Expiratory Muscle Training and Trunk Flexion in Parkinson's Disease
ConditionParkinson Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral University Hospital, Prague
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Expiratory muscle strength training
DeviceAfter the 4-week wait-to-start period during which they will not receive any intervention, will participants undergo a 4-week respiratory training program using the EMST150™ device (Expiratory Muscle Strength Trainer). EMST therapy sessions will be completed at home on 5 days (of the patients choosing) per week, performing five sets of five forceful exhalations through the EMST150™. The resistance of the device will be set to 75% of the patient's individual maximum expiratory pressure (MEP). The daily training will take approximately 15 minutes. Following the training period, patients will be observed for an additional 4 weeks to assess the sustainability of the potential training effects.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Expiratory Muscle Strength TrainingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in the forward trunk flexion (FTF) angle
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.
Time frame
Week 0, Week 8, Week 12Secondary outcomes
1
MDS-Unified Parkinson's Disease Rating Scale: Part II. and III.
This portion of the scale assesses the motor signs of Parkinson´s disease.The maximum total UPDRS score is 272, indicating the worst possible disability from Parkinson's Disease. The minimum total score is 0, indicating no disability from PD. Improvement greater than (-4.9) points or worsening more than (+4.2) points on MDS-UPDRS II+III represent a minimal clinically important difference.
Time frame
Week 0, week 4, week 8, week 122
Mini-Balance Evaluation Systems Test (Mini-BESTest)
The Mini-BESTest is a comprehensive clinical tool designed to assess balance and postural control. The test consists of 14 tasks, comprising a total of 28 items, each rated from 0 to 2, where 0 indicates severe impairment, 1 indicates moderate impairment and 2 stands for normal performance.
Time frame
Week 0, week 4, week 8, week 123
Pain Intensity - Numeric Rating Scale
Self-reported pain intensity on an 11-point scale (0 = no pain, 10 = worst imaginable pain).
Time frame
Week 0, week 4, week 8, week 124
The Parkinson's Disease Questionnaire (PDQ-39)
The 8-item questionnaire assesses quality of life in people with PD. The minimum score is 0, while the maximum is 100. A higher score indicates a lower quality of life.
Time frame
Week 0, week 4, week 8, week 12Sponsors and contacts
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Source ClinicalTrials.gov
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