Functional Electrical Stimulation on Tibial Nerve in Stroke Patients.

University of Gran Rosario

Status: Enrolling

Conditions: Chronic Stroke

Treatments: Other: FES program

Study type: Interventional

Funder types: Other

Identifiers

NCT05240716

FES on TN in stroke

Details and patient eligibility

About

Hemiparetic gait is one of the most common consequences after stroke. This impairment has a detrimental effects on the patients lies, limiting their social participation. Previous studies have shown that there is a direct relationship between triceps surae activation and gait speed in stroke patients, that is, higher triceps surae muscle activation are correspond to greater gait speed. Then, it can be hypothesized that therapies focused in strengthening the triceps surae also improves the patient gait. It has been shown that Functional Electrical Stimulation (FES) can improve triceps surae activation when applied on healthy subjects. However, it has not been yet explored in chronic stroke patients. Therefore, the aim of this study is to assess whether a FES program over tibial nerve contributes to the rehabilitation of the gait in chronic hemiparetic stroke patients. This study present a prospective interventional design, based on non-probabilistic sampling for convenience, and comprising a total of 15 volunteers with ischemic stroke of both genders and aged between 18 and 70 years old. Volunteers will be recruited from hospitals and private rehabilitation centres, and must be currently engaged in a conventional rehabilitation program. The study will consist of twenty-four sessions, with a frequency of three sessions per week.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ranging between 18 to 70 years.
• Subjects with chronic ischemic stroke (more than 12 months of evolution)
• Ability to walk 20 mts. without third-party assistance.
• Hemiparesis with weakness and spasticity in the triceps surae.

Exclusion criteria

• Previous injury on paretic lower limb
• Soft tissue or joint retraction limiting ankle range of motion (ROM)
• Severe peripheral nervous system compromise
• Electronic devices that could be altered by the use of FES (e.g. cardiac pacemaker)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

FES program

Experimental group

Treatment:

Other: FES program