跳至主要内容
临床试验/NCT06967493
NCT06967493招募中不适用

"Amazonian Dance for Parkinson": a Protocol Study for a Randomized Clinical Trial on Motor and Non-motor Symptoms of People With Parkinson's.

Federal University of Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
Cognition

研究概览

简要总结

This randomized controlled trial aims to evaluate the effects of a 12-week Amazonian dance program on cognitive and motor symptoms in people with Parkinson's disease (PD), comparing outcomes between participants in the intervention and those in an alternative control intervention.

详细描述

Experimental Design: Randomized controlled single-blind trial with four parallel groups. Study sites include the Federal University of Rio Grande do Sul (South Region, Brazil) and the Federal University of Pará (North Region, Brazil).

Participants: 80 adults aged 50 to 80 years with a clinical diagnosis of idiopathic Parkinson's disease, in stages I-III of the Hoehn & Yahr Scale, under stable pharmacological treatment for at least one year. Participants will be recruited from community health services, Parkinson's associations, and university-affiliated health units in Northern and Southern Brazil.

Interventions:

Amazonian Dance Groups (North and South): Participants will engage in twice-weekly dance sessions for 12 weeks (24 sessions total), including movement practices inspired by Lundum and Carimbó dances, choreographic improvisation, and activities involving memory, storytelling, balance, and mobility.

Control Groups (North and South): Participants will receive a structured non-dance intervention over the same 12-week period. This control activity will consist sessions related to general well-being, physical activity, and quality of life, without dance training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Confirmed diagnosis of PD according to the London Brain Bank Criteria;
  • •Able to understand the verbal instructions for the tests;
  • •Hoehn and Yahr (H&Y) stages I-III
  • •≥ 1 year undergoing medical treatment for PD with regular use of anti-parkinsonian drugs
  • •Capability to participate will be based on the Unified Parkinson's Disease Rating Scale -motor examination

排除标准

  • •Recent surgeries,
  • •Deep brain stimulation (DBS);
  • •Other associated neurological diseases or chronic diseases
  • •Fitted with a pacemaker;
  • •Prostheses in the lower limbs;

研究组 & 干预措施

Dance

Experimental

Dance intervention for 3 months, 2 times/week, 2 hours per week. Dance is a safe and effective form of activity, which has been used in PD population. Participants take part in a dance class specifically for people with PD lead by a qualified dance instructor. The dance class typically include a warm-up, dance related activities developed based on folk and popular dances from the Amazon region in the Brazilian North region and a cool-down.

干预措施: Amazonian Dance (Behavioral)

Control Group

Active Comparator

Nordic Walking was chosen for the active control group because it is a well accepted, low-cost, safe and effective rehabilitation strategy for PwPD (SALSE-BETÁN et al, 2022).

干预措施: Nordic Walking (Behavioral)

结局指标

主要结局

Cognition

时间窗: Change from baseline at 3 months

Cognition will be assessed in two ways using traditional pen-and-paper tests and incorporating innovative instruments and using digital technology. Executive function and attention will be measured using the Tablet-based Cognitive Assessment (Tab-CAT) application, developed for the efficient detection of mild neurocognitive disorders, which assesses cognitive abilities including memory, executive/speed, visuospatial and language (Possin et al., 2018). In this battery, the Dot-counting, Set-shifting, Flanker, and Animal Fluency tests will be used. The Montreal Cognitive Assessment (MoCA) Brazilian version (Hobson, 2015) will be used to screen for mild cognitive impairment, accessing different cognitive domains in the following areas: attention and concentration, executive functions, memory, language, visuoconstructive skills, conceptualization, calculation and guidance. The total MoCA score is 30 points, with a score of 26 or more considered normal.

1.1 - Cognition - Dot-couting

时间窗: Change from baseline at 3 months

This task assesses sustained attention and working memory. The participant is presented with various screens containing different sets of shapes and is instructed to count a specific type. In addition to counting, the participant must remember the totals across multiple trials, which requires continuous focus and short-term retention. This task is sensitive to impairments in attentional and memory systems, often affected in neurological conditions.

1.2 - Cognition - Set-shifting

时间窗: Change from baseline at 3 months

This task aims to assess executive shifting, one of the cognitive functions involved in mental flexibility. The stimuli consist of geometric shapes (rectangle or triangle) in different colors (red or blue). During the test, the participant sees a cue word displayed in the center of the screen-either "color" or "shape". Above this cue, a target stimulus (a colored shape) appears. In the lower left and right corners of the screen, two response options are shown, each representing a different combination of shape and color. The participant must select the correct option based on the instruction word shown-i.e., they must match the target either by color or by shape, alternating between these classification rules depending on the cue presented on each trial.

1.3 - Cognition - Flanker

时间窗: Change from baseline at 3 months

The Flanker Task is used to assess selective attention and inhibitory control. The participant sees a row of five arrows and must quickly indicate the direction of the central arrow (the target), while ignoring the surrounding arrows (flankers). These flankers may be congruent (pointing in the same direction) or incongruent (pointing in the opposite direction). The task measures the individual's ability to suppress irrelevant stimuli and respond accurately to the target, making it a valuable tool for detecting deficits in executive control.

1.4 - Cognition - Animal Fluency

时间窗: Change from baseline at 3 months

In this task, the participant is asked to name as many animals as possible in one minute. It evaluates semantic verbal fluency and is highly sensitive to early dysfunction in brain regions associated with language, particularly in the frontotemporal areas.

1.5 - Cognition - MoCA

时间窗: Change from baseline at 3 months

The MoCA (Montreal Cognitive Assessment) was used to assess global cognition. In Brazil, the interpretation of MoCA scores varies according to educational level and group differences (Cesar et al., 2019). The MoCA cutoff score to differentiate cognitively unimpaired (CU) from people with dementia is 15. To distinguish cognitively unimpaired (CU) from people mild cognitive impairment (MCI), the cutoff score is 19. Furthermore, the MoCA cutoff score for identifying MCI varies according to individuals' educational levels, reflecting the importance of tailoring assessments to educational contexts. For individuals with no formal education, the cutoff score is 11.5. Those with 1 to 4 years of education have a cutoff score of 18. Individuals with 5 to 8 years of education have a cutoff score of 19.5, as do those with 9 to 11 years of schooling. Finally, for individuals with 12 or more years of education, the cutoff score is 22. These values underscore the need to consider educational context

Language

时间窗: Change from baseline at 3 months

The Toolkit to Examine Lifelike Language (TELL) will be used in this study to assess elements of language and speech. This application enables the recording, storage, and encryption of participants' oral productions. Speech samples will be recorded in Wave format (.wav) with an optimal sampling rate of 44.1 kHz and bit depth of 24 bits. Transcriptions will be performed automatically via Whisper, integrated within the TELL platform, and manually reviewed according to standard criteria established in previous studies (Steeb et al., 2018). Both audio files and transcriptions will undergo pre-processing using validated pipelines, allowing for the extraction of linguistic and acoustic features. These automated methods will be employed to identify distinct speech patterns, as described by Garcia et al. (2022). In addition, the tools used in the study offer potential to assess and monitor disease progression and treatment effectiveness in relation to verbal communication (Garcia et al, 2016)

次要结局

  • Anxiety symptoms(Change from baseline at 3 months)
  • Depressive symptoms(Change from baseline at 3 months)
  • Quality of life symptoms(Change from baseline at 3 months)
  • Levels of Hope(Change from baseline at 3 months)
  • Functional Mobility(Change from baseline at 3 months)
  • Fall symptoms(Change from baseline at 3 months)
  • Gait freezing(Change from baseline at 3 months)

研究者

发起方
Federal University of Rio Grande do Sul
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aline Nogueira Haas

Principal Investigator

Federal University of Rio Grande do Sul

研究点 (2)

Loading locations...

相似试验