Functional Electrical Stimulation on Tibial Nerve in Stroke Patients.

NCT05240716 | Recruiting

• 1 other identifier: FES on TN in stroke
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in gait velocity

  A 10 metres walk test will be performed to asses gait velocity.

  Baseline and week 8 (after 24 sessions of intervention)

Secondary Outcomes (12)

• Change in maximal isometric strength

  Baseline, immediately after first session and week 8 (after 24 sessions of intervention)

• Change in Spasticity

  Baseline, immediately after first session and week 8 (after 24 sessions of intervention)

• Change in muscle activity

  Baseline, immediately after first session and week 8 (after 24 sessions of intervention)

• Change in cortical electrical activity

  Baseline and week 8 (after 24 sessions of intervention)

• Changes in cadence

  Baseline and week 8 (after 24 sessions of intervention)

Study Arms (1)

FES program

EXPERIMENTAL

Other: FES program

Interventions

FES program 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.

FES program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Gran Rosario: lead

Study Sites (1)

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

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Study Officials

• Leonardo Intelangelo, MSc

  Universidad del Gran Rosario

  STUDY DIRECTOR

Central Study Contacts

Melisa Taborda, MSc

CONTACT

2477663051; mtaborda@ugr.edu.ar

Leonardo Intelangelo, MSc

CONTACT

3414450222; lintelangelo@ugr.edu.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 15, 2022
• Study Start: March 21, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

AR (1)