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临床试验/NCT06963918
NCT06963918尚未招募不适用

Effect of Expiratory Muscle Strength Training on Forward Trunk Flexion in Parkinson's Disease

General University Hospital, Prague1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Change in the forward trunk flexion (FTF) angle

研究概览

简要总结

Postural abnormalities involving the trunk are prevalent in over 20% of patients with Parkinson's disease (PD). Pathological forward trunk flexion (FTF) is a drug-refractory complication in patients with PD leading to imbalance, pain and fall-related injuries. Deep abdominal muscle training is a key rehabilitation strategy for FTF, as muscles like the transversus abdominis and multifidus are crucial for lumbar stabilization. This training has been shown to improve body position and lumbar proprioception.

Abdominal muscles are also responsible for forced expiration. Expiratory muscle strength training (EMST) utilizing forced expiration through expiratory trainer has emerged as a beneficial intervention in the non-pharmacological management of PD, positively impacting clinical aspects such as dysphagia, dystussia, hypokinetic dysarthria, and drooling. EMG study showed large abdominal muscles activity, particularly the transversus abdominis and internus obliquus abdominis during EMST. Therefore, EMST might also be effective in improving lumbar stabilization.

Given the established role of abdominal muscles in trunk stabilization, it is plausible that activation of deep abdominal muscles during EMST with the right level of resistance might improve FTF in PD patients. No studies have yet examined the effect of EMST on posture in PD.

The primary aim of this study will be to evaluate the effect of EMST on forward trunk flexion in patients with Parkinson's disease.

The secondary aim will be to assess the potential duration of the EMST effect on postural abnormalities and its impact on patient stability.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Parkinson's Disease
  • Age ≥ 18 years
  • MoCA (Montreal Cognitive Assessment) score ≥19
  • Pathological forward trunk flexion defined as thoracic (≥25°) or lumbar (>15°) flexion during standing and walking, which completely disappears in the supine position.

排除标准

  • Severe dyskinesia or "on-off" fluctuations
  • Change in the PD medication in the last 3 months prior to enrollment
  • History of major spinal surgery or musculoskeletal spinal disorders
  • Need for assistive devices when rising from a chair or bed
  • Other neurological, orthopedic, or cardiovascular comorbidities that could affect postural control
  • Inadequate lip seal.

结局指标

主要结局

Change in the forward trunk flexion (FTF) angle

时间窗: Week 0, Week 8, Week 12

Forward trunk flexion will be assessed using standardized postural photographs. Images will be taken with a camera mounted on a tripod positioned 1 meter above the ground and 3 meters from the participant. The participant will stand in tight-fitting clothing at a predefined location in front of a white wall with a calibration pattern. All camera parameters will remain unchanged throughout the study. Photographs will be analyzed using a semi-automated method, and the extent of forward trunk flexion will be classified according to standardized guidelines for axial postural abnormalities in Parkinson's disease.

次要结局

  • Pain Intensity - Numeric Rating Scale(Week 0, week 4, week 8, week 12)
  • MDS-Unified Parkinson's Disease Rating Scale: Part II. and III.(Week 0, week 4, week 8, week 12)
  • Mini-Balance Evaluation Systems Test (Mini-BESTest)(Week 0, week 4, week 8, week 12)
  • The Parkinson's Disease Questionnaire (PDQ-39)(Week 0, week 4, week 8, week 12)
  • Number of Falls in the Previous Month(Week 0, week 4, week 8, week 12)
  • Forced expiratory volume (FEV1)(Week 0, week 4, week 8, week 12.)
  • Forced vital capacity (FVC)(Week 0, week 4, week 8, week 12.)
  • Peak expiratory flow (PEF)(Week 0, week 4, week 8, week 12.)

研究者

发起方
General University Hospital, Prague
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kateřina Dvořáková

Physiotherapist

General University Hospital, Prague

研究点 (1)

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