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NCT Number: NCT06724367

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transspinal direct current stimulation

Device

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

Sham Comparator

Device

transspinal direct current stimulation simulated

Primary outcomes

  1. 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

  1. Functional Ambulation Classification

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

    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.

  2. Fugl-Meyer Assessment Scale

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

    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.

  3. Mini-Balance Evaluation Systems Test (MiniBESTest)

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

    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.

  4. Modified Ashworth scale

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

    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.

  5. Patient Global Impression of Change Scale

    Time frame: Only in the evaluation immediately after treatment.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kátia Monte-Silva

CONTACT

[email protected]

+55 81 9988631322

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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