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

NCT01836159 | Completed

• 1 other identifier: 13-059C
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Fine Motor Function Deficit and Visual Neglect Post-stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  10 days over a 2 week period

Secondary Outcomes (1)

• Efficacy in fine motor function skills

  3 business days after final study intervention session

Study Arms (2)

Standard/ Usual Care

OTHER

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

iPad Intervention

EXPERIMENTAL

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

Interventions

iPad Intervention OTHER

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

iPad Intervention

Standard/ Usual Care OTHER

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).

Standard/ Usual Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any medical condition that might confound the interpretation of results or put the patient at risk

Sponsors & Collaborators

• Unity Health Toronto: lead
• Sunnybrook Research Institute: collaborator

Study Sites (3)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, M5G 2A2, Canada

Location

Related Publications (1)

• 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.

  PMID: 25042159 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Tom Schweizer, PhD

  Li Ka Shing, St Michael's Hospital

  STUDY DIRECTOR

• Chi-Ming Chow, MD

  Unity Health Toronto

  STUDY DIRECTOR

• Gustavo Saposnik, MD, MSc

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 19, 2013
• Study Start: June 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

CA (3)