Postural Balance Clinical Trial
Official title:
Trans-spinal Electrical Stimulation in Individuals With Spinocerebellar Ataxia: a Pragmatic Study
Verified date | February 2024 |
Source | Centro Universitário Augusto Motta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main goal of this pragmatic clinical trial is to investigate the effects of trans-spinal tDCS in individuals with spinocerebellar ataxia (SCA) over some parameters of gait and postural control in real-world conditions, reflecting daily clinical practice. The main questions it aims to answer are: - If an extended number of tDCS sessions, beyond the typical 5 to 10 sessions described in scientific literature, applied concomitantly with exercises with progressive challenges, to yield positive outcomes over some parameters of gait and postural control in individuals with SCA and if there is retention of possible benefits one month later the end of this protocol. - If there is specific characteristics (including balance, gait, mobility, severity of ataxia, DNA test characteristics and non-ataxic signs) in individuals with SCA that can predict their improvement in postural control and gait following the 20 tDCS sessions. - Participants will receive 20 tDCS sessions concomitantly with exercises for gait and postural control with progressive challenges. - Postural control and gait of the participants will be assessed in two big sessions before (#assessment 1) and after the 20 sessions (#assessment 5) and 3 small sessions after every 5 sessions (#assessments 2, 3 and 4). Also, as a follow-up, they will be assessed a month after the end of the intervention (#assessment 6).
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | July 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Individuals aged 18 to 70, without distinction of gender or ethnicity; 2. Diagnosed with spinocerebellar ataxia, of any type, by a neurologist; 3. With mild to moderate ataxia severity; 4. Able to walk 2 meters even when using a walker, cane or crutch; 5. Score =21 (BERTOLUCCI et al., 1994) on the Mini-Mental State Examination (MMSE; FOLSTEINet al., 1975; ALMEIDA, 1998); 6. No other concomitant neurological changes. Exclusion Criteria: 1. Illiterate; 2. Being subjected to any other experimental physiotherapeutic or medicinal intervention during the clinical trial; 3. Skin condition that may affect the electrode placement site 4. Musculoskeletal, neurological or cardiorespiratory disorders that prevent the tests from being carried out; 5. Epilepsy; 6. Pregnancy; 7. History of brain surgery; 8. History of seizures; 9. Metallic implants in the skull that interfere with neuromodulation; |
Country | Name | City | State |
---|---|---|---|
Brazil | Anna Fontes Baptista | Rio de Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Laura Alice Santos Oliveira | Federal Institute of Rio de Janeiro |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postural control | The Berg Balance Scale (BBS) measures functional balance and fall risk in 14 tasks. Each item is given a score of 0-4, with a total score between 0 and 56, being the higher the score, the better the individual's performance. The Berg scale also predicts the risk of falls. A score equal to or less than 45 points indicates a greater risk of falls. The four-stage test (4-stage) assesses static balance and measures an individual's ability to hold a series of four balance positions, each more challenging than the previous, for at least 10 seconds each. |
Baseline, after 20 sessions and follow up (one month) | |
Primary | Mobility | Timed up and go (TUG) assesses mobility, balance, walking ability and the risk of falling. On the command "go", the patient gets up from the chair, walks 3 meters, turns around, returns to the chair, and sits down. The time is calculated in seconds. The longer the time taken, the greater the risk of falling | Baseline, at the end of sessions 5, 10, 15 and 20 (each session is 1 day), and follow up (one month) | |
Primary | Gait performance | Measured by the Modified Dynamic Gait Index (mDGI) which total score is from 0 (severe gait impairment) to 64 (no gait impairment) and a Ten-meter walk test with an accelerometer fixed at the sacrum to assess step and stride time, speed, and gait cadence. | Baseline, at the end of sessions 5, 10, 15 and 20 (each session is 1 day) and and follow up (one month) | |
Secondary | The subjective experience of the participants regarding the protocol. | Semi-structured interview regarding subjective experience of the participants relative to the study intervention | At the end of session 20 (each session is 1 day) |
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