Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526910
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Your Mind Can Exercise Too Swallowing Motor Imagery Practice
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Your Mind Can Exercise Too A Novel Application of Motor Imagery Practice in Swallowing Rehabilitation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Swallowing difficulty dysphagia is a clinical symptom of Parkinsons 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 Samfords IRB The research sessions will be conducted in each site PIs 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 Parkinsons 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 baselinecontrol 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 Parkinsons 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
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 Parkinsons 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 baselinecontrol 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 Parkinsons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None