Task or Virtual Reality Intervention for Improving UE Function

April 26, 2024 updated by: Idaho State University

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1st week, 4 weeks, 8 weeks, 12 weeks
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
1st week, 4 weeks, 8 weeks, 12 weeks
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)
1st week, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1st week, 4 weeks, 8 weeks, 12 weeks
Semi-structured interview
Time Frame: 12 weeks
Qualitative measure of the participant's perception of change in arm function after participating in the study.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Idaho State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nancy L Devine, PT, DPT, MS, Idaho State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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