search
Back to results

Association Between the tDCS and FDS for Gait Rehabilitation After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Foot Drop Stimulatio - Neuro Orthosis
Transcranial direct brain stimulation
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Federal University of Health Sciences of Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ShamtDCS+FDS

tDCS+FDS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Kinetic gait anaysis.
Assessed by force platform (BTS P-6000)
Postural Control
Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
Functional Mobility
Evaluated by means of the Timed Up & Go Test (TUG)
Assessed by means of the Stroke-Specific Quality of Life Questionnaire (SSQOL)
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.
Muscular tone assessed by the Modified Ashworth Scale
Assessed by the Modified Ashworth Scale. This scale consists of 5 ordinal values ranging from 0 (no tonus increase) to 4 (stiffness).
Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale
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).
Serum levels of Brain-derived neurotrophic fator (BDNF).
The biomarker BDNF will be determined using the enzyme-linked immunosorbent assay (ELISA) method.
Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3)
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.
Serum levels of insulin-like growth factors 1 (IGF-1)
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.

Full Information

First Posted
June 12, 2019
Last Updated
February 10, 2021
Sponsor
Federal University of Health Science of Porto Alegre
search

1. Study Identification

Unique Protocol Identification Number
NCT04077814
Brief Title
Association Between the tDCS and FDS for Gait Rehabilitation After Stroke
Official Title
Association Between the Transcranial Direct Current Stimulation (tDCS) and Foot Drop Stimulation (FDS) for Gait Rehabilitation After Stroke - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ShamtDCS+FDS
Arm Type
Active Comparator
Arm Description
Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Sham Transcranial direct brain stimulation (tDCS)
Arm Title
tDCS+FDS
Arm Type
Experimental
Arm Description
Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Transcranial direct brain stimulation (tDCS)
Intervention Type
Device
Intervention Name(s)
Foot Drop Stimulatio - Neuro Orthosis
Intervention Description
Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
Intervention Type
Device
Intervention Name(s)
Transcranial direct brain stimulation
Intervention Description
Transcranial direct brain stimulation on motor cortex
Primary Outcome Measure Information:
Title
Kinematic gait anaysis.
Description
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
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.
Secondary Outcome Measure Information:
Title
Kinetic gait anaysis.
Description
Assessed by force platform (BTS P-6000)
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.
Title
Postural Control
Description
Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
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.
Title
Functional Mobility
Description
Evaluated by means of the Timed Up & Go Test (TUG)
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.
Title
Assessed by means of the Stroke-Specific Quality of Life Questionnaire (SSQOL)
Description
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.
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.
Title
Muscular tone assessed by the Modified Ashworth Scale
Description
Assessed by the Modified Ashworth Scale. This scale consists of 5 ordinal values ranging from 0 (no tonus increase) to 4 (stiffness).
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.
Title
Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale
Description
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).
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.
Title
Serum levels of Brain-derived neurotrophic fator (BDNF).
Description
The biomarker BDNF will be determined using the enzyme-linked immunosorbent assay (ELISA) method.
Time Frame
The outcome will be assessed at baseline and 2 weeks after the intervention.
Title
Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3)
Description
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.
Time Frame
The outcome will be assessed at baseline and 2 weeks after the intervention.
Title
Serum levels of insulin-like growth factors 1 (IGF-1)
Description
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.
Time Frame
The outcome will be assessed at baseline and 2 weeks after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aline S Pagnussat, PhD
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
35689805
Citation
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.
Results Reference
derived

Learn more about this trial

Association Between the tDCS and FDS for Gait Rehabilitation After Stroke

We'll reach out to this number within 24 hrs