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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by St. Michael's Hospital, Toronto
Sponsor:
Collaborator:
Sunnybrook Research Institute
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT01836159
First received: April 16, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention
Fine Motor Function Deficit and Visual Neglect Post-stroke
Other: iPad Intervention
Other: Standard/ Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic

Resource links provided by NLM:


Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Total "dose" of intervention received as a proportion of the scheduled time [ Time Frame: 10 days over a 2 week period ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 business days after final study intervention session ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01836159

Contacts
Contact: Avon Saldanha 416-864-6060 ext 7879 SaldanhaA@smh.ca
Contact: Alice Dang 416-864-6060 ext 77055 danga@smh.ca

Locations
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Gustavo Saposnik, MD         
Principal Investigator: Chi-Ming Chow, MD         
Principal Investigator: Tom Schweizer, PhD         
Sunnybrook Health Sciences Centre Active, not recruiting
Toronto, Ontario, Canada, M4N 3M5
Toronto Rehabilitation Institute Not yet recruiting
Toronto, Ontario, Canada, M5G 2A2
Principal Investigator: Mark Bayley, MD         
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Sunnybrook Research Institute
Investigators
Study Director: Tom Schweizer, PhD Li Ka Shing, St Michael's Hospital
Study Director: Chi-Ming Chow, MD St. Michael's Hospital, Toronto
Principal Investigator: Gustavo Saposnik, MD, MSc St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT01836159     History of Changes
Other Study ID Numbers: 13-059C
Study First Received: April 16, 2013
Last Updated: February 4, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by St. Michael's Hospital, Toronto:
Stroke Rehabilitation
iPad
Fine Motor Function
Ischemic Stroke
Visual Neglect

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 22, 2014