tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia
Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia
| Sponsors |
Lead Sponsor: Universidade Federal de Pernambuco |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Source | Universidade Federal de Pernambuco | ||||||||||||
| Brief Summary | Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Pharmacological interventions are not able to modify ataxia gait pattern, therefore, new approaches to rehabilitate must be studied. Treadmill locomotor training (TLT) and cerebellar transcranial direct current stimulation (ctDCS) are physical therapy techniques able to module cerebellar afferences and modify positively ataxia gait pattern. However, there is no study involving the association of these two techniques. The purpose of this study is to evaluate the effects of ctDCS associated to TLT on functional mobility in subjects with cerebellar ataxia. A randomized, sham controlled, double blind clinical trial will be performed. The subjects will be randomly allocated into two groups: (i) ctDCS associated with TLT; (ii) ctDCS sham associated with TLT. The TLT will be performed with a speed and step length progression protocol for 25 minutes. The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during TLT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance and fall risky, will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA), balance evaluation system test (miniBest) and TUG, respectively. |
||||||||||||
| Overall Status | Recruiting | ||||||||||||
| Start Date | November 1, 2018 | ||||||||||||
| Completion Date | February 28, 2020 | ||||||||||||
| Primary Completion Date | January 31, 2020 | ||||||||||||
| Phase | N/A | ||||||||||||
| Study Type | Interventional | ||||||||||||
| Primary Outcome |
|
||||||||||||
| Secondary Outcome |
|
||||||||||||
| Enrollment | 20 | ||||||||||||
| Condition | |||||||||||||
| Intervention |
Intervention Type: Device Intervention Name: Cerebellar transcranial direct current stimulation Description: Cerebellar transcranial direct current stimulation (ctDCS) will be applied during 25 minutes at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. Arm Group Label: Experimental Intervention Type: Other Intervention Name: Treadmill locomotor training Description: The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS Intervention Type: Device Intervention Name: Sham Cerebellar transcranial direct current stimulation Description: Sham Cerebellar transcranial direct current stimulation (ctDCS sham) will be applied during 30 seconds at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking. Arm Group Label: Sham comparator |
||||||||||||
| Eligibility |
Criteria:
Inclusion Criteria: - Cerebellar ataxia - Ages: 18 to 65 years; - Gender: Both; - Score ≥ 3 and < 8 in subscore of gait in the Scale for the Assessment and Rating of Ataxia Exclusion Criteria: - Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests; - Pacemaker; - History of seizures; - Metallic implants in the head or neck; - Medication change during the period of study Gender: All Minimum Age: 18 Years Maximum Age: 65 Years Healthy Volunteers: No |
||||||||||||
| Overall Contact |
Last Name: Kátia Monte-Silva, PhD Phone: +55 81 9988631322 Email: [email protected] |
||||||||||||
| Location |
|
||||||||||||
| Location Countries |
Brazil |
||||||||||||
| Verification Date |
July 2019 |
||||||||||||
| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Universidade Federal de Pernambuco Investigator Full Name: Kátia Monte-Silva Investigator Title: Clinical Professor |
||||||||||||
| Keywords | |||||||||||||
| Has Expanded Access | No | ||||||||||||
| Condition Browse | |||||||||||||
| Number Of Arms | 2 | ||||||||||||
| Arm Group |
Label: Experimental Type: Experimental Description: Cerebellar transcranial current stimulation associated with locomotor training Label: Sham comparator Type: Sham Comparator Description: Cerebellar transcranial current stimulation sham associated with locomotor training |
||||||||||||
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
||||||||||||