NCT04077814

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 4, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

September 20, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 11, 2021

Status Verified

February 1, 2021

Enrollment Period

Same day

First QC Date

June 12, 2019

Last Update Submit

February 10, 2021

Conditions

Stroke

Keywords

Cerebrovascular AccidentCerebrovascular StrokeCerebral Stroke

Outcome Measures

Primary Outcomes (1)

  • Kinematic gait anaysis.

    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 Outcomes (9)

  • Kinetic gait anaysis.

    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

    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

    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)

    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

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

  • +4 more secondary outcomes

Study Arms (2)

ShamtDCS+FDS

ACTIVE COMPARATOR

Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Sham Transcranial direct brain stimulation (tDCS)

Device: Foot Drop Stimulatio - Neuro Orthosis

tDCS+FDS

EXPERIMENTAL

Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Transcranial direct brain stimulation (tDCS)

Device: Foot Drop Stimulatio - Neuro OrthosisDevice: Transcranial direct brain stimulation

Interventions

Foot Drop Stimulatio - Neuro OrthosisDEVICE

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

ShamtDCS+FDStDCS+FDS
Transcranial direct brain stimulationDEVICE

Transcranial direct brain stimulation on motor cortex

tDCS+FDS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

  • da Cunha MJ, Pinto C, Schifino GP, Sant'Anna Py I, Cimolin V, Pagnussat AS. Bicephalic Transcranial Direct-Current Stimulation Does Not Add Benefits to a Footdrop Stimulator for Improving Functional Mobility in People With Chronic Hemiparesis After Stroke: A Double-Blind, Randomized Controlled Trial. Phys Ther. 2022 Aug 4;102(8):pzac079. doi: 10.1093/ptj/pzac079.

    PMID: 35689805DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aline S Pagnussat, PhD

    Federal University of Health Sciences of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2019

First Posted

September 4, 2019

Study Start

September 20, 2019

Primary Completion

September 20, 2019

Study Completion

September 30, 2020

Last Updated

February 11, 2021

Record last verified: 2021-02

Locations

BR(1)