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

September 30, 2019 updated by: Unity Health Toronto

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Toronto, Ontario, Canada, M5G 2A2
        • Toronto Rehabilitation Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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:

  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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 days over a 2 week period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 business days after final study intervention session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2014

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2018

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (ESTIMATE)

April 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-059C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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