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Completed

NCT Number: NCT04077814

Association Between the tDCS and FDS for Gait Rehabilitation After Stroke

The aim of this study is to verify the effectiveness of tDCS combined with foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate compromise.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects with ischemic or hemorrhagic stroke diagnosis.
  • Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months)
  • Minimal cognitive ability to understand commands
  • Able to walk 10 meters unassisted or with minimal assistance

Exclusion criteria

  • No current use of antiepileptic drugs for seizures
  • Secondary musculoskeletal disorder involving the lower limb
  • Contraindication for electrical stimulation

Treatment and study plan

Foot Drop Stimulatio - Neuro Orthosis

Device

Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.

Transcranial direct brain stimulation

Device

Transcranial direct brain stimulation on motor cortex

Primary outcomes

  1. Kinematic gait anaysis.

    Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.

    Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)

Secondary outcomes

  1. Kinetic gait anaysis.

    Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.

    Assessed by force platform (BTS P-6000)

  2. Postural Control

    Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.

    Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)

  3. Functional Mobility

    Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.

    Evaluated by means of the Timed Up & Go Test (TUG)

  4. Assessed by means of the Stroke-Specific Quality of Life Questionnaire (SSQOL)

    Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.

    The SSQOL questionnaire assesses the quality of life of stroke subject, and it contains 49 items with 12 domains (energy, family role, language, mobility, mood, personality, self-care, social role, reasoning, upper limb function, vision and work/productivity). There are three possible answers on the 5-point Likert scale.

    The SSOOL questionnaire score reports a minimum of 49 points and a maximum of 245 points. The lower values represent the more dependence and difficulty to perform tasks.

  5. Muscular tone assessed by the Modified Ashworth Scale

    Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.

    Assessed by the Modified Ashworth Scale. This scale consists of 5 ordinal values ranging from 0 (no tonus increase) to 4 (stiffness).

  6. Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale

    Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.

    Fugl-Meyer scale of lower limb impairment. The evaluation includes measurement of voluntary movement, velocity, coordination and reflex activity, through an ordinal scale applied to each item: 0- cannot be performed, 1- partially performed, and 2-performed completely. Participants were also classified according their LL motor impairment in severe (0 to19), moderate (20 to 28) or mild (> 29 points).

  7. Serum levels of Brain-derived neurotrophic fator (BDNF).

    Time frame: The outcome will be assessed at baseline and 2 weeks after the intervention.

    The biomarker BDNF will be determined using the enzyme-linked immunosorbent assay (ELISA) method.

  8. Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3)

    Time frame: The outcome will be assessed at baseline and 2 weeks after the intervention.

    The biomarker IGFBP-3 will be analyzed in the blood sample to evaluate the neuromuscular adaptations indirectly. Serum IGFBP-3 levels will be determined using the enzyme-linked immunosorbent assay (ELISA) method.

  9. Serum levels of insulin-like growth factors 1 (IGF-1)

    Time frame: The outcome will be assessed at baseline and 2 weeks after the intervention.

    The IGF-1 will be analyzed in the blood sample to evaluate the neuromuscular adaptations indirectly. Serum IGF-1 levels will be determined using the enzyme-linked immunosorbent assay (ELISA) method.

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study title

Association Between the Transcranial Direct Current Stimulation (tDCS) and Foot Drop Stimulation (FDS) for Gait Rehabilitation After Stroke - A Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 4, 2019
Registry last updated
Feb 11, 2021

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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