Task or Virtual Reality Intervention for Improving UE Function

NCT03811275 | Terminated

• 1 other identifier: IdahoSU
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in Active and Passive Range of Motion

  1st week, 4 weeks, 8 weeks, 12 weeks

• Semi-structured interview

  12 weeks

Study Arms (2)

Sequence #1

EXPERIMENTAL

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)

Sequence #2

EXPERIMENTAL

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)

Interventions

Virtual Reality (A) then Task (B) BEHAVIORAL

Participants will use their intact arm to perform virtual reality tasks while perceiving a reflected virtual image of their paretic arm.

Sequence #1

Task (B) then Virtual Reality (A) BEHAVIORAL

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.

Sequence #2

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Idaho State University: lead

Study Sites (1)

Nancy L Devine

Pocatello, Idaho, 83209, United States

Location

MeSH Terms

Conditions

Paresis

Interventions

potassium channel subfamily K member 3

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy L Devine, PT, DPT, MS

  Idaho State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The occupational therapist providing all of the functional assessments will be blinded to sequence of interventions provided.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 22, 2019
• Study Start: September 8, 2018
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: April 30, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)