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

Sponsor

Unity Health Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01836159

Collaborator

Sunnybrook Research Institute (Other)

Enrollment

Locations

Arms

Actual Duration (Months)

9.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fine Motor Function Deficit and Visual Neglect Post-stroke	Other: iPad Intervention Other: Standard/ Usual Care	N/A

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

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Standard/ Usual Care Patients may receive outpatient rehabilitation as required as part of usual/standard care. No experimental intervention will be given to this group.	Other: Standard/ Usual Care 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).
Experimental: iPad Intervention 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.	Other: iPad Intervention 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

Arm

Intervention/Treatment

Other: Standard/ Usual Care

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

Other: Standard/ Usual Care

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).

Experimental: iPad Intervention

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.

Other: iPad Intervention

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

Outcome Measures

Primary Outcome Measures

Total "dose" of intervention received as a proportion of the scheduled time [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).

Secondary Outcome Measures

Efficacy in fine motor function skills [3 business days after final study intervention session]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5
2	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
3	Toronto Rehabilitation Institute	Toronto	Ontario	Canada	M5G 2A2