Your Mind Can Exercise Too: Swallowing Motor Imagery Practice
- Conditions
- Dysphagia
- Interventions
- Behavioral: Swallowing exercises
- Registration Number
- NCT06526910
- Lead Sponsor
- Samford University
- Brief 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.
- Detailed Description
The proposed study is a five-site research collaboration between Samford University (Birmingham, AL, Dr. Sarah Szynkiewicz), Case Western Reserve University (Cleveland, OH, Dr. Rachel Mulheren), Emerson College (Boston, MA, Dr. Lindsay Griffin), James Madison University (Harrisonburg, VA, Dr. Erin Kamarunas), and Texas Christian University (Fort Worth, TX, Dr. Teresa Drulia). The Samford IRB serves as the main IRB, with the other sites executing IRB Authorized Agreements with Samford's IRB. The research sessions will be conducted in each site PI's university laboratory and each site PI will be responsible for overseeing the recruitment and data collection at their respective site. Standardized forms and training to both the protocol and data analysis will be completed across all sites and will ensure research fidelity.
The investigators will conduct a multiple baseline single case study (n = 10) to determine feasibility and explore the preliminary effects of motor imagery practice (MIP) on swallowing function in patients with Parkinson's disease (PD). Single case designs are often used as an initial exploration of treatment efficacy prior to a randomized controlled trial. Using this prospective design, participants with PD will complete:
* Phase 1: A four-week period of standard of care dysphagia treatment consisting of physical swallowing-related exercises. According to guidelines for single case design, this standard of care treatment will serve as a baseline/control period for comparison to the subsequent experimental treatment period. Participants will complete either 6, 7, or 8 baseline measurement visits across these 4 weeks (multiple baseline design).
* Phase 2: A three-week wash-out period. All participants will attend 6 measurement sessions across the 3-week period but will not complete any swallowing exercises.
* Phase 3: A four-week exercise period. Five participants will be assigned to complete a second period of standard of care swallowing exercises while the other five will be assigned to the experimental treatment which includes standard of care plus motor imagery practice. According to single case design, participants will complete either 6, 7, or 8 measurement visits across these 4 weeks.
* Phase 4: A final three-week wash-out period. All participants will attend 6 measurement sessions across the 3-week period but will not complete either the standard of care or the experimental swallowing exercises.
The findings of this single case design study will inform the feasibility of methods and provide an estimate of rehabilitation outcomes that will lead to the development of larger randomized controlled clinical trials to determine the efficacy of this promising, novel MIP approach to swallowing rehabilitation in PD and other patient populations with dysphagia. The investigators anticipate this research will confirm the feasibility of using motor imagery practice (MIP) to improve swallowing-related outcomes for patients with Parkinson's disease (PD). The investigators hypothesize that patients with PD will demonstrate a faster rate of improved tongue pressure and spontaneous swallowing frequency during the four-week physical swallowing-related exercise + MIP practice protocol (experimental treatment) compared to the four weeks of physical exercise only (standard of care treatment). Furthermore, the investigators hypothesize that these changes will result in greater improvements in swallowing efficiency and safety (as measured objectively using instrumental swallowing assessment) at the end of treatment. The investigators also expect to provide preliminary evidence that spontaneous swallowing frequency can be used as a measure of functional change in swallowing in patients with PD when instrumental evaluation cannot be accessed or used in repetition.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Phase 1 Standard of Care Swallowing exercises A four-week period of standard of care dysphagia treatment consisting of physical swallowing-related exercises. According to guidelines for single case design, this standard of care treatment will serve as a baseline/control period for comparison to the subsequent experimental treatment period. Participants will complete either 6, 7, or 8 baseline measurement visits across these 4 weeks (multiple baseline design). Phase 3 "Experimental" Swallowing exercises A four-week exercise period. Five participants will be assigned to complete a second period of standard of care swallowing exercises while the other five will be assigned to the experimental treatment which includes standard of care plus motor imagery practice. According to single case design, participants will complete either 6, 7, or 8 measurement visits across these 4 weeks.
- Primary Outcome Measures
Name Time Method Penetration-Aspiration Scale score Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention 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).
- Secondary Outcome Measures
Name Time Method Laryngeal vestibule closure (LVC) reaction time Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention 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.
Spontaneous swallowing frequency Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention 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
Swallowing-related quality-of-life Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention 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).
Tongue pressures 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 Maximum isometric pressure and regular saliva swallow pressure measures (continuous scale, e.g., 0-100+ kilopascals
Dysphagia severity level Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention 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.
Oral transit time Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention 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.
Radboud Oral Motor Inventory for Parkinson's disease (ROMP) Measured at 3 timepoints across the study for each participant: baseline, immediately after Phase 1 intervention, immediately after Phase 3 intervention 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).