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Functional Electrical Stimulation on Tibial Nerve in Stroke Patients.

Primary Purpose

Chronic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
FES program
Sponsored by
University of Gran Rosario
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Functional electrical stimulation, Tibial Nerve stimulation, Chronic stroke, Hemiparetic gait

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FES program

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in maximal isometric strength
To assess maximal isometric strength of dorsiflexor muscles, volunteers will performed 3 maximum repetitions of 6 seconds of isometric dorsiflexion. Force will be quantified using a load cell (maximum tension-compression = 200 Kgf, accuracy 0.1 Kgf, maximum measurement error = 0.33%; Equipo Biomédico Miotec ™, Porto Alegre, RS, Brazil), and this cell will be placed on a rigid surface and strapped to the volunteer's foot. In addition, the recorded force will be synchronised with the electromyograph to evaluate the isometric tensile strength. During this assessment, volunteers will be in supine position with the assessed lower limb extended on the stretcher.
Change in Spasticity
The Modified Ashworth scale will be performed with volunteers in supine position, and the assessed lower limb extended on the stretcher. Passive stretching of the triceps surae will be applied at a constant speed from the position of maximum plantarflexion to the maximum possible dorsiflexion. Scores range from 0 to 4. A score of 0 indicates no resistance, and 4 indicates rigidity.
Change in muscle activity
Surface electromyography (sEMG) will be recorded to assess activation of the tibialis anterior muscle. Four EMG channels will be acquired using commercial device (Miotec Suite ™, Biomedical Equipment, Porto Alegre, RS, Brazil). The electrodes (Ag/AgCl, with a centre-to-centre distance of 2 cm) will be align parallel to the muscle fibres of the tibialis anterior muscle, according to the recommendations of the International Society of Electrophysiology and Kinesiology (ISEK http://www.isek-online.org). A reference electrode will be placed on the lateral malleolus. Prior to electrode placement, the skin will be shaved and cleaned with cotton and 70% alcohol, in order to minimize skin impedance. The electromyographic recordings will be performed in the supine position, with the assessed leg extended and the opposite leg flexed at 70º with plantar support (measured by a goniometer).
Change in cortical electrical activity
Electroencephalography (EEG) will be recorded during active movement of the affected lower limb using a BIOAMP electroencephalography instrument (UNER, Oro Verde, Entre Ríos, Argentina), using a cap with 15 electrodes distributed according to the international 10-20 system. The volunteer will be seated with feet fully supported on a surface. During the recordings, the volunteers will be instructed to achieve relaxation to measure the resting state, and then they will be asked to perform an active movement of the affected lower limb.
Changes in cadence
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Changes in stride length
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Change in stride time
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Change in swing phase
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Change in stance phase
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Change in double support
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Change in stride velocity
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Change in spasticity
Modified Tardieu scale will be performed with volunteers in supine position, and the assessed lower limb extended on the stretcher. Passive stretching of the triceps surae will be applied with faster speed and then with slow speed from the position of maximum plantarflexion to the maximum possible dorsiflexion to determine the values of R1 (the angle of muscle reaction with fast speed stretch) and R2 (degrees of dorsiflexion reached with slow speed stretch).

Full Information

First Posted
January 31, 2022
Last Updated
June 1, 2022
Sponsor
University of Gran Rosario
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1. Study Identification

Unique Protocol Identification Number
NCT05240716
Brief Title
Functional Electrical Stimulation on Tibial Nerve in Stroke Patients.
Official Title
Assessing the Usefulness of Functional Electrical Stimulation Program on Tibial Nerve for Rehabilitation of Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Gran Rosario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
Functional electrical stimulation, Tibial Nerve stimulation, Chronic stroke, Hemiparetic gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FES program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
FES program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in gait velocity
Description
A 10 metres walk test will be performed to asses gait velocity.
Time Frame
Baseline and week 8 (after 24 sessions of intervention)
Secondary Outcome Measure Information:
Title
Change in maximal isometric strength
Description
To assess maximal isometric strength of dorsiflexor muscles, volunteers will performed 3 maximum repetitions of 6 seconds of isometric dorsiflexion. Force will be quantified using a load cell (maximum tension-compression = 200 Kgf, accuracy 0.1 Kgf, maximum measurement error = 0.33%; Equipo Biomédico Miotec ™, Porto Alegre, RS, Brazil), and this cell will be placed on a rigid surface and strapped to the volunteer's foot. In addition, the recorded force will be synchronised with the electromyograph to evaluate the isometric tensile strength. During this assessment, volunteers will be in supine position with the assessed lower limb extended on the stretcher.
Time Frame
Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Title
Change in Spasticity
Description
The Modified Ashworth scale will be performed with volunteers in supine position, and the assessed lower limb extended on the stretcher. Passive stretching of the triceps surae will be applied at a constant speed from the position of maximum plantarflexion to the maximum possible dorsiflexion. Scores range from 0 to 4. A score of 0 indicates no resistance, and 4 indicates rigidity.
Time Frame
Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Title
Change in muscle activity
Description
Surface electromyography (sEMG) will be recorded to assess activation of the tibialis anterior muscle. Four EMG channels will be acquired using commercial device (Miotec Suite ™, Biomedical Equipment, Porto Alegre, RS, Brazil). The electrodes (Ag/AgCl, with a centre-to-centre distance of 2 cm) will be align parallel to the muscle fibres of the tibialis anterior muscle, according to the recommendations of the International Society of Electrophysiology and Kinesiology (ISEK http://www.isek-online.org). A reference electrode will be placed on the lateral malleolus. Prior to electrode placement, the skin will be shaved and cleaned with cotton and 70% alcohol, in order to minimize skin impedance. The electromyographic recordings will be performed in the supine position, with the assessed leg extended and the opposite leg flexed at 70º with plantar support (measured by a goniometer).
Time Frame
Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Title
Change in cortical electrical activity
Description
Electroencephalography (EEG) will be recorded during active movement of the affected lower limb using a BIOAMP electroencephalography instrument (UNER, Oro Verde, Entre Ríos, Argentina), using a cap with 15 electrodes distributed according to the international 10-20 system. The volunteer will be seated with feet fully supported on a surface. During the recordings, the volunteers will be instructed to achieve relaxation to measure the resting state, and then they will be asked to perform an active movement of the affected lower limb.
Time Frame
Baseline and week 8 (after 24 sessions of intervention)
Title
Changes in cadence
Description
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Time Frame
Baseline and week 8 (after 24 sessions of intervention)
Title
Changes in stride length
Description
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Time Frame
Baseline and week 8 (after 24 sessions of intervention)
Title
Change in stride time
Description
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Time Frame
Baseline and week 8 (after 24 sessions of intervention)
Title
Change in swing phase
Description
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Time Frame
Baseline and week 8 (after 24 sessions of intervention)
Title
Change in stance phase
Description
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Time Frame
Baseline and week 8 (after 24 sessions of intervention)
Title
Change in double support
Description
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Time Frame
Baseline and week 8 (after 24 sessions of intervention)
Title
Change in stride velocity
Description
An inertial sensor system (LegSys) will be placed above the malleolus in both lower limbs for assessing gait cadence. The patient will be asked to walk at their normal pace for a 10 (ten) metre length, if necessary with their assistive device.
Time Frame
Baseline and week 8 (after 24 sessions of intervention)
Title
Change in spasticity
Description
Modified Tardieu scale will be performed with volunteers in supine position, and the assessed lower limb extended on the stretcher. Passive stretching of the triceps surae will be applied with faster speed and then with slow speed from the position of maximum plantarflexion to the maximum possible dorsiflexion to determine the values of R1 (the angle of muscle reaction with fast speed stretch) and R2 (degrees of dorsiflexion reached with slow speed stretch).
Time Frame
Baseline, immediately after first session and week 8 (after 24 sessions of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melisa Taborda, MSc
Phone
2477663051
Ext
+54
Email
mtaborda@ugr.edu.ar
First Name & Middle Initial & Last Name or Official Title & Degree
Leonardo Intelangelo, MSc
Phone
3414450222
Ext
+54
Email
lintelangelo@ugr.edu.ar
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Intelangelo, MSc
Organizational Affiliation
Universidad del Gran Rosario
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physical Therapy, Neurofunctional Research Unit - UIN, University Center for Assistance, Teaching and Research - CUADI University of Gran Rosario
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melisa Taborda, MSc
Phone
2477663051
Ext
+54
Email
mtaborda@ugr.edu.ar
First Name & Middle Initial & Last Name & Degree
Leonardo Intelangelo, MSc
Phone
0341-4450222
Ext
+54
Email
lintelangelo@ugr.edu.ar

12. IPD Sharing Statement

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Functional Electrical Stimulation on Tibial Nerve in Stroke Patients.

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