Encouragement-induced Movement Therapy in Daily Life

NCT03294187 | Completed

• 1 other identifier: 2017-00948
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Stroke

Keywords

Upper Extremity; Feedback; Rehabilitation; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Motor Activity Log - 14, Amount of Use sub scale

  Self-reported amount of upper limb use in daily life

  Post-intervention (6 weeks)

Secondary Outcomes (11)

• Fugl-Meyer Assessment, Upper Extremity sub scale

  Post-intervention (6 weeks)

• Fugl-Meyer Assessment, Upper Extremity sub scale

  Follow-up (12 weeks)

• Action Research Arm Test

  Post-intervention (6 weeks)

• Action Research Arm Test

  Follow-up (12 weeks)

• Modified Rankin Scale

  Post-intervention (6 weeks)

Other Outcomes (7)

• Global Rating of Perceived Change

  Post-intervention (6 weeks)

• Global Rating of Perceived Change

  Follow-up (12 weeks)

• Concomitant movement therapy

  Post-intervention (6 weeks)

Study Arms (2)

Monitoring and Feedback

EXPERIMENTAL

Subjects will use two wrist-worn wearables over a period of 6 weeks. Patients will receive multimodal (vibrotactile and visual) feedback.

Device: Wrist-worn wearables

Monitoring

PLACEBO COMPARATOR

Study subjects will use identical devices over a period of 6 weeks. Patients will \*not\* receive multimodal feedback.

Device: Wrist-worn wearables

Interventions

Wrist-worn wearables DEVICE

See arm/group description.

Monitoring; Monitoring and Feedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Tyromotion AG: collaborator
• Swiss Federal Institute of Technology in Zurich (ETH Zurich): collaborator

Study Sites (3)

Cereneo, Center For Neurology and Rehabilitation

Vitznau, Switzerland

Location

Zürcher RehaZentrum Wald

Wald, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (2)

• Mayrhuber L, Andres SD, Legrand ML, Luft AR, Ryser F, Gassert R, Veerbeek JM, Duinen JV, Schwarz A, Franinovic K, Rickert C, Schkommodau E, O Held JP, Easthope CA, Lambercy O. Encouraging arm use in stroke survivors: the impact of smart reminders during a home-based intervention. J Neuroeng Rehabil. 2024 Dec 21;21(1):220. doi: 10.1186/s12984-024-01527-2.

  PMID: 39707385 DERIVED

• Held JPO, Luft AR, Veerbeek JM. 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. Front Neurol. 2018 Jan 25;9:13. doi: 10.3389/fneur.2018.00013. eCollection 2018.

  PMID: 29422881 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andreas R Luft, Prof. MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 26, 2017
• Study Start: September 25, 2017
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)