StrokePhase 1/2DDPHme/HspNCT02882997
An Interactive Computer Game, Called Duck Duck Punch, for Stroke Rehabilitation at Home and in a Rehabilitation Clinic
A Phase 1/2 study testing an interactive computer game and standard activities in people with Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will determine the feasibility of using an interactive computer game to elicit repetitive practice of paretic arm movements in the homes of community dwelling stroke survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- an interactive computer game and standard activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Aug 2016
- Phase
- Phase 1/2
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- experienced uni-hemispheric ischemic or hemorrhagic stroke
- exhibit voluntarily shoulder flexion (affected UE) ≥20° with simultaneous elbow extension ≥10°. We reason that persons at this motor ability level have enough residual arm activation to engage in VE training
- passive range of motion in affected shoulder and elbow and within 20 degrees of normal values
- Additional inclusion criteria for community dwelling stroke survivors
- live at home
- no current rehabilitation therapy
Show all 11Show fewer
- live within a 60 minute drive of the university
- Additional inclusion criteria for inpatient stroke patients
- medically stable
- expected to remain in the hospital for the next 7 days
- able to sit in a chair for 60 minutes without difficulty
Who cannot join
- lesion in brainstem or cerebellum
- presence of other neurological disease that may impair motor skills (e.g., Parkinson's Disease)
- pain in the paretic arm that would interfere with movement
- unable to understand and follow 3-step directions
- orthopedic condition or impaired corrected vision that would interfere with reaching.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Virtual Environment for Post-Stroke Upper Extremity Rehabilitation
This study will determine the feasibility of using an interactive computer game to elicit repetitive practice of paretic arm movements in the homes of community dwelling stroke survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital.
Read the detailed description
More than 75% of the 800,000 people who annually suffer stroke exhibit persistent arm/hand hemiparesis restricting independence thus burdening caregivers. Arm motor skill can recover if the rehabilitation program provides an adequate "dose" of repetitive movement practice. However, the vast majority of stroke survivors lack the proper practice-dose because the duration of inpatient stroke rehabilitation is limited by cost, or residence in medically underserved rural settings. To meet the pressing need for innovative cost-effective rehabilitation options, the investigators developed, tested and licensed a prototype virtual environment (VE) for post-stroke arm rehabilitation. Its custom built design motivates extended practice of specific arm motor skills known to improve quality of life. Excitingly, practice sessions do not require direct therapist supervision. Published pilot data demonstrated improved real-world arm movement after VE training. These promising initial results led to software upgrades that will now enable installation and testing in the primary markets for this technology; stroke rehabilitation hospitals, and patients' homes. The overall goal for this small pilot study is to test the feasibility of self-directed VE practice in these settings measured by movement repetitions and motor skill improvement. To that end, this project will address the following Specific Aims (1) Determine the number of daily movement repetitions and treatment effect achieved by inpatients in a stroke rehabilitation hospital who self-direct VE practice sessions during non-therapy hours (evenings, weekends) compared to standard evening activities; and (2) Determine the number of daily movement repetitions and treatment effect achieved by in-home stroke survivors who self-direct daily VE practice sessions compared to a group of in-home survivors with a standard self-directed exercise program.
- Conditions
- Stroke
- Being tested
- an interactive computer game, standard activities
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an interactive computer gameBehavioural
Duck Duck Punch is an interactive computer game designed to elicit repetitive practice of paretic arm movements in stroke patients.
standard activitiesBehavioural
For community dwelling stroke survivors this is a hard copy, written/illustrated home exercise program for the paretic arm. For inpatient stroke patients this is standard recreational activities organized by the facility during non therapy hours (evenings and weekends).
| Study group | Role | What they receive |
|---|---|---|
| Duck Duck Punch | Experimental | Community dwelling stroke survivors: Stroke survivors will install an interactive computer game in their home. Subjects will be instructed to play the computer game "as much as you want to every day for 7 days." Inpatient stroke patients: The interactive computer game will be installed at a local inpatient stroke rehabilitation hospital. Subjects will be instructed to "play this game as much as you want to during non-therapy hours (evenings and weekends) over the next 7 days." Receives: Behavioral: an interactive computer game |
| Standard activities | Active comparator | Community dwelling stroke survivors: Subjects will receive a hard-copy handout of an arm home exercise program and given the instructions to "do these exercises as many times as you can daily." Inpatient stroke patients: Subjects will be encouraged to participate in standard evening/weekend recreational activities and to "remember to use the paretic arm as much as you can." Receives: Behavioral: standard activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paretic arm use
The amount of paretic arm use will be measured by wrist worn accelerometers. Subjects will be shown how to don/doff wristwatch sized triaxial Actigraph accelerometers (GT3X+ Activity Monitor; ActiGraph LLC) by securing a Velcro band on the dorsal aspect of each wrist proximal to the wrist joint. Subjects will be instructed to don the accelerometers each time they engaged in either the computer game or standard activity and wear them only for the duration of the activity. The accelerometers will be stored in a box during other times. Accelerometry data will be recorded in 1 minute epochs as the number of arm activity counts. At the final study evaluation session, data will be used to create a ratio of paretic to non-paretic arm activity counts. A value of 1 will indicate bilateral arm use, a value higher than 1 will indicate that the paretic arm was used more than the non-paretic arm, and a value less than 1 will indicate that the paretic arm was used less than the non-paretic arm.
Measured: 1 year
Secondary outcomes (3)
Fugl Meyer Upper Extremity Assessment
a 33-item measure of arm impairment testing the subject's ability to achieve various postures with the paretic arm and hand, scored on a 3 point ordinal rating scale with higher scores indicating less motor impairment.
Measured: up to 7 days
Wolf Motor Function Test
A 15-item evaluation of paretic arm motor function, testing the amount of time required for a subject to use the paretic arm to accomplish various functional tasks.
Measured: up to 7 days
Stroke Impact Scale - Hand subtest
A 5-item evaluation of patient self-reported level of difficulty using the paretic hand to perform various functional activities at home. Items are rated on a 4 point ordinal scale so that higher numbers indicate less difficulty.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startNov 2013
- Primary completionAug 2016
- Study completionAug 2016
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware
- Responsible party
- Principal investigator, Michelle Woodbury, Medical University of South Carolina
- Investigators
- Michelle L Woodbury, PhD, OTR/L, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882997
- Sponsor's protocol ID
- Pro00029185
- Acronym
- DDPHme/Hsp
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Woodbury ML, Anderson K, Finetto C, Fortune A, Dellenbach B, Grattan E, Hutchison S. Matching Task Difficulty to Patient Ability During Task Practice Improves Upper Extremity Motor Skill After Stroke: A Proof-of-Concept Study. Arch Phys Med Rehabil. 2016 Nov;97(11):1863-1871. doi: 10.1016/j.apmr.2016.03.022. Epub 2016 Apr 23.
PubMed 27117385
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Environment for Post-Stroke Upper Extremity Rehabilitation
- ClinicalTrials.gov ID
- NCT02882997
- Acronym / sponsor ID
- DDPHme/Hsp / Pro00029185
- Conditions
- Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- University of Delaware
- Study start
- Nov 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Aug 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.
This study will determine the feasibility of using an interactive computer game to elicit repetitive practice of paretic arm movements in the homes of community dwelling stroke survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital.
Detailed description
More than 75% of the 800,000 people who annually suffer stroke exhibit persistent arm/hand hemiparesis restricting independence thus burdening caregivers. Arm motor skill can recover if the rehabilitation program provides an adequate "dose" of repetitive movement practice. However, the vast majority of stroke survivors lack the proper practice-dose because the duration of inpatient stroke rehabilitation is limited by cost, or residence in medically underserved rural settings. To meet the pressing need for innovative cost-effective rehabilitation options, the investigators developed, tested and licensed a prototype virtual environment (VE) for post-stroke arm rehabilitation. Its custom built design motivates extended practice of specific arm motor skills known to improve quality of life. Excitingly, practice sessions do not require direct therapist supervision. Published pilot data demonstrated improved real-world arm movement after VE training. These promising initial results led to software upgrades that will now enable installation and testing in the primary markets for this technology; stroke rehabilitation hospitals, and patients' homes. The overall goal for this small pilot study is to test the feasibility of self-directed VE practice in these settings measured by movement repetitions and motor skill improvement. To that end, this project will address the following Specific Aims (1) Determine the number of daily movement repetitions and treatment effect achieved by inpatients in a stroke rehabilitation hospital who self-direct VE practice sessions during non-therapy hours (evenings, weekends) compared to standard evening activities; and (2) Determine the number of daily movement repetitions and treatment effect achieved by in-home stroke survivors who self-direct daily VE practice sessions compared to a group of in-home survivors with a standard self-directed exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duck Duck Punch | Experimental | Behavioral: an interactive computer gameCommunity dwelling stroke survivors: Stroke survivors will install an interactive computer game in their home. Subjects will be instructed to play the computer game "as much as you want to every day for 7 days." Inpatient stroke patients: The interactive computer game will be installed at a local inpatient stroke rehabilitation hospital. Subjects will be instructed to "play this game as much as you want to during non-therapy hours (evenings and weekends) over the next 7 days." |
| Standard activities | Active comparator | Behavioral: standard activitiesCommunity dwelling stroke survivors: Subjects will receive a hard-copy handout of an arm home exercise program and given the instructions to "do these exercises as many times as you can daily." Inpatient stroke patients: Subjects will be encouraged to participate in standard evening/weekend recreational activities and to "remember to use the paretic arm as much as you can." |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- experienced uni-hemispheric ischemic or hemorrhagic stroke
- exhibit voluntarily shoulder flexion (affected UE) ≥20° with simultaneous elbow extension ≥10°. We reason that persons at this motor ability level have enough residual arm activation to engage in VE training
- passive range of motion in affected shoulder and elbow and within 20 degrees of normal values
- Additional inclusion criteria for community dwelling stroke survivors
- live at home
Key exclusion criteria (5 listed)
- lesion in brainstem or cerebellum
- presence of other neurological disease that may impair motor skills (e.g., Parkinson's Disease)
- pain in the paretic arm that would interfere with movement
- unable to understand and follow 3-step directions
- orthopedic condition or impaired corrected vision that would interfere with reaching.
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 |
|---|---|---|
| an interactive computer gameDuck Duck Punch is an interactive computer game designed to elicit repetitive practice of paretic arm movements in stroke patients. | Behavioural | Duck Duck Punch |
| standard activitiesFor community dwelling stroke survivors this is a hard copy, written/illustrated home exercise program for the paretic arm. For inpatient stroke patients this is standard recreational activities organized by the facility during non therapy hours (evenings and weekends). | Behavioural | Standard activities |
Primary outcome
Paretic arm use
Time frame: 1 year
The amount of paretic arm use will be measured by wrist worn accelerometers. Subjects will be shown how to don/doff wristwatch sized triaxial Actigraph accelerometers (GT3X+ Activity Monitor; ActiGraph LLC) by securing a Velcro band on the dorsal aspect of each wrist proximal to the wrist joint. Subjects will be instructed to don the accelerometers each time they engaged in either the computer game or standard activity and wear them only for the duration of the activity. The accelerometers will be stored in a box during other times. Accelerometry data will be recorded in 1 minute epochs as the number of arm activity counts. At the final study evaluation session, data will be used to create a ratio of paretic to non-paretic arm activity counts. A value of 1 will indicate bilateral arm use, a value higher than 1 will indicate that the paretic arm was used more than the non-paretic arm, and a value less than 1 will indicate that the paretic arm was used less than the non-paretic arm.
3 secondary outcomes
Fugl Meyer Upper Extremity Assessment
Time frame: up to 7 days
Wolf Motor Function Test
Time frame: up to 7 days
Stroke Impact Scale - Hand subtest
Time frame: up to 7 days
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 30 Aug 2016.
- Background: PubMed 27117385Woodbury ML, Anderson K, Finetto C, Fortune A, Dellenbach B, Grattan E, Hutchison S. Matching Task Difficulty to Patient Ability During Task Practice Improves Upper Extremity Motor Skill After Stroke: A Proof-of-Concept Study. Arch Phys Med Rehabil. 2016 Nov;97(11):1863-1871. doi: 10.1016/j.apmr.2016.03.022. Epub 2016 Apr 23.
- A paper presented at a conference on the initial development of the interactive computer game.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Michelle L Woodbury, PhD, OTR/L principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing an interactive computer game and standard activities in people with Stroke, run by Medical University of South Carolina 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 11 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: finished, as of the sponsor's last update on 30 Aug 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Paretic arm use (time frame: 1 year). 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 NCT02882997, 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 30 Aug 2016.