TRANSSPINAL DIRECT CURRENT STIMULATION ON FUNCTIONAL MOBILITY IN POST-STROKE PATIENTS

The aim of this clinical trial is to investigate the effects of transspinal direct current stimulation on the functional mobility of post-stroke patients.

The main question it aims to answer is:

Is transspinal direct current stimulation able to improve functional mobility in post-stroke patients?

The researchers will compare transspinal direct current stimulation associated with gait training with sham transspinal direct current stimulation associated with gait training. To verify the effects of stimulation on the functional mobility of post-stroke patients.

Participants:

• They will be assessed before starting the care, after the care has been completed, 15 and 30 days after the care has been completed.
• They will take part in 10 sessions of transspinal direct current stimulation associated with gait training.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Transspinal direct current stimulation; Device: Sham Comparator

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kátia Monte-Silva; Phone Number: +55 81 9988631322; Email: monte.silva@ufpe.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of ischemic or hemorrhagic stroke, provided by a neurologist.
• Age group greater than or equal to 18 years, of both sexes.
• Any stage of the disease.
• Presence of lower limb sensorimotor disorder related to the stroke
• Absence of cognitive impairment verified through the Mini Mental State Examination (score ≥ 18 for illiterate individuals and ≥ 24 for educated individuals) modified for the Brazilian population.

Exclusion Criteria:

• With other neurological injuries
• With vestibular, visual, cardiovascular or osteomyoarticular disorders of the lower limb that may affect the performance of the proposed tests
• Who have a pacemaker or metallic implants in their spine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transspinal direct current stimulation; This group will receive 10 sessions of transspinal direct current stimulation associated with gait training.	Device: Transspinal direct current stimulation; Direct current electrical stimulation applied non-invasively to the spinal cord.
Sham Comparator: Transspinal direct current stimulation sham; This group will receive 10 sessions of sham transspinal direct current stimulation associated with gait training.	Device: Sham Comparator; transspinal direct current stimulation simulated

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go test	It is an easy-to-use clinical tool that assesses functional mobility. It consists of measuring the time in which an individual is able to get up from a chair, walk for three meters, turn around, go back and sit down again. The test will be carried out three consecutive times, with a 1-minute interval between each attempt, and the value adopted will be the average time (in seconds) taken to carry out the three attempts. It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.	From the start of treatment until 30 days after the end of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Ambulation Classification	The Functional Ambulation Classification (FAC) serves as a parameter for monitoring gait progress during rehabilitation, categorically. It also makes it possible to assess the ability to walk for at least three meters on flat and uneven surfaces, as well as analyzing the ability to walk on ramps and up and down steps. The scale is scored from 1 (non-functional) to 6 (independent on level and uneven surfaces), i.e. the higher the score, the better the outcome. It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.	From the start of treatment until 30 days after the end of treatment.
Fugl-Meyer Assessment Scale	The Fugl-Meyer Assessment Scale is a quantitative instrument used to assess sensorimotor rehabilitation after stroke. Sections E and F, referring to the lower limb, will be used, with a maximum total score of 34 points, and higher scores reflecting better outcomes. It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.	From the start of treatment until 30 days after the end of treatment.
Mini-Balance Evaluation Systems Test (MiniBESTest)	The Mini-Balance Evaluation Systems Test is a validated scale capable of evaluating balance in patients with neurological disorders. It consists of 14 items and higher scores imply better outcomes. It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.	From the start of treatment until 30 days after the end of treatment.
Modified Ashworth scale	The modified Ashworth scale is a 6-point ordinal scale that grades the resistance encountered during passive muscle stretching, with higher values representing worse outcomes. It will be applied to the following joints: hip (flexion, extension, abduction and adduction); knee (flexion and extension) and ankle (plantar flexion and dorsiflexion). It will be measured before starting treatment, immediately afterwards, 15 and 30 days after the end of treatment.	From the start of treatment until 30 days after the end of treatment.
Patient Global Impression of Change Scale	The Patient Global Impression of Change Scale is a scale where individuals rate their improvement related to the intervention they have undergone and its score ranges from 1 (no change) to 7 (much better). It will be applied by a researcher not involved in the study, only at the re-evaluation, as it aims to assess the patient perception of improvement after the intervention.	Only in the evaluation immediately after treatment.

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco

Study record dates

Study Major Dates

• Study Start (Estimated): December 20, 2024
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 81604324.2.0000.5208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No