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

Not Applicable

Recruiting

• Conditions: Stroke

• Registration Number: NCT06928857
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

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.

Detailed Description

FitFES is a wearable and non-invasive device that provides continuous stimulation set according to the residual myoelectric activity of hemiparetic muscles. Its bioinspired functioning has been implemented to restore the neurophysiological feedback from the muscles to the central nervous system while performing voluntary movements. This study aims to assess the effects of FitFES device on upper limb motor rehabilitation of post-stroke subjects, compared to traditional rehabilitation treatment. 50 post-stroke subjects will be recruited and randomized into an experimental group and a control group.

All participants will follow a 15-session rehabilitation program, and in each session they will execute task-oriented exercises. The experimental group will be assisted by the FitFES device, while the control group will perform the tasks without the device support.

Each subject will be assessed before and at the end of the rehabilitation protocol. Collected data from both groups will then be compared.

Study Timeline

• Study First Submitted: 2025-01-29
• Study Start: 2025-03-03
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 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

Exclusion Criteria

• 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
• Cardiac arrhythmias
• Hemorrhagic disorders (hemophilia)
• Severe forms of diabetes mellitus
• Known allergy to materials making up the device or its applied parts
• Cancer or tumour disease
• Acute arthritis
• Other neurological diseases other than stroke
• Progressive muscular dystrophy
• Abdominal or inguinal hernias
• Undiagnosed back pain
• Diseases of internal organs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)	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.
Fugl-Meyer Upper Extremity scale (FM-UE)	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)	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).
Box and Block test (BBT)	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)	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
EuroQol 5-Dimension 5-level (EQ-5D-5L) Questionnaire	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1), 1-month follow-up (T2)	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.

Secondary Outcome Measures

Name	Time	Method
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)	Surface Electromyography (EMGs) is a non-invasive tool able to assess muscular electrical activity during the execution of active movements using electrodes applied on the skin surface. Muscular contraction amplitude will be recorded from 24 sensors placed on upper limbs (12 sensors/limb), during the execution of motor acts. Then, the difference between patient's and observed model's temporal dynamic of muscular contraction will be chosen as EMG outcome.
Body Kinematics	Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after T0 (T1)	Kinematics of the upper limb and trunk will be recorded using a 9-camera optoelectronic system during 3D motor acts. The system will measure the 3D coordinates of spherical markers attached to body landmarks to compute trunk, shoulder, elbow and wrist angles.; Data processing will provide measures of deviations from physiological movement.
Treatment Safety	After 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)	Data related to the safety of the device will be collected: 1. Number of adverse events; 2. Number of drop-out related to patient intolerance to the device
Cost-effectiveness ratio	At the end of 15 rehabilitation sessions (each session is 60 minutes) from 3 to 5 weeks after baseline (T1)	The costs of the two rehabilitation paths (with and without device), related to direct costs (maintenance device, consumables) and indirect costs will be collected (training of therapists on the device, costs related to the patient using the device). Procedures to be performed in a single treatment session will also be evaluated, in terms of time needed for preparation and dressing, and of trained personnel required during a session. An estimate of the working cycles that the device can perform in a year will also be considered.

Trial Locations

Locations (3)

Ospedale Policlinico San Martino; 🇮🇹 Genova, Italy

Fondazione Don Carlo Gnocchi Onlus; 🇮🇹 La Spezia, Italy

IRCCS Fondazione Don Carlo Gnocchi Onlus; 🇮🇹 Milano, Italy