Association Between the tDCS and FDS for Gait Rehabilitation After Stroke

February 10, 2021 updated by: Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Federal University of Health Sciences of Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ShamtDCS+FDS
Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Sham Transcranial direct brain stimulation (tDCS)
Device: Foot Drop Stimulatio - Neuro Orthosis
Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
Experimental: tDCS+FDS
Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Transcranial direct brain stimulation (tDCS)
Device: Foot Drop Stimulatio - Neuro Orthosis
Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
Device: Transcranial direct brain stimulation
Transcranial direct brain stimulation on motor cortex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
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)
The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
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)
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 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.
The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
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).
The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
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).
The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
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.
The outcome will be assessed at baseline and 2 weeks after the intervention.
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.
The outcome will be assessed at baseline and 2 weeks after the intervention.
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.
The outcome will be assessed at baseline and 2 weeks after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Health Science of Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2019

Primary Completion (Actual)

September 20, 2019

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

June 12, 2019

First Submitted That Met QC Criteria

August 31, 2019

First Posted (Actual)

September 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • tDCS_FDS_2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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