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

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidade Federal de Pernambuco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transspinal direct current stimulation

    Device

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

  • Sham Comparator

    Device

    transspinal direct current stimulation simulated

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Transspinal direct current stimulationExperimental treatment 1 intervention
Group B: Transspinal direct current stimulation shamSham comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
From the start of treatment until 30 days after the end of treatment.
2

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.

Time frame
From the start of treatment until 30 days after the end of treatment.
3

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.

Time frame
From the start of treatment until 30 days after the end of treatment.
4

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.

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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