Task or Virtual Reality Intervention for Improving UE Function

Hemiplegic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03811275
• Other study ID #: IdahoSU
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 8, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Idaho State University
• Contact: n/a
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegia
• Hemiplegia and/or Hemiparesis Following Stroke
• Hemiplegic Cerebral Palsy
• Paresis
• Upper Extremity Paresis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Nancy L Devine	Pocatello	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
Idaho State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Semi-structured interview	Qualitative measure of the participant's perception of change in arm function after participating in the study.	12 weeks