Authors
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Universidade Federal do Espírito Santo -More
Category
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Primary study
Registry of Trials»Brazilian Registry of Clinical Trials
Year
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2019
INTERVENTION: 24 individuals will be recruited. The intervention is physical therapy including task‐specific walking training associated with transcranial direct current stimulation (tDCS), 30 min per day, three days per week, over four weeks. A stimulator (DC‐Stimulator Plus, NeuroConn, Ilmenau, Germany) will deliver a continuous direct current by a saline‐soaked pair of surface sponge electrodes (size of electrodes 35cm2). The anode will be placed at the Cz position on the scalp, corressponding to the location of the supplementary motor area, in accordance with the International EEG 10/20 system (Klem et al 1999, Yotnuengnit et al 2018). The cathode will be positioned over the supraorbital area. Participants will receive electrical stimulation of 2 mA, during the walking training. The 30‐min sessions of task‐specific walking training will include practicing part of the task (about 10 min), where the muscles are working in a manner similar to a full task performance and practicing the whole task (about 20 min). The control group will undertake the task‐specific walking training associated with a sham‐ tDCS. The control group will receive the same walking training, electrodes positioning and testing schedule as the experimental group. This will avoid bias related to type and amount of attention given to participants. If the addition of tDCS proves to be effective, the control group may receive the experimental training program after the experiment is complete. The intervention will be undertaken in Clinics of Physiotherapy at the Universidade Federal do EspÃrito Santo. To encourage the participants to comply with the protocol, both groups will be asked to sign a symbolic contract of commitment to the proposed protocol. 12 partcipants will be randomized to the experimetal group and 12 participants to the control group. Gait Other Physical Therapy Modalities Transcutaneous Electric Nerve Stimulation CONDITION: Parkinson Disease Parkinson Disease. ; Parkinson Disease PRIMARY OUTCOME: The primary outcome is comfortable walking speed, measured by the 10‐m Walk Test, and reported in m/s. INCLUSION CRITERIA: Participants will be individuals with Parkinson’s Disease, who will be eligible, if they: are over 40 years of age; are able to walk at least 14 meters, independently, with or without assistive devices; walk at speeds lower than 1.1 m/s; have experienced freezing episodes over the past month, according to the Part I of the New Freezing of Gait Questionnaire (Nieuwboer et al 2009); have adapted to their current anti‐Parkinsonian medication for at least 2 weeks; provide written consent. SECONDARY OUTCOME: Fear of falling will be measured using the Brazilian version of the Falls Efficacy Scale – International (FES‐I Brazil), and reported as scores ranging from 16 to 64, where higher scores indicate greater fear of falling. Freezing of gait will be measured using Parts II and III of the New Freezing of Gait Questionnaire, and reported as scores ranging from 0 to 28, where higher scores indicate worse episodes of freezing. Mobility will be measured by the Timed‐up and Go Test (TUG) and reported as seconds. The number of falls will be recorded by the use of a “falls diaryâ€? , and the proportion of fallers in each group will also be compared. Walking confidence will be measured using the Brazilian version of the modified Gait Efficacy Scale, and reported as scores ranging from 10 to 100. Walking step length and cadence will be measured using the 10‐m Walk Test. Step length will be calculated by dividing the covered distance, i.e., 10m, by the number of steps to cover the distance, and reported in meters. Walking cadence will be calculated by dividing the number of steps by the time to cover the distance, i.e., 10m, and reported in steps/min.
Epistemonikos ID: ea3b2b0883d49dddb5600e84baabea273b7673ca
First added on: Aug 24, 2024