Effects of Transcranial Direct Current Stimulation With Proprioceptive Training in Blind People
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03173105|
Recruitment Status : Not yet recruiting
First Posted : June 1, 2017
Last Update Posted : May 4, 2018
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.
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 - Analyze the effect of anodal tDCS over three areas of the brain (primary motor cortex, somatosensory cortex and visual cortex) on postural control and gait; 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 muscles 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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.|
|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|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||July 30, 2020|
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
- 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
- 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
- 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
- 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
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
|Contact: Claudia S Oliveira, PhD||+55 11 firstname.lastname@example.org|
|Contact: Rodolfo B Parreira, MSc||+55 43 email@example.com|
|University Nove de Julho||Not yet recruiting|
|Sao Paulo, Brazil, 01156-050|
|Contact: Claudia S Oliveira, PhD + 55 11 39681681 firstname.lastname@example.org|
|Contact: Rodolfo B Parreira, MSc +55 43 33754712 email@example.com|
|Principal Investigator: Rodolfo B Parreira, MSc|
|Principal Investigator:||Rodolfo B Parreira, MSc||Salgado Institute of Integral Health|