Fine Motor Function Deficit and Visual Neglect Post-strokeNCT01836159
iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic
A study testing iPad Intervention in people with Fine Motor Function Deficit and Visual Neglect Post-stroke, run by Unity Health Toronto at 3 sites in Canada.
Trial summary
A pilot randomized, two parallel group study comparing an iPad software game application versus standard care in post-stroke patients. Study hypothesis: Tablet PC technology using the iPad is a feasible and potentially efficacious tool which has the potential to promote fine motor recovery of the upper extremity after… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Fine Motor Function Deficit and Visual Neglect Post-stroke
- What is being tested?
- iPad Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesCanada
- Study dates
- Jun 2014to Mar 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has provided written consent prior to entry into the study
- Males or females, 18 - 85 years of age
- Evidence of ischemic or hemorrhagic stroke confirmed by CT or MRI head scan
- Patient with onset of symptoms less than 3 months (for iHOME Acute) or patient more than 6 months (for iHOME Chronic) at the time of randomization
- Measurable deficit of the upper extremity ≥3 according to the Chedoke McMaster scale e.g. participants should be able to touch their chin and contralateral knee to be eligible (for iHome Acute), or measurable deficit of the upper extremity ≥4 according to the Chedoke McMaster scale e.g. participants should be able to touch their chin and contralateral knee to be eligible (for iHome Chronic)
- Functional independence prior to present stroke (mRS = 0-1)
- Patient is alert, medically stable according to the treating physician and able to follow simple verbal commands
Who cannot join
- Patient had stroke onset more than 3 months ago (for iHOME Acute) or patient had stroke onset less than 6 months ago (for iHOME Chronic)
- Inability to follow verbal commands or having global aphasia
- Severe illness with life expectancy less than 3 months
- Uncontrolled hypertension, unstable angina, or recent myocardial infarction
- History of seizures
- Participation in another clinical trial involving rehabilitation or investigational drug
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- Unable to comply with the protocol
- Patient has any condition(s) that would warrant exclusion from the study
- Any medical condition that might confound the interpretation of results or put the patient at risk
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto Rehabilitation Institute
Toronto, Ontario, M5G 2A2
About this study
A pilot randomized, two parallel group study comparing an iPad software game application versus standard care in post-stroke patients.
Study hypothesis: Tablet PC technology using the iPad is a feasible and potentially efficacious tool which has the potential to promote fine motor recovery of the upper extremity after stroke.
Read the detailed description
The standard one hour of out-patient rehabilitation is insufficient in providing the repetitive intense training required for rehabilitation of fine motor recovery. There are also limited interventions are available for home use after discharge from a rehabilitation centre. Hence, there is now a need to determine the feasibility of innovative strategies for home use, to cover the gap after discharge from rehabilitation institutions.
iHOME is an original, low cost, potentially high impact intervention to fulfil this gap. If proven to be effective, the use of tablet technology has a broad range of potential outcomes and benefits. The anticipated public benefit is for stroke patients to be able to potentially employ the iPad, an accessible technological device, as an expansion of rehabilitation in an in-home setting.
iHOME is a pilot randomized controlled trial with a blinded outcome assessment. The trial is subdivided into iHOME Acute and iHOME Chronic, where patients have had a stroke less than 3 months or more than 6 months ago, respectively, at the time of randomization. Participants will be randomly allocated in a 1:1 ratio to the interventions arms (i.e. the investigational and control group).
- Being tested
- iPad Intervention, Standard/ Usual Care
- Keywords
- Stroke Rehabilitation, iPad, Fine Motor Function, Ischemic Stroke, Visual Neglect
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad InterventionOther
Patients are to self-administer 20 minutes of gaming sessions, in any configuration that is preferred. Patients will be instructed to play the iPad game with the more affected arm/hand. Start and stop times of the iPad intervention will be downloaded from the iPad, which will allow calculation of the total "dose" received. Patients may receive outpatient rehabilitation as required as part of usual care.
The 'Stroke Rehab' software for the iPad was specifically designed for patients with either fine motor weakness and/or neglect. It contains 6 stages:
- Popping a stationary balloon
- Popping a moving balloon
- Popping a pair of stationary balloons
- Popping a pair of moving balloons
- Stretching a balloon to pop
- Balloon/Text distraction test
Standard/ Usual CareOther
Patients may receive outpatient rehabilitation as required as part of usual care. Patients will be instructed not to play with an iPad during the 2 week intervention period (in case they have one).
| Study group | Role | What they receive |
|---|---|---|
| Standard/ Usual Care | Other | Patients may receive outpatient rehabilitation as required as part of usual/standard care. No experimental intervention will be given to this group. Receives: Other: Standard/ Usual Care |
| iPad Intervention | Experimental | Patients randomized to the iPad arm will be instructed to self-administer 20 minutes of game sessions per day for 10 days over a 2 week (14 day) period. Receives: Other: iPad Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total "dose" of intervention received as a proportion of the scheduled time
The maximum total dose of intervention is 200min (20 min/day x 10 days). A 70% received intervention (≥140 min) from the total scheduled time will be considered successful. This will be measured by the amount of time the patient uses the application (this data is stored in the application).
Measured: 10 days over a 2 week period
Secondary outcomes (1)
Efficacy in fine motor function skills
Efficacy will be measured by an improvement in the time to complete the nine-hole-peg test; the time to magnify and pop the balloons in the iPad software application as determined by the iPad score; the number of fine motor tasks that participants completed on the Wolf Motor Function Test; and an improvement on the Box and Block Test in the post-intervention visit. Efficacy in visual neglect will be measured by an improvement in the Star Cancellation or Line Bisection Test.
Measured: 3 business days after final study intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startJun 2014
- Primary completionMar 2017
- Study completionMar 2018
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 Fine Motor Function Deficit and Visual Neglect Post-strokeStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Responsible party
- Sponsor
- Investigators
- Tom Schweizer, PhD, Study director, Li Ka Shing, St Michael's HospitalChi-Ming Chow, MD, Study director, Unity Health TorontoGustavo Saposnik, MD, MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836159
- Sponsor's protocol ID
- 13-059C
- Status last verified
- Sep 2019
- First submitted
- 16 Apr 2013
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Saposnik G, Chow CM, Gladstone D, Cheung D, Brawer E, Thorpe KE, Saldanha A, Dang A, Bayley M, Schweizer TA; iHOME Research Team for the Stroke Outcomes Research Canada Working Group. iPad technology for home rehabilitation after stroke (iHOME): a proof-of-concept randomized trial. Int J Stroke. 2014 Oct;9(7):956-62. doi: 10.1111/ijs.12328. Epub 2014 Jul 7.
PubMed 25042159
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic
- ClinicalTrials.gov ID
- NCT01836159
- Acronym / sponsor ID
- 13-059C
- Keywords
- Stroke Rehabilitation, iPad, Fine Motor Function, Ischemic Stroke, Visual Neglect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Study start
- Jun 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 19 Apr 2013 (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.
A pilot randomized, two parallel group study comparing an iPad software game application versus standard care in post-stroke patients.
Study hypothesis: Tablet PC technology using the iPad is a feasible and potentially efficacious tool which has the potential to promote fine motor recovery of the upper extremity after stroke.
Detailed description
The standard one hour of out-patient rehabilitation is insufficient in providing the repetitive intense training required for rehabilitation of fine motor recovery. There are also limited interventions are available for home use after discharge from a rehabilitation centre. Hence, there is now a need to determine the feasibility of innovative strategies for home use, to cover the gap after discharge from rehabilitation institutions.
iHOME is an original, low cost, potentially high impact intervention to fulfil this gap. If proven to be effective, the use of tablet technology has a broad range of potential outcomes and benefits. The anticipated public benefit is for stroke patients to be able to potentially employ the iPad, an accessible technological device, as an expansion of rehabilitation in an in-home setting.
iHOME is a pilot randomized controlled trial with a blinded outcome assessment. The trial is subdivided into iHOME Acute and iHOME Chronic, where patients have had a stroke less than 3 months or more than 6 months ago, respectively, at the time of randomization. Participants will be randomly allocated in a 1:1 ratio to the interventions arms (i.e. the investigational and control group).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard/ Usual Care | Other | Other: Standard/ Usual CarePatients may receive outpatient rehabilitation as required as part of usual/standard care. No experimental intervention will be given to this group. |
| iPad Intervention | Experimental | Other: iPad InterventionPatients randomized to the iPad arm will be instructed to self-administer 20 minutes of game sessions per day for 10 days over a 2 week (14 day) period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient has provided written consent prior to entry into the study
- Males or females, 18 - 85 years of age
- Evidence of ischemic or hemorrhagic stroke confirmed by CT or MRI head scan
- Patient with onset of symptoms less than 3 months (for iHOME Acute) or patient more than 6 months (for iHOME Chronic) at the time of randomization
- Measurable deficit of the upper extremity ≥3 according to the Chedoke McMaster scale e.g. participants should be able to touch their chin and contralateral knee to be eligible (for iHome Acute), or measurable deficit of the upper extremity ≥4 according to the Chedoke McMaster scale e.g. participants should be able to touch their chin and contralateral knee to be eligible (for iHome Chronic)
Key exclusion criteria (9 listed)
- Patient had stroke onset more than 3 months ago (for iHOME Acute) or patient had stroke onset less than 6 months ago (for iHOME Chronic)
- Inability to follow verbal commands or having global aphasia
- Severe illness with life expectancy less than 3 months
- Uncontrolled hypertension, unstable angina, or recent myocardial infarction
- History of seizures
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 |
|---|---|---|
| iPad InterventionPatients are to self-administer 20 minutes of gaming sessions, in any configuration that is preferred. Patients will be instructed to play the iPad game with the more affected arm/hand. Start and stop times of the iPad intervention will be downloaded from the iPad, which will allow calculation of the total "dose" received. Patients may receive outpatient rehabilitation as required as part of usual care. The 'Stroke Rehab' software for the iPad was specifically designed for patients with either fine motor weakness and/or neglect. It contains 6 stages: 1. Popping a stationary balloon 2. Popping a moving balloon 3. Popping a pair of stationary balloons 4. Popping a pair of moving balloons 5. Stretching a balloon to pop 6. Balloon/Text distraction test | Other | iPad Intervention |
| Standard/ Usual CarePatients may receive outpatient rehabilitation as required as part of usual care. Patients will be instructed not to play with an iPad during the 2 week intervention period (in case they have one). | Other | Standard/ Usual Care |
Primary outcome
Total "dose" of intervention received as a proportion of the scheduled time
Time frame: 10 days over a 2 week period
The maximum total dose of intervention is 200min (20 min/day x 10 days). A 70% received intervention (≥140 min) from the total scheduled time will be considered successful. This will be measured by the amount of time the patient uses the application (this data is stored in the application).
1 secondary outcome
Efficacy in fine motor function skills
Time frame: 3 business days after final study intervention session
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 1 Oct 2019.
- Derived from this study: PubMed 25042159Saposnik G, Chow CM, Gladstone D, Cheung D, Brawer E, Thorpe KE, Saldanha A, Dang A, Bayley M, Schweizer TA; iHOME Research Team for the Stroke Outcomes Research Canada Working Group. iPad technology for home rehabilitation after stroke (iHOME): a proof-of-concept randomized trial. Int J Stroke. 2014 Oct;9(7):956-62. doi: 10.1111/ijs.12328. Epub 2014 Jul 7.
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.
Tom Schweizer, PhD study director
Li Ka Shing, St Michael's Hospital
Chi-Ming Chow, MD study director
Unity Health Toronto
Gustavo Saposnik, MD, MSc principal investigator
Unity Health Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPad Intervention in people with Fine Motor Function Deficit and Visual Neglect Post-stroke, run by Unity Health Toronto at 3 sites in Canada.
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 7 inclusion and 9 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 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Total "dose" of intervention received as a proportion of the scheduled time (time frame: 10 days over a 2 week period). 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 NCT01836159, 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 1 Oct 2019.