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

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Stroke

Treatments: Other: Usual Care task-oriented upper limb rehabilitation; Device: MeCFES-assisted task-oriented upper limb rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03019744

RISES

Details and patient eligibility

About

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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

MeCFES

Experimental group

Description:

25 daily sessions (45 minutes each) of MeCFES-assisted task-oriented upper limb rehabilitation

Treatment:

Device: MeCFES-assisted task-oriented upper limb rehabilitation

Control

Active Comparator group

Description:

25 daily sessions (45 minutes each) of usual care task-oriented upper limb rehabilitation

Treatment:

Other: Usual Care task-oriented upper limb rehabilitation