NCT03294187: ISEAR

Encouragement-induced Movement Therapy in Daily Life

Completed NA Last updated 8 December 2021

What this trial tests

NA trial testing Wrist-worn wearables in Stroke in 42 participants. Completed in 25 November 2021.

Timeline

25 September 2017

Primary endpoint
25 November 2021

25 November 2021

Quick facts

Lead sponsor	University of Zurich
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	42
Start date	25 September 2017
Primary completion	25 November 2021
Estimated completion	25 November 2021
Sites	3 locations across Switzerland

Drugs / interventions tested

• Wrist-worn wearables

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

University of Zurich

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Encouragement-Induced Real-World Upper Limb Use after Stroke by a Tracking and Feedback Device: A Study Protocol for a Multi-Center, Assessor-Blinded, Randomized Controlled Trial.
   Held JPO, Luft AR, Veerbeek JM. · · 2018 · cited 14× · PMID 29422881 · DOI 10.3389/fneur.2018.00013
2. The association between dexterity and upper limb impairment during stroke recovery.
   Valladares B, Kundert RG, Pohl J, Held JPO, et al · · 2024 · cited 3× · PMID 39224885 · DOI 10.3389/fneur.2024.1429929
3. Encouraging arm use in stroke survivors: the impact of smart reminders during a home-based intervention.
   Mayrhuber L, Andres SD, Legrand ML, Luft AR, et al · · 2024 · cited 2× · PMID 39707385 · DOI 10.1186/s12984-024-01527-2
4. Encouraging Arm Use in Stroke Survivors: The Impact of Smart Reminders during a Home-Based Intervention
   Mayrhuber L, Andres SD, Legrand ML, Luft AR, et al · · 2024 · DOI 10.21203/rs.3.rs-5002284/v1
5. European Stroke Organisation Conference: Late Breaking Abstracts
   · 2018