Functional Electrical Stimulation on Tibial Nerve in Stroke Patients.

NCT ID: NCT05240716

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Chronic Stroke

Keywords

Functional electrical stimulation; Tibial Nerve stimulation; Chronic stroke; Hemiparetic gait

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FES program

Group Type: EXPERIMENTAL

FES program

Intervention Type: OTHER

8 weeks intervention. 3 sessions per week. Previous to the intervention, volunteers will familiarize with the electrical stimulation by receiving three trials of the stimuli. Electrical current intensity will be set for each volunteers, with the capacity of generating a muscle contraction without inducing discomfort in the volunteer. During the FES program, patient in standing position will perform a step, while electrical current stimulation will be applied to the skin over the tibial nerve on the contralateral of the stimulation side. The FES will be delivered during the paretic plantarflexor activation according to the gait cycle. The FES session will consist of 5-minutes stimulation blocks with breaks between blocks (total session time: 30 minutes). For safety reasons, a physical therapist will supervise all the FES intervention sessions.

Interventions

FES program

8 weeks intervention. 3 sessions per week. Previous to the intervention, volunteers will familiarize with the electrical stimulation by receiving three trials of the stimuli. Electrical current intensity will be set for each volunteers, with the capacity of generating a muscle contraction without inducing discomfort in the volunteer. During the FES program, patient in standing position will perform a step, while electrical current stimulation will be applied to the skin over the tibial nerve on the contralateral of the stimulation side. The FES will be delivered during the paretic plantarflexor activation according to the gait cycle. The FES session will consist of 5-minutes stimulation blocks with breaks between blocks (total session time: 30 minutes). For safety reasons, a physical therapist will supervise all the FES intervention sessions.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Gran Rosario

OTHER

Sponsor Role: lead

Responsible Party

Melisa Taborda

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonardo Intelangelo, MSc

Role: STUDY_DIRECTOR

Universidad del Gran Rosario

Locations

Department of Physical Therapy, Neurofunctional Research Unit - UIN, University Center for Assistance, Teaching and Research - CUADI University of Gran Rosario

Rosario, Santa Fe Province, Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Melisa Taborda, MSc

Role: CONTACT

Phone: 2477663051

Email: mtaborda@ugr.edu.ar

Leonardo Intelangelo, MSc

Role: CONTACT

Phone: 3414450222

Email: lintelangelo@ugr.edu.ar

Facility Contacts

Melisa Taborda, MSc

Role: primary

Leonardo Intelangelo, MSc

Role: backup

Other Identifiers

FES on TN in stroke

Identifier Type: -

Identifier Source: org_study_id