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Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis

NCT04014270 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2023-05-24

No results posted yet for this study

Summary

The study aims at demonstrating the efficacy of self-modulated functional electrical stimulation (SM-FES) in promoting upper-limb (UL) motor recovery in chronic stroke patients with severe and severe-moderate paralysis.

The effect of such experimental therapy will be compared to dose-matched, goal-oriented standard care (SC).

SM-FES consists of intensive, goal-oriented, repetitive functional exercises assisted by electrical stimulation. The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand.

The duration of the intervention is 90 min per day, 5 days per week, for 2 weeks.

Conditions

  • Stroke Rehabilitation

Interventions

DEVICE

Self-modulated functional electrical stimulation (SM-FES)

The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand. A device called the Intento PRO will be used to deliver the experimental treatment. Duration: 90 min per day, 5 days per week, for 2 weeks.

OTHER

Standard Care

The patient performs intensive, goal-oriented, repetitive functional exercises. Duration: 90 min per day, 5 days per week, for 2 weeks.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • University Hospital, Geneva

    collaborator OTHER

  • KLINIK BETHESDA Tschugg

    collaborator UNKNOWN

  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER

  • University of Bern

    collaborator OTHER

  • Innosuisse - Swiss Innovation Agency

    collaborator OTHER

  • Intento SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-08
Primary Completion
2021-10-26
Completion
2023-05-22

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04014270 on ClinicalTrials.gov