Clinical trial NCT04077814: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Cerebrovascular Accident
Cerebrovascular Stroke
Cerebral Stroke
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Kinematic gait anaysis.
timeFrame: 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:
measure: Kinetic gait anaysis.
timeFrame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
measure: Postural Control
timeFrame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
measure: Functional Mobility
timeFrame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
measure: Assessed by means of the Stroke-Specific Quality of Life Questionnaire (SSQOL)
timeFrame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
measure: Muscular tone assessed by the Modified Ashworth Scale
timeFrame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
measure: Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale
timeFrame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
measure: Serum levels of Brain-derived neurotrophic fator (BDNF).
timeFrame: The outcome will be assessed at baseline and 2 weeks after the intervention.
measure: Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3)
timeFrame: The outcome will be assessed at baseline and 2 weeks after the intervention.
measure: Serum levels of insulin-like growth factors 1 (IGF-1)
timeFrame: The outcome will be assessed at baseline and 2 weeks after the intervention.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Aline S Pagnussat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.