Your Mind Can Exercise Too: Swallowing Motor Imagery Practice
NCT Number: NCT06526910
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dysphagia
Interventions: BEHAVIORAL: Swallowing exercises
Sponsor: Samford University
Collaborators: Case Western Reserve University|Emerson College|James Madison University|Texas Christian University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-08
Completion Date: 2024-12

Summary:
Swallowing difficulty (dysphagia) is a clinical symptom of Parkinson's disease (PD) that significantly impacts nutrition, oral secretion management, health status, and quality of life\]. Specific hallmarks of dysphagia in patients with PD include tongue weakness, reduced swallowing frequency and efficiency, and airway invasion. Evidence for effective treatment techniques to address dysphagia in patients with PD is limited and urgently needed, substantiating the systematic study of standard-of-care treatments in this population as well as the development of novel techniques. Motor imagery practice (MIP) is a mentally rehearsed form of exercise that does not involve muscle activation and has been shown to improve motor outcomes in limb rehabilitation. MIP is novel to swallowing rehabilitation. Our group has conducted preliminary MIP studies in healthy older adults and demonstrated improved measures of tongue strength and swallowing pressure when MIP is used in combination with physical tongue exercise compared to physical tongue exercise alone. The next step is to evaluate the use of MIP in patients with dysphagia. The purpose of this research is to determine the feasibility and effect of MIP when added to a physical swallowing-related exercise protocol for patients with PD. Changes in tongue pressure generation, spontaneous swallowing frequency, functional physiological swallowing outcomes, and patient-reported outcomes will be examined. This research aims to fill gaps in evidence specific to dysphagia in patients with PD and to evaluate a novel rehabilitation method. The investigators anticipate that the results of this study will inform clinical practice, with evidence for supporting the improvement of swallowing function and quality of life in patients with PD, and lay the groundwork for the design of future randomized controlled clinical trials.

Primary Outcome Measures: Penetration-Aspiration Scale score, The most severe level of airway invasion will be determined using the Penetration and Aspiration Scale, an eight-point nominal scale (0-8, 8 representing the most severe form of airway invasion) that allows the clinical to define the depth of food/liquid entering the airway and the patient response to it (e.g., coughing)., Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention
Secondary Outcome Measures: Tongue pressures, Maximum isometric pressure and regular saliva swallow pressure measures (continuous scale, e.g., 0-100+ kilopascals, Multiple timepoints across the study as part of the single case series study design, e.g., baseline, up to twice a week during each Phase, post-intervention|Spontaneous swallowing frequency, Spontaneous swallowing frequency will be measured using a microphone and digital voice recorder to record swallowing sounds at rest for a 10-minute period. The audio recording will be analyzed off-line. Continuous scale, e.g. 0-10+ swallows/minute, Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention|Swallowing-related quality-of-life, The participant will complete a self-reported validated swallowing-related quality-of-life questionnaire, The Dysphagia Handicap Index, (25-items with up to 4 points assigned for each question by the participant, 0-100 points, with a higher score indicating a worse quality-of-life rating)., Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention|Radboud Oral Motor Inventory for Parkinson's disease (ROMP), The saliva portion of the ROMP will be completed as a validated patient-reported outcome for oral secretion management. The saliva sub-scale is 9 questions with up to 5 points each assigned by the participants, 0-45 points, with a higher score indicating a worse issue managing saliva)., Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention|Dysphagia severity level, Severity of dysphagia will be determined using the Dysphagia Outcome and Severity Scale, a seven-point ordinal scale allowing the clinician to define the patient's swallowing severity from normal to severely impacted., Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention|Oral transit time, Oral transit time (OTT) reflects the duration (in milliseconds) required to move a bolus through the oral cavity and reflects lingual strength and coordination. OTT will be defined as the time interval between the beginning of posterior bolus movement in the oral cavity to when the bolus tail passes the posterior nasal spine indicating the bolus has passed through the oral cavity. Longer oral transit times suggest reduced swallowing efficiency., Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention|Laryngeal vestibule closure (LVC) reaction time, LVC reaction time reflects the time required for the laryngeal vestibule to close once the swallowing reflex has been initiated. LVC reaction time will be defined as the time interval between when the hyoid has the initial anterior-superior "jump" and the first frame showing contact (or maximum approximation) between the arytenoid process and the inferior surface of the epiglottis. Longer LVC reaction times suggest reduced swallowing safety., Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention