Encouragement-induced Movement Therapy in Daily Life "ISEAR"

Not yet recruiting

Phase 2 Results N/A

Trial Description

Stroke places a major burden on health care and society. It often leads to a hemiparesis. Intensive stroke rehabilitation speeds up recovery. In daily practice, the financial and/or human resources to provide this intensive rehabilitation are often lacking. Applying modern-day tracking and feedback technology to encourage a self-administered, context specific training is expected to offer significant potential to increase intensity of practice. Up until now, there has been no randomized trial examining the effect of such an intervention on daily arm usage.
The primary objective of this study is to determine the effect of wearing an activity tracking and multimodal feedback device for six weeks on self-reported daily life use of the paretic arm after stroke, when compared to control group stroke subjects wearing a hardware-wise identical sham device providing no feedback. The secondary aim is to examine compliance to use the device and the quantitative, qualitative and functional improvement of the paretic arm. It is hypothesized that participants in the experimental group show a higher change in self-reported daily life use of the paretic arm when compared to the control group both post intervention and at 6-week follow-up.
ISEAR is a multicenter, assessor-blinded randomized controlled trial of 62 subjects beyond the first 3 months poststroke.

Conditions

Interventions

  • Wrist-worn wearables Device
    Intervention Desc: See arm/group description.
    ARM 1: Kind: Experimental
    Label: Monitoring and Feedback
    Description: Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback.
    ARM 2: Kind: Experimental
    Label: Monitoring
    Description: Study subjects will use identical devices over a period of 6 weeks. Patients will *not* receive multimodal feedback.

Outcomes

Type Measure Time Frame Safety Issue
Primary Motor Activity Log - 14, Amount of Use sub scale Post-intervention (6 weeks)
Secondary Fugl-Meyer Assessment, Upper Extremity sub scale Post-intervention (6 weeks)
Secondary Action Research Arm Test Post-intervention (6 weeks)
Secondary Modified Rankin Scale Post-intervention (6 weeks)
Secondary EuroQol five dimensions five levels questionnaire Post-intervention (6 weeks)
Secondary Motor Activity Log - 14, Quality of Movement sub scale Post-intervention (6 weeks)

Sponsors