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Impact of low electrical stimulation on the scalp and physical training on the adaptations of the system that regulates body functions in patients with weakness on one side of the body resulting from a stroke.

Impact of Transcranial Direct Current Stimulation and physical training on the autonomic adaptations in hemiparetic patients due to the Stroke: Clinical Trial, Controlled, Randomized, Double-blinded

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9gnkr2
Enrollment
Unknown
Registered
2019-06-04
Start date
2019-03-08
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paresis

Interventions

Experimental group: 30 adult hemiparetic patients due to chronic cerebral vascular accident will receive an aerobic physical training in the bicycle together with the transcranial stimulation by conti
Device
Other
E02.331.750
G11.427.410.698.277

Sponsors

UNINOVE
Lead Sponsor

Eligibility

Age
21 Years to 74 Years

Inclusion criteria

Inclusion criteria: To present hemiparesis due to stroke for more than 6 months; Mild or moderate motor impairment determined by the Fugl-Meyer test with lower limb scores between 20 and 31 points; Comfortable walking speed in the ground between 0.3 and 1.15 m / s; Classification between levels 04 to 06 in Functional Mobility Scale (FMS) - Functional Mobility Scale and ability to perform exercise on the bicycle; Presentation of AVC provings; Signature of science regarding the term of free and informed consent (TCLE); Blood test (hematological and biochemical); Image examination of lesion location; The use of beta blockers will not be considered an exclusion factor due to the large percentage of patients taking this drug, a separate analysis will be performed to see if there are baseline differences in the other patients.

Exclusion criteria

Exclusion criteria: To present cognitive deficits in the Mini Mental State Examination (MMSE) with scores below 17 points; Visual impairment that may interfere with the performance of the tests; Severe cardiac problems (congestive heart failure, angina, peripheral vascular disease), use of pacemaker; Contraindications to the use of CTEE (brain implant of metal clips near the area to be stimulated, history of recurrent seizure, recurrent epilepsy and brain tumors, cerebral pacemaker, bore or cracks in the cranial cavity, cutaneous lesions near the area to be stimulated and / or metal plates or devices at the ETCC stimulation site); Irregular menstrual cycle or being in the menstrual period during the evaluation; No medical certificate for the aerobic exercise test

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of physical training and transcranial direct current stimulation on the analysis of heart rate variability in adult hemiparetic patients due to stroke—

Secondary

MeasureTime frame
To evaluate the distance traveled in the vertical ergometric bicycle ;Verify and the time of permanence in the vertical ergometric bicycle;Evaluate Quality of Life;Evaluate Cognition;Evaluate Depression;Evaluate the Mental Stress Test;Check the indexes of dyspnea and fatigue—

Countries

Brazil

Contacts

Public ContactFernanda;Glauber Côrrea;Heinz

UNINOVE;UNINOVE

fecorrea@uninove.br;glauber.heinz@hotmail.com11973440380;+55-011-970883072

Outcome results

None listed

Source: REBEC (via WHO ICTRP)