StrokeNCT02631850
Effectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity Rehabilitation
A study testing Traditional CI Therapy, Gaming CI Therapy and Gaming CI Therapy with Additional Contact via Video Conference in people with Stroke and Hemiparesis, run by Ohio State University at 5 sites in United States.
Trial summary
The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group equating the dose of in-person therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Traditional CI Therapy, Gaming CI Therapy and Gaming CI Therapy with Additional Contact via Video Conference
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2015to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males, females, or any gender identity 18 years of age or older
- Experienced a stroke resulting in mild-to-moderate hemiparesis at least six months prior to enrollment (suggested range of motion (ROM) criteria includes: 45° shoulder abduction and flexion, 20° elbow extension, 20° wrist extension, and 10° extension of thumb and finger)
- Have preserved ability to comprehend and participate in basic elements of the therapy
Who cannot join
- Concurrent participation in other experimental trials for motor dysfunction treatment
- Receiving Botox therapy currently or in the past 3 months
- Have medical conditions that would place volunteers at higher risk of adverse events (e.g., renal disease, frailty, pregnancy, dementia, severe pain, end-stage/degenerative diseases)
- Have received intensive upper-extremity rehabilitation in the chronic phase post-stroke
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of Missouri
Columbia, Missouri
The Ohio State University, 2154 Dodd Hall
Columbus, Ohio, 43210
OhioHealth Rehabilitation
Columbus, Ohio, 43220
Providence Medford Medical Center
Medford, Oregon, 97504
About this study
Official title: Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): A Multi-center Comparative Effectiveness Trial of In-home Gamified Constraint-induced Movement Therapy for Rehabilitation of Chronic Upper Extremity Hemiparesis.
The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group equating the dose of in-person therapy. Individuals with chronic stroke will be randomized to one of four different interventions: (1) traditional clinic-based CI therapy (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy (5 therapist/client contact hours in the clinic and 15 hours of independent game play at home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist contact via telerehabilitation (5 therapist/client contact hours in the clinic, 2.6 therapist contact hours via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard occupational therapy (OT) / physical therapy (PT). After 6-month follow-up, individuals assigned to standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone application of the rehabilitation game without additional therapist contact).
Read the detailed description
Detailed study description published in BMC Neurology (2017).
- Conditions
- Stroke, Hemiparesis
- Being tested
- Traditional CI Therapy, Gaming CI Therapy, Gaming CI Therapy with Additional Contact via Video Conference, Traditional Occupational Therapy/Physical Therapy
- Keywords
- Constraint-induced movement therapy, gaming, virtual reality, upper extremity, CI therapy, rehabilitation, stroke, hemiparesis, therapy, self-management, in-home, remote, telerehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional CI TherapyBehavioural
Intensive in-person therapy for upper extremity hemiparesis.
Gaming CI TherapyBehavioural
Intensive remote (via video game) therapy for upper extremity hemiparesis.
Gaming CI Therapy with Additional Contact via Video ConferenceBehavioural
Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
Traditional Occupational Therapy/Physical TherapyBehavioural
Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
| Study group | Role | What they receive |
|---|---|---|
| Traditional CI Therapy | Active comparator | Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals. Receives: Behavioral: Traditional CI Therapy |
| Gaming CI Therapy | Active comparator | 15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life. Receives: Behavioral: Gaming CI Therapy |
| Gaming CI Therapy with Additional Contact via Video Conference | Active comparator | This group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period. Receives: Behavioral: Gaming CI Therapy with Additional Contact via Video Conference |
| Traditional Occupational Therapy/Physical Therapy | Active comparator | Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on activities of daily living (ADLs) with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system. Receives: Behavioral: Traditional Occupational Therapy/Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Assesses the time to complete 15 standardized tasks (e.g., folding a towel, stacking checkers, placing hand on top of a box). Items that cannot be accomplished score 120 seconds. Times are natural log transformed to reflect proportional improvement (approximate % change) and correct for skew. On the log transformed scale, -.22 reflects normal ability, 4.79 = can't accomplish task. For improvement in mean log transformed performance time, -4.79 = best possible improvement, 0 = no improvement, positive scores = worsening. A proportional improvement of 16% (mean log transformed performance time change = -.17) is considered clinically meaningful.
Measured: 0 to 1 months
Motor Activity Log Quality of Movement Scale
Assessment evaluates the amount and quality of everyday arm use. The scale consists of 28 activities of daily living (e.g., washing hands, drinking from a cup). Participants self-report on an 11-point scale (0-5 with half-point increments, 0=not attempted to 5=attempted with normal movement). The total score on the measure reflects the mean of the individual item scores. A change of 1.0 on the scale is considered clinically meaningful.
Measured: 0 to 1 months
Secondary outcomes (5)
Change in Neuro-Quality of Life (Neuro-QOL)
Computerized adaptive assessment on several domains of quality of life: sleep, mobility, positive affect and well-being, fatigue, satisfaction with social roles, cognitive function, anxiety, and communication. Neuro-QOL uses a T score which has a mean of 50 and SD of 10, based on the norming sample used. All Neuro-QOL banks and scales are scored such that a higher score reflects more of what is being measured. Scores are reported as mean T-scores across the assessed domains. Positive changes indicate an improvement.
Measured: 0 to 1 months
Bilateral Activity Monitors
Devices to monitor upper extremity movement are worn throughout treatment. The devices count movements made with each arm, defined as an acceleration of 2g for at least 500 ms. The ratio of more affected to less affected arm use is then calculated for each treatment day. The best linear fit trajectory for each participant is calculated after removal of outliers. The treatment change reported here reflects the difference between the best-fit-line at post-treatment and the best-fit-line at pre-treatment. Positive change indicates improvement.
Measured: 0 to 1 month
Change in Brief Kinesthesia Test (BKT)
This measures was intended to measure proprioception in the upper extremity; however, performance on the measure is also known to be adversely affected by motor impairment. The experimenter guides individuals along movement trajectories between 2 and 9 inches with their vision obscured. They are then asked to reproduce the movement trajectories. The summed difference between the desired and produced trajectory endpoints in cm is reported. A negative change indicates an improvement.
Measured: 0 to 1 months
Semmes-Weinstein Monofilament Test
Sensory evaluator of touch sensation. Units are the log transformed grams of pressure detected by the index finger of the paretic hand. Scores range from -1.8 to 5.7. Smaller scores indicate better sensation. Negative change indicates improvement.
Measured: 0 to 1 months
9 Hole Peg Test
Assessment to measure upper extremity distal motor function. The assessment measures the time to place 9 pegs into grooves on a board. Due to the inability of a majority of the participants to place all 9 pegs during the 120 seconds allotted for the test, performance was transformed into a rate metric to reduce floor effects. The outcome is expressed as change in the number of pegs per minute.
Measured: 0 to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- OhioHealth, Providence Medical Research Center, University of Alabama at Birmingham, University of Massachusetts, Lowell, University of Missouri-Columbia
- Responsible party
- Principal investigator, Deborah S Larsen, Ohio State University
- Investigators
- Deborah Larsen, PhD, Principal investigator, The Ohio State U.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631850
- Sponsor's protocol ID
- 2012H0151
- Status last verified
- Sep 2021
- First submitted
- 14 Dec 2015
- Last updated
- 5 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be made public upon publication.
Publications
Gauthier LV, Kane C, Borstad A, Strahl N, Uswatte G, Taub E, Morris D, Hall A, Arakelian M, Mark V. Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis. BMC Neurol. 2017 Jun 8;17(1):109. doi: 10.1186/s12883-017-0888-0.
PubMed 28595611Gauthier LV, Ravi R, DeLuca D, Zhou W. Dose Response to Upper Extremity Stroke Rehabilitation Varies by Individual: Early Indicators of Treatment Response. Stroke. 2024 Mar;55(3):696-704. doi: 10.1161/STROKEAHA.123.045039. Epub 2024 Feb 26.
PubMed 38406850Borstad A, Nichols-Larsen D, Uswatte G, Strahl N, Simeo M, Proffitt R, Gauthier L. Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Aug;36(8):525-534. doi: 10.1177/15459683221107893. Epub 2022 Jun 11.
PubMed 35695197Gauthier LV, Nichols-Larsen DS, Uswatte G, Strahl N, Simeo M, Proffitt R, Kelly K, Crawfis R, Taub E, Morris D, Lowes LP, Mark V, Borstad A. Video game rehabilitation for outpatient stroke (VIGoROUS): A multi-site randomized controlled trial of in-home, self-managed, upper-extremity therapy. EClinicalMedicine. 2021 Dec 17;43:101239. doi: 10.1016/j.eclinm.2021.101239. eCollection 2022 Jan.
PubMed 34977516Rafiei MH, Kelly KM, Borstad AL, Adeli H, Gauthier LV. Predicting Improved Daily Use of the More Affected Arm Poststroke Following Constraint-Induced Movement Therapy. Phys Ther. 2019 Dec 16;99(12):1667-1678. doi: 10.1093/ptj/pzz121.
PubMed 31504952
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): A Multi-center Comparative Effectiveness Trial of In-home Gamified Constraint-induced Movement Therapy for Rehabilitation of Chronic Upper Extremity Hemiparesis.
- ClinicalTrials.gov ID
- NCT02631850
- Acronym / sponsor ID
- 2012H0151
- Conditions
- Stroke, Hemiparesis
- Keywords
- Constraint-induced movement therapy, gaming, virtual reality, upper extremity, CI therapy, rehabilitation, stroke, hemiparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- OhioHealth, Providence Medical Research Center, University of Alabama at Birmingham, University of Massachusetts, Lowell, University of Missouri-Columbia
- Study start
- Nov 2015 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Posted 14 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group equating the dose of in-person therapy. Individuals with chronic stroke will be randomized to one of four different interventions: (1) traditional clinic-based CI therapy (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy (5 therapist/client contact hours in the clinic and 15 hours of independent game play at home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist contact via telerehabilitation (5 therapist/client contact hours in the clinic, 2.6 therapist contact hours via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard occupational therapy (OT) / physical therapy (PT). After 6-month follow-up, individuals assigned to standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone application of the rehabilitation game without additional therapist contact).
Detailed description
Detailed study description published in BMC Neurology (2017).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Traditional CI Therapy | Active comparator | Behavioral: Traditional CI TherapyParticipants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals. |
| Gaming CI Therapy | Active comparator | Behavioral: Gaming CI Therapy15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life. |
| Gaming CI Therapy with Additional Contact via Video Conference | Active comparator | Behavioral: Gaming CI Therapy with Additional Contact via Video ConferenceThis group will receive treatment that is identical to Group 2, but will receive an additional 2.6 hours video conference consultation throughout the treatment period. |
| Traditional Occupational Therapy/Physical Therapy | Active comparator | Behavioral: Traditional Occupational Therapy/Physical TherapyFive therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on activities of daily living (ADLs) with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of strengthening exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males, females, or any gender identity 18 years of age or older
- Experienced a stroke resulting in mild-to-moderate hemiparesis at least six months prior to enrollment (suggested range of motion (ROM) criteria includes: 45° shoulder abduction and flexion, 20° elbow extension, 20° wrist extension, and 10° extension of thumb and finger)
- Have preserved ability to comprehend and participate in basic elements of the therapy
Key exclusion criteria (4 listed)
- Concurrent participation in other experimental trials for motor dysfunction treatment
- Receiving Botox therapy currently or in the past 3 months
- Have medical conditions that would place volunteers at higher risk of adverse events (e.g., renal disease, frailty, pregnancy, dementia, severe pain, end-stage/degenerative diseases)
- Have received intensive upper-extremity rehabilitation in the chronic phase post-stroke
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 |
|---|---|---|
| Traditional CI TherapyIntensive in-person therapy for upper extremity hemiparesis. | Behavioural | Traditional CI Therapy |
| Gaming CI TherapyIntensive remote (via video game) therapy for upper extremity hemiparesis. | Behavioural | Gaming CI Therapy |
| Gaming CI Therapy with Additional Contact via Video ConferenceIntensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference. | Behavioural | Gaming CI Therapy with Additional Contact via Video Conference |
| Traditional Occupational Therapy/Physical TherapyTraditional in-person therapy focusing on the rehabilitation of the upper extremity. | Behavioural | Traditional Occupational Therapy/Physical Therapy |
Primary outcome
Wolf Motor Function Test
Time frame: 0 to 1 months
Assesses the time to complete 15 standardized tasks (e.g., folding a towel, stacking checkers, placing hand on top of a box). Items that cannot be accomplished score 120 seconds. Times are natural log transformed to reflect proportional improvement (approximate % change) and correct for skew. On the log transformed scale, -.22 reflects normal ability, 4.79 = can't accomplish task. For improvement in mean log transformed performance time, -4.79 = best possible improvement, 0 = no improvement, positive scores = worsening. A proportional improvement of 16% (mean log transformed performance time change = -.17) is considered clinically meaningful.
Motor Activity Log Quality of Movement Scale
Time frame: 0 to 1 months
Assessment evaluates the amount and quality of everyday arm use. The scale consists of 28 activities of daily living (e.g., washing hands, drinking from a cup). Participants self-report on an 11-point scale (0-5 with half-point increments, 0=not attempted to 5=attempted with normal movement). The total score on the measure reflects the mean of the individual item scores. A change of 1.0 on the scale is considered clinically meaningful.
5 secondary outcomes
Change in Neuro-Quality of Life (Neuro-QOL)
Time frame: 0 to 1 months
Bilateral Activity Monitors
Time frame: 0 to 1 month
Change in Brief Kinesthesia Test (BKT)
Time frame: 0 to 1 months
Semmes-Weinstein Monofilament Test
Time frame: 0 to 1 months
9 Hole Peg Test
Time frame: 0 to 1 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28595611Gauthier LV, Kane C, Borstad A, Strahl N, Uswatte G, Taub E, Morris D, Hall A, Arakelian M, Mark V. Video Game Rehabilitation for Outpatient Stroke (VIGoROUS): protocol for a multi-center comparative effectiveness trial of in-home gamified constraint-induced movement therapy for rehabilitation of chronic upper extremity hemiparesis. BMC Neurol. 2017 Jun 8;17(1):109. doi: 10.1186/s12883-017-0888-0.
- Derived from this study: PubMed 38406850Gauthier LV, Ravi R, DeLuca D, Zhou W. Dose Response to Upper Extremity Stroke Rehabilitation Varies by Individual: Early Indicators of Treatment Response. Stroke. 2024 Mar;55(3):696-704. doi: 10.1161/STROKEAHA.123.045039. Epub 2024 Feb 26.
- Derived from this study: PubMed 35695197Borstad A, Nichols-Larsen D, Uswatte G, Strahl N, Simeo M, Proffitt R, Gauthier L. Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Aug;36(8):525-534. doi: 10.1177/15459683221107893. Epub 2022 Jun 11.
- Derived from this study: PubMed 34977516Gauthier LV, Nichols-Larsen DS, Uswatte G, Strahl N, Simeo M, Proffitt R, Kelly K, Crawfis R, Taub E, Morris D, Lowes LP, Mark V, Borstad A. Video game rehabilitation for outpatient stroke (VIGoROUS): A multi-site randomized controlled trial of in-home, self-managed, upper-extremity therapy. EClinicalMedicine. 2021 Dec 17;43:101239. doi: 10.1016/j.eclinm.2021.101239. eCollection 2022 Jan.
- Derived from this study: PubMed 31504952Rafiei MH, Kelly KM, Borstad AL, Adeli H, Gauthier LV. Predicting Improved Daily Use of the More Affected Arm Poststroke Following Constraint-Induced Movement Therapy. Phys Ther. 2019 Dec 16;99(12):1667-1678. doi: 10.1093/ptj/pzz121.
- Individual participant dataSharing planned: Yes. Data will be made public upon publication.
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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.
Deborah Larsen, PhD principal investigator
The Ohio State U.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional CI Therapy, Gaming CI Therapy and Gaming CI Therapy with Additional Contact via Video Conference in people with Stroke and Hemiparesis, run by Ohio State University at 5 sites 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 4 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 14 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wolf Motor Function Test (time frame: 0 to 1 months). 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 NCT02631850, which also lists 5 linked publications.
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 5 Oct 2021.