Encouragement-induced Movement Therapy in Daily Life

Stroke Clinical Trial

— ISEAR  

Official title:

Encouragement-induced Movement Therapy in Daily Life - a Randomized Controlled, Assessor-blinded Multi-center Trial in Stroke Patients With a Unilateral Hemiparesis, Using a Wrist-worn Tracking and Feedback Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03294187
• Other study ID #: 2017-00948
• Status: Completed
• Phase: N/A
• Start date: September 25, 2017
• Est. completion date: November 25, 2021

Study information

• Verified date: November 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 25, 2021
• Est. primary completion date: November 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Above 18 years of age with unilateral stroke and residual hemiparesis leading to a decrease of arm function after completion of all inpatient rehabilitation (at least 90 days post stroke)
• Ability to lift arm against gravity (>30 degrees flexion or abduction)
• Ability to don/doff the devices on both wrists independently or with assistance of a caregiver
• Ability to give informed consent as documented by signature

Exclusion Criteria:

• Major untreated depression
• Severe cognitive impairment
• Suffering from comprehensive aphasia
• Severely impaired sensation (unable to feel a soft touch on the dorsal side of their paretic wrist with closed eyes)
• Other major comorbidities (e.g., cardiopulmonary disease, renal failure, hepatic dysfunction, orthopedic disorders, etc.)
• Expected hospitalization during study period
• Known intolerance to device material
• Known or suspected non-compliance, drug or alcohol abuse
• The investigator, his/her family members, employees, and other dependent persons

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Wrist-worn wearables
See arm/group description.

Locations

Country	Name	City	State
Switzerland	Cereneo, Center For Neurology and Rehabilitation	Vitznau
Switzerland	Zürcher RehaZentrum Wald	Wald
Switzerland	University Hospital Zurich	Zürich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Swiss Federal Institute of Technology in Zurich (ETH Zurich), Tyromotion AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Global Rating of Perceived Change		Post-intervention (6 weeks)
Other	Global Rating of Perceived Change		Follow-up (12 weeks)
Other	Concomitant movement therapy	Time spend at Movement therapy (e.g., Physiotherapy, Occupational therapy)	Post-intervention (6 weeks)
Other	Concomitant movement therapy		Follow-up (12 weeks)
Other	Adverse Events	Safety	Baseline (0 week)
Other	Adverse Events	Safety	Post-intervention (6 weeks)
Other	Adverse Events	Safety	Follow-up (12 weeks)
Primary	Motor Activity Log - 14, Amount of Use sub scale	Self-reported amount of upper limb use in daily life	Post-intervention (6 weeks)
Secondary	Fugl-Meyer Assessment, Upper Extremity sub scale	Upper limb motor function	Post-intervention (6 weeks)
Secondary	Fugl-Meyer Assessment, Upper Extremity sub scale	Upper limb motor function	Follow-up (12 weeks)
Secondary	Action Research Arm Test	Upper limb capacity	Post-intervention (6 weeks)
Secondary	Action Research Arm Test	Upper limb capacity	Follow-up (12 weeks)
Secondary	Modified Rankin Scale	Global Disability	Post-intervention (6 weeks)
Secondary	Modified Rankin Scale	Global Disability	Follow-up (12 weeks)
Secondary	EuroQol five dimensions five levels questionnaire	Quality of Life	Post-intervention (6 weeks)
Secondary	EuroQol five dimensions five levels questionnaire	Quality of Life	Follow-up (12 weeks)
Secondary	Motor Activity Log - 14, Quality of Movement sub scale	Self-reported quality of upper limb use in daily life	Post-intervention (6 weeks)
Secondary	Motor Activity Log - 14, Quality of Movement sub scale	Self-reported quality of upper limb use in daily life	Follow-up (12 weeks)
Secondary	Motor Activity Log - 14, Amount of Use sub scale	Self-reported amount of upper limb use in daily life	Follow-up (12 weeks)