Clinical trial NCT05240716: 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
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: Functional electrical stimulation
Tibial Nerve stimulation
Chronic stroke
Hemiparetic gait
Lead sponsor: University of Gran Rosario
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in gait velocity
timeFrame: Baseline and week 8 (after 24 sessions of intervention)
Secondary outcomes:
measure: Change in maximal isometric strength
timeFrame: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
measure: Change in Spasticity
timeFrame: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
measure: Change in muscle activity
timeFrame: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
measure: Change in cortical electrical activity
timeFrame: Baseline and week 8 (after 24 sessions of intervention)
measure: Changes in cadence
timeFrame: Baseline and week 8 (after 24 sessions of intervention)
measure: Changes in stride length
timeFrame: Baseline and week 8 (after 24 sessions of intervention)
measure: Change in stride time
timeFrame: Baseline and week 8 (after 24 sessions of intervention)
measure: Change in swing phase
timeFrame: Baseline and week 8 (after 24 sessions of intervention)
measure: Change in stance phase
timeFrame: Baseline and week 8 (after 24 sessions of intervention)
measure: Change in double support
timeFrame: Baseline and week 8 (after 24 sessions of intervention)
measure: Change in stride velocity
timeFrame: Baseline and week 8 (after 24 sessions of intervention)
measure: Change in spasticity
timeFrame: Baseline, immediately after first session and week 8 (after 24 sessions of intervention)
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Department of Physical Therapy, Neurofunctional Research Unit - UIN, University Center for Assistance, Teaching and Research - CUADI University of Gran Rosario
state: Santa Fe
Study officials:
affiliation: Universidad del Gran Rosario
name: Leonardo Intelangelo, MSc
role: STUDY_DIRECTOR
References: