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

NCT06724367 | Not Yet Recruiting

• 1 other identifier: 81604324.2.0000.5208
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Functional Ambulation Classification

  From the start of treatment until 30 days after the end of treatment.

• Fugl-Meyer Assessment Scale

  From the start of treatment until 30 days after the end of treatment.

• Mini-Balance Evaluation Systems Test (MiniBESTest)

  From the start of treatment until 30 days after the end of treatment.

• Modified Ashworth scale

  From the start of treatment until 30 days after the end of treatment.

• Patient Global Impression of Change Scale

  Only in the evaluation immediately after treatment.

Study Arms (2)

Transspinal direct current stimulation

EXPERIMENTAL

This group will receive 10 sessions of transspinal direct current stimulation associated with gait training.

Device: Transspinal direct current stimulation

Transspinal direct current stimulation sham

SHAM COMPARATOR

This group will receive 10 sessions of sham transspinal direct current stimulation associated with gait training.

Device: Sham Comparator

Interventions

Transspinal direct current stimulation DEVICE

Direct current electrical stimulation applied non-invasively to the spinal cord.

Transspinal direct current stimulation

Sham Comparator DEVICE

transspinal direct current stimulation simulated

Transspinal direct current stimulation sham

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Kátia Monte-Silva

CONTACT

+55 81 9988631322; monte.silva@ufpe.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 20, 2024
• Primary Completion: December 30, 2025
• Study Completion: March 31, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share