Association Between the tDCS and FDS for Gait Rehabilitation After Stroke

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT04077814
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-08-31
• Study First Posted: 2019-09-04
• Study Start: 2019-09-20
• Primary Completion: 2019-09-20
• Study Completion: 2020-09-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Kinematic 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.	Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)

Secondary Outcome Measures

Name	Time	Method
Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer 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.	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).
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.	Assessed by force platform (BTS P-6000)
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.	Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
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.	Evaluated by means of the Timed Up \& Go Test (TUG)
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.	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	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).
Serum levels of Brain-derived neurotrophic fator (BDNF).	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.
Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3)	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.
Serum levels of insulin-like growth factors 1 (IGF-1)	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.

Trial Locations

Locations (1)

Federal University of Health Sciences of Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil