Task or Virtual Reality Intervention for Improving UE Function

• ClinicalTrials.gov Identifier: NCT03811275
• Recruitment Status: Recruiting
• First Posted: January 22, 2019
• Last Update Posted: July 28, 2020
• Sponsor: Idaho State University
• Information provided by (Responsible Party): Idaho State University

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.

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

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: Randomized
• 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: Single (Investigator)
• Masking Description: The occupational therapist providing all of the functional assessments will be blinded to sequence of interventions provided.
• Primary Purpose: Treatment
• 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: December 31, 2020
• Estimated Study Completion Date: December 31, 2020

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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)

Secondary Outcome Measures :

1. 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.
2. Semi-structured interview [ Time Frame: 12 weeks ]
   Qualitative measure of the participant's perception of change in arm function after participating in the study.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Nancy L Devine, PT, DPT, MS; 2082823758; devinanc@isu.edu

Contact: Theodore Peterson, DrOT, OTR/L; 2082824631; petetheo@isu.edu

Locations

United States, Idaho

Nancy L Devine; Recruiting

Pocatello, Idaho, United States, 83209

Contact: Nancy L Devine, PT, DPT, MS 208-282-3758 devinanc@isu.edu

Contact: Theodore Peterson, DrOT, OTR/L 2082824631 petetheo@isu.edu

Sponsors and Collaborators

Idaho State University

Investigators

• Principal Investigator: Nancy L Devine, PT, DPT, MS; Idaho State University

More Information

• Responsible Party: Idaho State University
• ClinicalTrials.gov Identifier: NCT03811275
• Other Study ID Numbers: IdahoSU
• First Posted: January 22, 2019
• Last Update Posted: July 28, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Idaho State University:

upper extremity recovery of function; action observation; virtual reality; task-based intervention

Additional relevant MeSH terms:

Cerebral Palsy; Hemiplegia; Paresis; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations