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

NCT03173105 | Unknown DMC

• 1 other identifier: SalgadoIIH
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blindness, Acquired; Blindness Congenital

Keywords

Visually Impaired Persons; Postural Balance; Rehabilitation; Transcranial Direct Current Stimulation

Outcome Measures

Primary Outcomes (1)

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

  Two force plates will be used for the collection of kinematic gait data, the recording of displacement of the center of pressure and the determination of contact time between the foot and surface of the force plate

  The entire procedure will lasting about 10 minutes

Secondary Outcomes (3)

• Gait analysis with and without the use a guide stick, and when wearing shoes or while barefoot

  For gait analysis comparison will lasting about 30 minutes

• Surface electromyography

  will lasting about 30 minutes

• Evaluation of functional mobility

  The entire procedure will lasting about 5 minutes

Study Arms (4)

Group 1 (G1)

ACTIVE COMPARATOR

active tDCS + dynamic proprioceptive exercises

Device: active tDCS

Group 2 (G2)

SHAM COMPARATOR

sham tDCS + dynamic proprioceptive exercises

Device: sham tDCS

Group 3 (G3)

ACTIVE COMPARATOR

active tDCS + static proprioceptive exercises

Other: Dynamic proprioceptive exercises

Group 4 (4)

SHAM COMPARATOR

sham tDCS + static proprioceptive exercises

Other: static proprioceptive exercises

Interventions

active tDCS DEVICE

TDCS will be administered using with two sponge (non-metallic) surface electrodes (5 x 7 cm2) moistened with saline solution. For stimulation of the motor motor, somatosensory, and visual cortices with a current of 2mA for 20 minutes. The cathode will be positioned in the medial supraorbital region.

Also known as: tDCS - transcranial direct current stimulation

Group 1 (G1)

sham tDCS DEVICE

Sham TDCS will be administered using with two sponge (non-metallic) surface electrodes (5 x 7 cm2) moistened with saline solution The stimulator will only be switched on for the first 30 seconds, giving the participant the initial sensation of tDCS, but no active stimulation throughout the remainder of the session the proprioceptive exercise session

Also known as: tDCS - transcranial direct current stimulation

Group 2 (G2)

Dynamic proprioceptive exercises OTHER

The dynamic proprioceptive exercises will be conducted as follows: 1) walking slowly then more quickly on a trampoline; 2) walking backward with one foot behind the other; 3) walking forward on a beam; 4) going up and down a flight of stairs; and 5) sitting on a Swiss exercise ball (65 cm) and performing laterolateral, anteroposterior, circling movements and bouncing. Activities will be performed in three one-minute sets.

Group 3 (G3)

static proprioceptive exercises OTHER

The static exercises will be conducted as follows: 1) standing on toes with feet apart; and 2) with feet together; 3) standing on only right leg without support; and 4) on only left leg without support; and 5) standing with heel of right (or left) foot touching toes of left (or right) foot with feet in a straight line over on an unstable surface (wobble board) performed in six sets of 30 seconds each, with a one-minute rest interval between sets

Group 4 (4)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salgado Institute of Integral Health: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (1)

Centro Universitário de Anápolis

Anápolis, Goiás, 75083-515, Brazil

Location

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MeSH Terms

Conditions

Blindness

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Rodolfo B Parreira, MSc

  Salgado Institute of Integral Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The participants won´t know if they will be using the activated tDCS or Sham. The care provider also won´t know whether the participant used the tDCS or Sham as well as the outcome evaluator won´t know which is the patient´s condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rodolfo Borges Parreira, MSc

Model Details: Participants will be randomly allocated to four groups: Group 1 (G1) - active tDCS + dynamic proprioceptive exercises; Group 2 (G2) - sham tDCS + dynamic proprioceptive exercises; Group 3 (G3)- active tDCS + static proprioceptive exercises; and Group 4 (G4) - sham tDCS + static proprioceptive exercises. Randomization will be performed with the use of sealed opaque envelopes containing a card stipulating to which group the volunteer will be allocated (G1, G2, G3 or G4).

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 1, 2017
• Study Start: September 30, 2019
• Primary Completion: May 30, 2021
• Study Completion: July 30, 2021
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: all research data: informed consent, assessments, measures, and results of the given subjects will be made available immediately after publication of the study in a scientific journal
• Access Criteria: Access to all information regarding the data obtained from the participants will be provided via email of the main author.

Locations

BR (1)