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Parkinsons disease is a progressive neurological disorder marked by a decline in the efficacy of dopaminergic synapses in the nigrostriatal pathway, causing motor disturbances. Resting tremor, bradykinesia, and muscle rigidity are the most prominent motor features. These factors result in gait impairments, including slowness and freezing. The primary treatment for the disease is medication. However, while medication does reduce motor symptoms, prolonged usage may lead to an increase of dyskinesias and a worsening of a patients clinical condition. Thus, alternative therapies, such as cerebellospinal direct current stimulation (csDCS), have gained popularity. Studies suggest that csDCS may be an effective approach to mitigate gait disorders in this patient population. Kinesiotherapy is an established therapeutic method that has been demonstrated to promote functional mobility and improve gait. To date, the combination of kinesiotherapy and csDCS has not been tested, thus the purpose of this study is to evaluate the effectiveness of this combined therapy for enhancing functional mobility in Parkinsons disease patients. The goal of this study is to assess the efficacy of blending csDCS and kinesiotherapy for improving patients functional mobility in Parkinsons disease. Two groups of volunteers will be assigned: i) actual csDCS + kinesiotherapy, and ii) sham csDCS + kinesiotherapy. The full procedure involves 10 therapy sessions conducted across two weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| csDCS | Active Comparator |
| |
| csDCS sham | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cerebello-spinal direct current stimulation | Device | Cerebello-spinal direct current stimulation is an electrical stimulus in the cerebellum as well as in the spinal cord that is used to improve functional mobility. To our knowledge, this is the first study to use this setup in individuals with Parkinsons disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Timed Up and Go | For the TUG, the time taken by the patient to perform a task involving standing up from a chair, walking, and sitting back down is measured. The test begins with the patient seated in a chair with their back against the backrest. Upon request, the patient stands up, walks three meters at their fastest yet safe pace, turns around, returns to the chair, and sits down. Shorter times in completing this task indicate better functional mobility. Three repetitions of the test were recorded, and for analysis purposes, the average of the repetitions was used. | From enrollment to the end of treatment at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Five times sit to stand test | For the TSL5, the time taken by the patient to perform the task of sitting and standing from a chair five times consecutively is measured. The test begins with the patient seated in a chair with their back against the backrest. Upon request, the patient stands up and sits down five times at their fastest pace, but safely. Shorter times on this test indicate better functional mobility. The average of three attempts was used as the final result. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kátia Monte-Silva | Contact | 5581986450112 | monte.silvakk@gmail.com | |
| João Fabrício | Contact | 5581986450112 | joaovmelo2015@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kátia Monte-Silva | Universidade Federal de Pernambuco | Study Director |
| João Fabrício | Universidade Federal de Pernambuco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Pernambuco | Recruiting | Recife | Pernambuco | 50740-560 | Brazil |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| sham cerebello-spinal direct current stimulation | Device | Sham cerebello-spinal direct current stimulation involves masking, where the total duration of stimulation is thirty seconds, which is sufficient to mimic the sensation of stimulation but without neuromodulatory effects |
|
| From enrollment to the end of treatment at 4 weeks |
| Mini balance evaluation system test | The abbreviated version of the Balance Evaluation System Test (miniBESTest) assesses static and dynamic balance through six different balance control mechanisms based on 14 specific activities of daily living. Each activity is rated from 0 (worst performance) to 2 (best performance) points. Thus, lower scores indicate poorer balance. | From enrollment to the end of treatment at 4 weeks |
| Unified Parkinson Disease Rating Scale-II and Scale-III | The motor function of the patients was assessed using the Unified Parkinsons Disease Rating Scale (UPDRS). The UPDRS is the most widely used clinical assessment tool for characterizing the motor symptoms of Parkinsons disease and for monitoring the progression of these symptoms and the physical disability caused by the disease. The UPDRS consists of 50 items, each rated from 0 to 4, ranging from the best (0) to the worst motor performance (4), and it is widely accepted for determining the efficacy of interventions in clinical studies. In the present study, Section II was used, which refers to the severity of the disease concerning the performance of activities of daily living. This section includes 13 items, each scored from 0 to 4, from the best to the greatest impairment. Section III of the UPDRS was also used, which corresponds to the motor examination and measures: resting tremor, postural tremor, rigidity, speech, facial expression, chair rise, posture, gait, postural stability | From enrollment to the end of treatment at 4 weeks |
| Freezing of gait questionnaire | The Freezing of Gait Questionnaire (FOG-Q) is a scale that assesses the individual's subjective perception of the severity and impact of freezing on their gait performance. The FOG-Q is classified on a 5-point scale (0 to 4), with a total score ranging from 0 to 24. A higher score indicates that the individual's gait performance is more affected by freezing. | From enrollment to the end of treatment at 4 weeks |
| Six minute walking test | In the 6MWT, the patient walks at their fastest, yet safe, pace along a 30-meter straight path for six minutes. At the end of the test, the total distance covered is calculated. Greater distances indicate better functional mobility. | From enrollment to the end of treatment at 4 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |