Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients (RiSES)

September 27, 2018 updated by: Maurizio Ferrarin, Fondazione Don Carlo Gnocchi Onlus

Studio Clinico di Efficacia Della Stimolazione Elettrica Funzionale Controllata da Segnale Elettromiografico Nel Trattamento Dell'Arto Superiore in Pazienti Con Esiti di Ictus Cerebrovascolare (Progetto Rises)

Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke
  • at least 1 month post-stroke
  • willingness to participate the project
  • minimum voluntary muscle activation of shoulder flexors (>1 Manual Muscle Test)
  • passive Range of Motion (ROM) of the shoulder and elbow of more than 90°

Exclusion Criteria:

  • epilepsy
  • severe spasticity at upper limb (>= 3 Ashworth scale)
  • implanted electronic device
  • respiratory insufficiency
  • pregnancy
  • peripheral neuropathies
  • cutaneous ulcers at the stimulation zone
  • other use of FES on the upper limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MeCFES
25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation
Device: MeCFES-assisted task-oriented upper limb rehabilitation
ACTIVE_COMPARATOR: Control
25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation
Other: Usual Care task-oriented upper limb rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)

ARAT: Action Research Arm Test scale (15 item) (see in References section: Van der Lee JH et al 2002).

ARAT minimum value is 0 and maximum value is 45. Higher scores mean a better outcome.
5 weeks (post-treatment vs pre-treatment)
Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)

FMA-UE: Upper Extremities section of Fugl Meyer Assessment scale (see in References section: Fugl-Meyer AR et al 1975).

FMA-UE minimum value is 0 and maximum value is 66. Higher scores mean a better outcome
5 weeks (post-treatment vs pre-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)

IPPA: Individually Prioritized Problem Assessment (see in References section: Wessels R et al. 2000).

IPPA minimum value is 1 and maximum value is 25. Higher scores mean worse outcome.
5 weeks (post-treatment vs pre-treatment)
Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)
DASH: Quick version of the Disability of the Arm Shoulder and Hand questionnaire (see in References section: Kennedy et al. 2011) DASH minimum value is 0 and maximum value is 100. Higher scores mean worse outcome.
5 weeks (post-treatment vs pre-treatment)
Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment
Time Frame: 5 weeks (post-treatment vs pre-treatment)
VAS: Visual Analogic Scale for perceived pain on a 10-level scale. VAS minimum value is 0 and maximum value is 10. Higher scores mean worse outcome (more severe pain).
5 weeks (post-treatment vs pre-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

Istituto Di Ricerche Farmacologiche Mario Negri

Investigators

  • Principal Investigator: Maurizio Ferrarin, PhD, Fondazione Don Carlo Gnocchi Onlus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

November 1, 2015

Study Completion (ACTUAL)

November 1, 2015

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (ESTIMATE)

January 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RISES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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