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

Primary Purpose

Fine Motor Function Deficit and Visual Neglect Post-stroke

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

iPad Intervention

Standard/ Usual Care

About this trial

This is an interventional other trial for Fine Motor Function Deficit and Visual Neglect Post-stroke focused on measuring Stroke Rehabilitation, iPad, Fine Motor Function, Ischemic Stroke, Visual Neglect

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sunnybrook Health Sciences Centre
St. Michael's Hospital
Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard/ Usual Care

iPad Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

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

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.

Full Information

NCT ID

NCT01836159

First Posted

April 16, 2013

Last Updated

September 30, 2019

Sponsor

Unity Health Toronto

Collaborators

Sunnybrook Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01836159

Brief Title

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

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 2014 (Actual)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

Collaborators

Sunnybrook Research Institute

4. Oversight

Data Monitoring Committee

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fine Motor Function Deficit and Visual Neglect Post-stroke

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard/ Usual Care

Arm Type

Other

Arm Description

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

Arm Title

iPad Intervention

Arm Type

Experimental

Arm 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.

Intervention Type

Other

Intervention Name(s)

iPad Intervention

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard/ Usual Care

Intervention Description

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).

Primary Outcome Measure Information:

Title

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

Description

Time Frame

10 days over a 2 week period

Secondary Outcome Measure Information:

Title

Efficacy in fine motor function skills

Description

Time Frame

3 business days after final study intervention session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tom Schweizer, PhD

Organizational Affiliation

Li Ka Shing, St Michael's Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Chi-Ming Chow, MD

Organizational Affiliation

Unity Health Toronto

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Gustavo Saposnik, MD, MSc

Organizational Affiliation

Unity Health Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Facility Name

Toronto Rehabilitation Institute

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2A2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25042159

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.

Results Reference

derived

Learn more about this trial

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

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