tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia
- Conditions
- Ataxia, Cerebellar
- Interventions
- Device: Cerebellar transcranial direct current stimulationOther: Treadmill locomotor trainingDevice: Cerebello-spinal direct current stimulationDevice: Sham Cerebellar transcranial direct current stimulationDevice: Sham cerebello-spinal direct current stimulation
- Registration Number
- NCT03703830
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental I Treadmill locomotor training Cerebellar transcranial current stimulation associated with locomotor training Experimental II Cerebello-spinal direct current stimulation Cerebello-spinal direct current stimulation associated with locomotor training Experimental I Cerebellar transcranial direct current stimulation Cerebellar transcranial current stimulation associated with locomotor training Sham comparator I Treadmill locomotor training Cerebellar transcranial current stimulation sham associated with locomotor training Sham comparator I Sham Cerebellar transcranial direct current stimulation Cerebellar transcranial current stimulation sham associated with locomotor training Experimental II Treadmill locomotor training Cerebello-spinal direct current stimulation associated with locomotor training Sham comparator II Treadmill locomotor training Cerebello-spinal direct current stimulation sham associated with locomotor training Sham comparator II Sham cerebello-spinal direct current stimulation Cerebello-spinal direct current stimulation sham associated with locomotor training
- Primary Outcome Measures
Name Time Method Change in Functional mobility 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 Outcome Measures
Name Time Method Change in Balance Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day. The balance of individuals will be assessed through the Balance Evaluation System Test (BESt), which comprises 14 items with a score of 0-2 each from 0 (worst) to 2 (best performance), used to assess dysfunction in balance and independence in life activities daily.
Change in Ataxia severity Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day. The ataxia' severity will be assessed by the Scale for the Assessment and Rating of Ataxia (SARA). It consists of eight items (gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating, hand movements, and heel-shin slide), where ranges from 0 to 40. Higher score mean more severe ataxia.
Change in Patient global impression Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day The patient's global impression is a questionnaire which the patient has to answer how the treatment changed his life daily activities. Patient will choose the best option that reflects their improvement in quality of life, from "no change" to "much better with differences that have made all the difference".
Change in Fall risk 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 time values and step numbers represent a greater risk of falls. Time greater than 10 seconds in the test means greater risk of falling.
Adverse effects of ctDCS 25 minutes after the beginning of stimulation Brunoni's questionnaire will be used to ask the patient about some possible adverse effects related to stimulations. The patient will be asked always at the end of each stimulation (real or sham).
Trial Locations
- Locations (1)
Kátia Monte-Silva
🇧🇷Recife, Pernambuco, Brazil