Clinical Trials Directory

Trials / Completed

CompletedNCT01836159

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
29 (actual)
Sponsor
Unity Health Toronto · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
OTHERiPad InterventionPatients 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
OTHERStandard/ Usual CarePatients 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).

Timeline

Start date
2014-06-01
Primary completion
2017-03-01
Completion
2018-03-01
First posted
2013-04-19
Last updated
2019-10-01

Locations

3 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT01836159. Inclusion in this directory is not an endorsement.