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Clinical Trials/NCT03703830
NCT03703830
Active, not recruiting
Not Applicable

Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia

Universidade Federal de Pernambuco1 site in 1 country20 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ataxia, Cerebellar
Sponsor
Universidade Federal de Pernambuco
Enrollment
20
Locations
1
Primary Endpoint
Change in Functional mobility
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
July 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kátia Monte-Silva

Clinical Professor

Universidade Federal de Pernambuco

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

Outcomes

Primary Outcomes

Change in Functional mobility

Time Frame: Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day

The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer times to performe the Timed Up and Go test mean worse functional mobility.

Secondary Outcomes

  • Change in Balance(Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.)
  • Change in Ataxia severity(Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.)
  • Change in Fall risk(Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.)
  • Change in Patient global impression(Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day)
  • Adverse effects of ctDCS(25 minutes after the beginning of stimulation)

Study Sites (1)

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