iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic

Unity Health Toronto

Status: Completed

Conditions: Fine Motor Function Deficit and Visual Neglect Post-stroke

Treatments: Other: iPad Intervention; Other: Standard/ Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01836159

13-059C

Details and patient eligibility

About

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.

Full 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).

Enrollment: 29 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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29 participants in 2 patient groups

Standard/ Usual Care

Other group

Description:

Patients may receive outpatient rehabilitation as required as part of usual/standard care. No experimental intervention will be given to this group.

Treatment:

Other: Standard/ Usual Care

iPad Intervention

Experimental group

Description:

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.

Treatment:

Other: iPad Intervention