Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-30 @ 8:36 PM
Study NCT ID:
NCT01836159
Status:
COMPLETED
Last Update Posted:
2019-10-01
First Post:
2013-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic
Sponsor:
Unity Health Toronto
Organization:
Study Overview
Official Title:
iPad Technology for HOME Rehabilitation in Patients After Stroke: iHOME Acute/Chronic
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: