UnknownNot Applicable

Effects of Transcranial Direct Current Stimulation With Proprioceptive Training in Blind People

Brazil40 participantsStarted 2019-09-30

Plain-language summary

Postural control requires the integration of the vestibular, visual, and somatosensory systems. Vision, in particular, exerts a considerable influence on body sway during activities that require balance. The investigators aimed to analyze the effects of transcranial direct current stimulation (tDCS) combined with proprioceptive exercises on postural control in individuals between 18 and 55 years old, with congenital and acquired blindness. The intervention will occur in three phases: 1 - Determine differences in postural control and gait between individuals with congenital and acquired blindness with and without the use of a guide stick when wearing shoes and when barefoot; 2 - Will be a pilot study containing 10 subjects in each group (total of 40) where a sample size estimation will be analyzed based on a gait and balance parameters result from a ten consecutive days treatment protocol consisting of tDCS plus proprioceptive; 3 - A treatment protocol will be conducted in which the participants will be allocated to four groups: G1 - active tDCS + dynamic proprioceptive exercises; G2 - sham tDCS + dynamic proprioceptive exercises; G3 - active tDCS + static proprioceptive exercises; and G4 - sham tDCS + static proprioceptive exercises. Evaluations will involve a camera system for three-dimensional gait analysis, a force plate to measure the postural control, and electromyography to analyze the muscle activities. Dynamic stability will be determined using the Timed Up and Go test and static stability will be analyzed with the aid of the force plate. The viability of this study will allow the determination of differences in postural control between individuals with congenital and acquired blindness, the analysis of the effect of tDCS on postural control, and the establishment of a rehabilitation protocol.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Abnormalities of the optic nerve * Retina disorders * Glaucoma * Stargardt disease * Macular degeneration * Retinitis pigmentosa * Congenital toxoplasmosis * Congenital cataracts * Congenital Leber's amaurosis * Detached retina * Astrocytoma Exclusion Criteria: * Medical diagnosis of injury affecting balance in the previous three years * Use of medication affecting the central nervous system * Coordination or balance * Current symptoms of vertigo or dizziness * Medical neurological diagnosis or symptoms suggestive of vestibular disorder * Past surgery or clinical condition of lower limbs or spinal column that can affect balance and gait.

Questions worth asking your doctor

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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postural control before and after the therapeutic proprioceptive exercises on both static and dynamic postural control in individuals with blindnes

Timeframe: The entire procedure will lasting about 10 minutes

Trial details

NCT IDNCT03173105

SponsorSalgado Institute of Integral Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05-30

View on ClinicalTrials.gov More Blindness, Acquired trials