Upper Extremity ParesisNCT03811275
Task or Virtual Reality Intervention for Improving UE Function
A study testing Virtual Reality (A) then Task (B) and Task (B) then Virtual Reality (A) in people with Upper Extremity Paresis and Hemiplegia and/or Hemiparesis Following Stroke, run by Idaho State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Upper Extremity Paresis, Hemiplegia and/or Hemiparesis Following Stroke, Hemiplegic Cerebral Palsy
- What is being tested?
- Virtual Reality (A) then Task (B) and Task (B) then Virtual Reality (A)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2018to 26 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Upper Extremity Paresis, Hemiplegia and/or Hemiparesis Following Stroke, Hemiplegic Cerebral Palsy
- Being tested
- Virtual Reality (A) then Task (B), Task (B) then Virtual Reality (A)
- Keywords
- upper extremity recovery of function, action observation, virtual reality, task-based intervention
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (A) then Task (B)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Task (B) then Virtual Reality (A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment (UE portion)
Performance-based measure of arm impairment post stroke; a positive change in score indicates improvement
Measured: 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
Measured: 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)
Measured: 1st week, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start8 Sep 2018
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Why it stopped: The study was stopped during the COVID-19 Pandemic in March 2020 to prevent transmission. It did not reopen due to aging of the virtual reality technology.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity ParesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idaho State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy L Devine, PT, DPT, MS, Principal investigator, Idaho State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811275
- Sponsor's protocol ID
- IdahoSU
- Status last verified
- May 2023
- First submitted
- 16 Jan 2019
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes Following Task-based and VR Action Observation Interventions for Adults With Chronic Hemiparesis
- ClinicalTrials.gov ID
- NCT03811275
- Acronym / sponsor ID
- IdahoSU
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped during the COVID-19 Pandemic in March 2020 to prevent transmission. It did not reopen due to aging of the virtual reality technology.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Idaho State UniversityUniversity, hospital or other
- Study start
- 8 Sep 2018 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 22 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Sequence #1 | Experimental | Behavioral: Virtual Reality (A) then Task (B)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. |
| Sequence #2 | Experimental | Behavioral: Task (B) then Virtual Reality (A)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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Sequence #1 |
| 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. | Behavioural | Sequence #2 |
Primary outcome
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
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
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)
2 secondary outcomes
Change in Active and Passive Range of Motion
Time frame: 1st week, 4 weeks, 8 weeks, 12 weeks
Semi-structured interview
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: The study was stopped during the COVID-19 Pandemic in March 2020 to prevent transmission. It did not reopen due to aging of the virtual reality technology.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy L Devine, PT, DPT, MS principal investigator
Idaho State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality (A) then Task (B) and Task (B) then Virtual Reality (A) in people with Upper Extremity Paresis and Hemiplegia and/or Hemiparesis Following Stroke, run by Idaho State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was stopped during the COVID-19 Pandemic in March 2020 to prevent transmission. It did not reopen due to aging of the virtual reality technology.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment (UE portion) (time frame: 1st week, 4 weeks, 8 weeks, 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.