iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic
|ClinicalTrials.gov Identifier: NCT01836159|
Recruitment Status : Unknown
Verified November 2015 by St. Michael's Hospital, Toronto.
Recruitment status was: Recruiting
First Posted : April 19, 2013
Last Update Posted : November 17, 2015
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|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||March 2016|
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:
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836159
|Contact: Avon Saldanha||416-864-6060 ext 7879||SaldanhaA@smh.ca|
|Contact: Alice Dang||416-864-6060 ext firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Active, not recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|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|
|Toronto Rehabilitation Institute||Not yet recruiting|
|Toronto, Ontario, Canada, M5G 2A2|
|Principal Investigator: Mark Bayley, MD|
|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|