StrokeNCT03005457
Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy
A study testing Hemiparesis Therapy with VR in people with Stroke and Hemiparesis, run by Ohio State University at 1 site in United States.
Trial summary
Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy. Pre/post study design. Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis, Upper Extremity Dysfunction
- What is being tested?
- Hemiparesis Therapy with VR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female aged > 17
- Preserved ability to comprehend English and participate in basic elements of the therapy
- Community-dwelling
- Experienced mild to moderate hemiparesis at least six months prior
- Can independently operate the gaming system (those with severe cognitive impairments can usually achieve this)
- Corrected vision of at least 20/70 as assessed by their ability to identify game objects on the monitor from 5 feet away
Who cannot join
- concurrent participation in other experimental upper extremity trials
- concurrent participation in other outpatient rehabilitation for their upper extremity
- Botox within the last 3 months (confound)
- near-normal motor function (9-hole Peg Test score above the 10th percentile of a normative sample)
- minimal nonuse (Motor Activity Log at baseline >2.5, Accelerometry > 60%)
- major medical issues that would interfere with study treatments or make intensive rehabilitation difficult to tolerate
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University, 2154 Dodd Hall
Columbus, Ohio, 43210
About this study
Official title: A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis
Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy. Pre/post study design. Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including completion of a behavioral contract at the first study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and post-treatment testing performed within 1 week prior to and 1 week post-intervention by an independent tester.
- Conditions
- Stroke, Hemiparesis, Upper Extremity Dysfunction
- Being tested
- Hemiparesis Therapy with VR
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemiparesis Therapy with VRBehavioural
An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Experimental | Not described Receives: Behavioral: Hemiparesis Therapy with VR |
| Hemiparesis other | Experimental | Not described Receives: Behavioral: Hemiparesis Therapy with VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Motor Activity Log
Self-report measure of arm use for daily activities
Measured: Week 0 and Week 3
Change in Wolf Motor Function Test
Objective measure of motor function in a laboratory setting
Measured: Week 0 and Week 3
Secondary outcomes (12)
Kinematic Data
Kinematic data recorded during game play
Measured: Week 0 and Week 3
Brief Kinesthesia test
Clinical Assessment of sensation
Measured: Week 0 and Week 3
Patient Health Questionnaire
Measures Depression
Measured: Week 0 and Week 3
Strok Specific Quality of Life Scale
Quality of life measurement
Measured: Week 0 and Week 3
Weschler Adult Intelligence Scale Symbol Seach
Cognitive processing speed assessment
Measured: Week 0 and Week 3
Montreal Cognitive Assessment
Baseline cognitive screen
Measured: Week 0 and Week 3
Survey
Survey on satisfaction with the intervention
Measured: Week 0 and Week 3
Mitt Compliance
Hours of use
Measured: Week 0 and Week 3
Total game-play time
Measured: Week 0 and Week 3
Gestures
Number of gestures of each type registered in game
Measured: Week 0 and Week 3
Bilateral activity monitors
Objective measure of arm use
Measured: Week 0 and Week 3
Action Research Arm Test (ARAT)
Asses Changes in Limb Function
Measured: Week 0 and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJul 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Principal investigator, Lynne Gauthier , PhD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005457
- Sponsor's protocol ID
- 60047824
- Status last verified
- Dec 2016
- First submitted
- 21 Dec 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will be shared upon publication acceptance.
Publications
Kelly KM, Borstad AL, Kline D, Gauthier LV. Improved quality of life following constraint-induced movement therapy is associated with gains in arm use, but not motor improvement. Top Stroke Rehabil. 2018 Oct;25(7):467-474. doi: 10.1080/10749357.2018.1481605. Epub 2018 Sep 22.
PubMed 30246613
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis
- ClinicalTrials.gov ID
- NCT03005457
- Acronym / sponsor ID
- 60047824
- Conditions
- Stroke, Hemiparesis, Upper Extremity Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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.
Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy. Pre/post study design. Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including completion of a behavioral contract at the first study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and post-treatment testing performed within 1 week prior to and 1 week post-intervention by an independent tester.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | Experimental | Behavioral: Hemiparesis Therapy with VR |
| Hemiparesis other | Experimental | Behavioral: Hemiparesis Therapy with VR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female aged > 17
- Preserved ability to comprehend English and participate in basic elements of the therapy
- Community-dwelling
Key exclusion criteria (6 listed)
- concurrent participation in other experimental upper extremity trials
- concurrent participation in other outpatient rehabilitation for their upper extremity
- Botox within the last 3 months (confound)
- near-normal motor function (9-hole Peg Test score above the 10th percentile of a normative sample)
- minimal nonuse (Motor Activity Log at baseline >2.5, Accelerometry > 60%)
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 |
|---|---|---|
| Hemiparesis Therapy with VRAn in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids | Behavioural | Hemiparesis other, Stroke |
Primary outcome
Change in Motor Activity Log
Time frame: Week 0 and Week 3
Self-report measure of arm use for daily activities
Change in Wolf Motor Function Test
Time frame: Week 0 and Week 3
Objective measure of motor function in a laboratory setting
12 secondary outcomes
Kinematic Data
Time frame: Week 0 and Week 3
Brief Kinesthesia test
Time frame: Week 0 and Week 3
Patient Health Questionnaire
Time frame: Week 0 and Week 3
Strok Specific Quality of Life Scale
Time frame: Week 0 and Week 3
Weschler Adult Intelligence Scale Symbol Seach
Time frame: Week 0 and Week 3
Montreal Cognitive Assessment
Time frame: Week 0 and Week 3
Survey
Time frame: Week 0 and Week 3
Mitt Compliance
Time frame: Week 0 and Week 3
Total game-play time
Time frame: Week 0 and Week 3
Gestures
Time frame: Week 0 and Week 3
Bilateral activity monitors
Time frame: Week 0 and Week 3
Action Research Arm Test (ARAT)
Time frame: Week 0 and Week 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Derived from this study: PubMed 30246613Kelly KM, Borstad AL, Kline D, Gauthier LV. Improved quality of life following constraint-induced movement therapy is associated with gains in arm use, but not motor improvement. Top Stroke Rehabil. 2018 Oct;25(7):467-474. doi: 10.1080/10749357.2018.1481605. Epub 2018 Sep 22.
- Individual participant dataSharing planned: Yes. Will be shared upon publication acceptance.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemiparesis Therapy with VR in people with Stroke and Hemiparesis, run by Ohio 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 29 Dec 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Motor Activity Log (time frame: Week 0 and Week 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03005457, which also lists 1 linked publication.
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 29 Dec 2016.