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

• ClinicalTrials.gov Identifier: NCT01836159
• Recruitment Status: Completed
• First Posted: April 19, 2013
• Last Update Posted: October 1, 2019
• Sponsor: Unity Health Toronto
• Collaborator: Sunnybrook Research Institute
• Information provided by (Responsible Party): Unity Health Toronto

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	Not Applicable

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 (Clinical Trial)
• 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: June 2014
• Actual Primary Completion Date: March 2017
• Actual Study Completion Date: March 2018

Arms and Interventions

Arm	Intervention/treatment
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 :

1. 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).

Secondary Outcome Measures :

1. Efficacy in fine motor function skills [ Time Frame: 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

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Ontario

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

St. Michael's Hospital

Toronto, Ontario, Canada, M5B 1W8

Toronto Rehabilitation Institute

Toronto, Ontario, Canada, M5G 2A2

Sponsors and Collaborators

Unity Health Toronto

Sunnybrook Research Institute

Investigators

• Study Director: Tom Schweizer, PhD; Li Ka Shing, St Michael's Hospital
• Study Director: Chi-Ming Chow, MD; Unity Health Toronto
• Principal Investigator: Gustavo Saposnik, MD, MSc; Unity Health Toronto

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT01836159
• Other Study ID Numbers: 13-059C
• First Posted: April 19, 2013
• Last Update Posted: October 1, 2019
• Last Verified: September 2019

Keywords provided by Unity Health Toronto:

Stroke Rehabilitation; iPad; Fine Motor Function; Ischemic Stroke; Visual Neglect

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases