Task or Virtual Reality Intervention for Improving UE Function

Functional Outcomes Following Task-based and VR Action Observation Interventions for Adults With Chronic Hemiparesis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Upper Extremity Paresis; Hemiplegic Cerebral Palsy; Hemiplegia and/or Hemiparesis Following Stroke
• Intervention / Treatment: Behavioral: Virtual Reality (A) then Task (B); Behavioral: Task (B) then Virtual Reality (A)

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Pocatello, Idaho, United States, 83209
      • Nancy L Devine

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl-Meyer Assessment (UE portion)	Performance-based measure of arm impairment post stroke; a positive change in score indicates improvement	1st week, 4 weeks, 8 weeks, 12 weeks
Change in Box & Block Test	Measures unilateral gross manual dexterity; a positive change in score indicates improvement	1st week, 4 weeks, 8 weeks, 12 weeks
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)	1st week, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1st week, 4 weeks, 8 weeks, 12 weeks
Semi-structured interview	Qualitative measure of the participant's perception of change in arm function after participating in the study.	12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2018
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality; action observation; upper extremity recovery of function; task-based intervention
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Paralysis; Cerebral Palsy; Hemiplegia; Paresis
• Other Study ID Numbers: IdahoSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No