Study on the Effects of an EMG-controlled Functional Electrical Stimulator for Upper Limb for Post-stroke Patients

NCT06928857 | Recruiting DMC

• 1 other identifier: RAISE-FITFES-RCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

Upper limb disabilities are among the most debilitating issues after a cerebral stroke. One promising approach in motor rehabilitation is the use of functional electrical stimulation (FES). This technique can be integrated into daily therapy to follow an adaptive approach, exploiting the residual capacities of patients. FES can help to stimulate the affected muscles, improve coordination and strengthen the weakened muscles, thus supporting the rehabilitation process.

Conditions

Stroke

Keywords

EMG-controlled Functional Electrical Stimulation; Stroke rehabilitation; Medical device

Outcome Measures

Primary Outcomes (4)

• Action Research Arm Test (ARAT)

  The ARAT test assesses upper limb functioning through the execution of 19 tasks, divided in 4 sub-tests (grasp, grip, pinch, and gross arm movement). Each movement is scored on a 4-point ordinal scale (0=no movement, 1=movement partially performed, 2=movement completed but takes abnormally long; 3=movement performed normally). Total possible score is 57 points, with higher scores associated to best motor functioning.

  Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)

• Fugl-Meyer Upper Extremity scale (FM-UE)

  The Fugl-Meyer Assessment of Motor Recovery after Stroke is one of the most widely used measures of motor impairment in post-stroke hemiplegic patients, covering 5 domains (Motor fu ENnction, sensory function, balance, joint range of motion, joint pain). The assessment of upper extremity motion is performed using the Upper Extremity assessment (FM-UE), including items scored on a 3-point ordinal scale (0: cannot perform, 1: performs partially; 2: performs fully) with a total maximum score: 66 points (higher scores, best clinical profile).

  Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)

• Box and Block test (BBT)

  The Box and Block Test (BBT) measures unilateral gross manual dexterity. The BBT goal is to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The score is determined by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Higher scores on the test indicate better gross manual dexterity

  Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)

• EuroQol 5-Dimension 5-level (EQ-5D-5L) Questionnaire

  EQ-5D-5L is a standardized instrument for use as a measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, the EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status. It measures the 5 dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension is scored on a Likert scale of 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

  Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)

Secondary Outcomes (4)

• Surface Electromyography (EMGs)

  Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)

• Body Kinematics

  Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1)

• Treatment Safety

  After 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)

• Cost-effectiveness ratio

  At the end of 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)

Other Outcomes (3)

• Age data

  Baseline (T0)

• Gender data

  Baseline (T0)

• Scholarity data

  Baseline (T0)

Study Arms (2)

FES group

EXPERIMENTAL

Subjects will use the device as need-based support to perform task-oriented exercises

Device: EMG-based FES rehabilitation

CON group

ACTIVE COMPARATOR

Subjects will perform task-oriented exercises without the support of the device

Other: Traditional rehabilitation

Interventions

EMG-based FES rehabilitation DEVICE

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises while using the FitFES device.

FES group

Traditional rehabilitation OTHER

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency. Each participant will perform task-oriented exercises.

CON group

Eligibility Criteria

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

You may qualify if:

• years or older
• Diagnosis of first ischemic or hemorrhagic unilateral stroke for at least two weeks
• Medical Research Council score for at least one upper limb muscle greater than 0 and less than 5 (excluding extremes).
• Signed informed consent

You may not qualify if:

• Score at the Mini Mental State Examination (adjusted for age and schooling) \< 24
• Clinical evidence in the case of visual disturbance, ideomotor apraxia, behavioral disorders, neglect, sensory, visual and auditory disturbances of severe degree or otherwise that prevent use of the device
• Major head trauma
• Cardio-respiratory or internal clinical instability
• State of pregnancy or lactation
• Severe spasticity (Ashworth \> 3)
• Skin integrity problems at the interface surface with the device
• Implanted electronic devices
• Epilepsy not medically controlled
• Severe peripheral neuropathy
• Recent interventions
• Thrombosis, thrombophlebitis
• Active stent carrier less than six months
• Severe forms of arteriosclerosis, arterial circulatory disorders
• Hypertension not treated

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead
• Istituto Italiano di Tecnologia: collaborator
• Ospedale Policlinico San Martino: collaborator

Study Sites (3)

Ospedale Policlinico San Martino

Genova, 16132, Italy

RECRUITING

Fondazione Don Carlo Gnocchi Onlus

La Spezia, 19125, Italy

RECRUITING

IRCCS Fondazione Don Carlo Gnocchi Onlus

Milan, 20148, Italy

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Maurizio Ferrarin, PhD, Eng

  IRCCS Fondazione Don Carlo Gnocchi ONLUS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Viganò, MD, PhD

CONTACT

00390240308890; avigano@dongnocchi.it

Gaia Bailo, Eng

CONTACT

00390240308234; gbailo@dongnocchi.it

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: January 29, 2025
• First Posted: April 15, 2025
• Study Start: March 3, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after publication with no end date
• Access Criteria: Request should be addressed to the principal investigator or the corresponding author of the publication.

Locations

IT (3)