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

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ClinicalTrials.gov Identifier: NCT03173105
Recruitment Status : Enrolling by invitation
First Posted : June 1, 2017
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Rodolfo Borges Parreira, Salgado Institute of Integral Health

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.


Condition or disease Intervention/treatment Phase
Blindness, Acquired Blindness Congenital Device: active tDCS Device: sham tDCS Other: Dynamic proprioceptive exercises Other: static proprioceptive exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Protocol Study for a Randomized Controlled Trial of the Effects of Transcranial Direct Current Stimulation (tDCS) Associated With Proprioceptive Training in Blind People
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : July 30, 2021

Arm Intervention/treatment
Active Comparator: Group 1 (G1)
active tDCS + dynamic proprioceptive exercises
Device: active tDCS
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.
Other Name: tDCS - transcranial direct current stimulation

Sham Comparator: Group 2 (G2)
sham tDCS + dynamic proprioceptive exercises
Device: sham tDCS
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
Other Name: tDCS - transcranial direct current stimulation

Active Comparator: Group 3 (G3)
active tDCS + static proprioceptive exercises
Other: Dynamic proprioceptive exercises
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.

Sham Comparator: Group 4 (4)
sham tDCS + static proprioceptive exercises
Other: static proprioceptive exercises
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




Primary Outcome Measures :
  1. Postural control before and after the therapeutic proprioceptive exercises on both static and dynamic postural control in individuals with blindnes [ Time Frame: The entire procedure will lasting about 10 minutes ]
    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


Secondary Outcome Measures :
  1. Gait analysis with and without the use a guide stick, and when wearing shoes or while barefoot [ Time Frame: For gait analysis comparison will lasting about 30 minutes ]
    Subjects will walk on a track five meters in lengthwhere SMART-D 140® system (BTS Engineering) will be used will be used for the collection of kinetic gait data

  2. Surface electromyography [ Time Frame: will lasting about 30 minutes ]
    The electromyographic analysis of the rectus femoris, tibialis anterior and soleum muscles will be performed with the aid of the eight-channel electromyograph. Measure will be taken during gait with and without the use a guide stick, and when wearing shoes or while barefoot

  3. Evaluation of functional mobility [ Time Frame: The entire procedure will lasting about 5 minutes ]
    Evaluation of functional mobility and dynamic balance will be performed with the Timed Up and Go Test, in which the time (seconds) required to stand up from a standardized chair without armrests, walk three meters, turn around, return to the chair and sit down again is recorded



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173105


Locations
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Brazil
Centro Universitário de Anápolis
Anápolis, Goiás, Brazil, 75083-515
Sponsors and Collaborators
Salgado Institute of Integral Health
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Principal Investigator: Rodolfo B Parreira, MSc Salgado Institute of Integral Health
Publications of Results:
Blomqvist S, Rehn B. Validity and reliability of the dynamic one leg stance (DOLS) in people with vision loss. Advances in Physiotherapy 9(3): 129-135, 2007.

Other Publications:

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Responsible Party: Rodolfo Borges Parreira, Rodolfo Borges Parreira, MSc, Salgado Institute of Integral Health
ClinicalTrials.gov Identifier: NCT03173105    
Other Study ID Numbers: SalgadoIIH
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data of the variables studied such as postural control, kinematic analyzes, electromyography as well as the protocol applied to the subjects, will be available after publication of the results. Researchers may request the data from the subjects through the contact with the main investigator
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rodolfo Borges Parreira, Salgado Institute of Integral Health:
Visually Impaired Persons
Postural Balance
Rehabilitation
Transcranial Direct Current Stimulation
Additional relevant MeSH terms:
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Blindness
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases