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.
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).
- IPad Intervention Other
Intervention Desc: 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 ARM 1: Kind: Experimental Label: iPad Intervention 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.
- Standard/ Usual Care Other
Intervention Desc: 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). ARM 1: Kind: Experimental Label: Standard/ Usual Care Description: Patients may receive outpatient rehabilitation as required as part of usual/standard care. No experimental intervention will be given to this group.
- Allocation: Randomized
- Masking: Single Blind (Outcomes Assessor)
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Total "dose" of intervention received as a proportion of the scheduled time||10 days over a 2 week period||No|
|Secondary||Efficacy in fine motor function skills||3 business days after final study intervention session||No|