Association Between the tDCS and FDS for Gait Rehabilitation After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04077814
• Other study ID #: tDCS_FDS_2018
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2021
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2020
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• Transcranial direct brain stimulation
Transcranial direct brain stimulation on motor cortex

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Kinetic gait anaysis.	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.
Secondary	Postural Control	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.
Secondary	Functional Mobility	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.
Secondary	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.	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	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).	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	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).	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	Serum levels of Brain-derived neurotrophic fator (BDNF).	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.
Secondary	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.	The outcome will be assessed at baseline and 2 weeks after the intervention.
Secondary	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.	The outcome will be assessed at baseline and 2 weeks after the intervention.