Clinical trial NCT01836159: iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic
Official title: iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fine Motor Function Deficit and Visual Neglect Post-stroke
Keywords: Stroke Rehabilitation
iPad
Fine Motor Function
Ischemic Stroke
Visual Neglect
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Research Institute
First posted: 2013-04-19
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Total "dose" of intervention received as a proportion of the scheduled time
timeFrame: 10 days over a 2 week period
Secondary outcomes:
measure: Efficacy in fine motor function skills
timeFrame: 3 business days after final study intervention session
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: Li Ka Shing, St Michael's Hospital
name: Tom Schweizer, PhD
role: STUDY_DIRECTOR
affiliation: Unity Health Toronto
name: Chi-Ming Chow, MD
role: STUDY_DIRECTOR
affiliation: Unity Health Toronto
name: Gustavo Saposnik, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.