiplegic Cerebral Palsy||Behavioral: Virtual Reality (A) then Task (B) Behavioral: Task (B) then Virtual Reality (A)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Intervention 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 Description:||The occupational therapist providing all of the functional assessments will be blinded to sequence of interventions provided.|
|Official Title:||Functional Outcomes Following Task-based and VR Action Observation Interventions for Adults With Chronic Hemiparesis|
|Actual Study Start Date :||September 8, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Experimental: Sequence #1
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.
Behavioral: Virtual Reality (A) then Task (B)
Participants will use their intact arm to perform virtual reality tasks while perceiving a reflected virtual image of their paretic arm.
Experimental: Sequence #2
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.
Behavioral: Task (B) then Virtual Reality (A)
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.
- Change in Fugl-Meyer Assessment (UE portion) [ Time Frame: 1st week, 4 weeks, 8 weeks, 12 weeks ]Performance-based measure of arm impairment post stroke; a positive change in score indicates improvement
- Change in Box & Block Test [ Time Frame: 1st week, 4 weeks, 8 weeks, 12 weeks ]Measures unilateral gross manual dexterity; a positive change in score indicates improvement
- Change in Stroke Impact Scale 3.0 [ Time Frame: 1st week, 4 weeks, 8 weeks, 12 weeks ]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)
- Change in Active and Passive Range of Motion [ Time Frame: 1st week, 4 weeks, 8 weeks, 12 weeks ]Goniometric measures of active and passive range of motion of the elbow extension, wrist extension, and thumb radial abduction.
- Semi-structured interview [ Time Frame: 12 weeks ]Qualitative measure of the participant's perception of change in arm function after participating in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811275
|Contact: Nancy L Devine, PT, DPT, MSemail@example.com|
|Contact: Theodore Peterson, DrOT, OTR/Lfirstname.lastname@example.org|
|United States, Idaho|
|Nancy L Devine||Recruiting|
|Pocatello, Idaho, United States, 83209|
|Contact: Nancy L Devine, PT, DPT, MS 208-282-3758 email@example.com|
|Contact: Theodore Peterson, DrOT, OTR/L 2082824631 firstname.lastname@example.org|
|Principal Investigator:||Nancy L Devine, PT, DPT, MS||Idaho State University|