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Clinical Trials/NCT06724367
NCT06724367
Not yet recruiting
Not Applicable

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

Universidade Federal de Pernambuco0 sites20 target enrollmentDecember 20, 2024
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Universidade Federal de Pernambuco
Enrollment
20
Primary Endpoint
Timed up and go test
Status
Not yet recruiting
Last Updated
last year

Overview

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.
Registry
clinicaltrials.gov
Start Date
December 20, 2024
End Date
March 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kátia Monte-Silva

Professor

Universidade Federal de Pernambuco

Eligibility Criteria

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

Outcomes

Primary Outcomes

Timed up and go test

Time Frame: From the start of treatment until 30 days after the end of treatment.

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.

Secondary Outcomes

  • 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.)

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