Parkinson DiseasePhase 1NCT05837520
i-BiSSkApp for Swallowing Rehabilitation in Parkinson's Disease
A Phase 1 study testing i-BiSSkApp (tablet application) with swallowing therapy and Traditional behavioral swallowing therapy in people with Parkinson Disease, run by University of South Florida at 1 site in United States.
Trial summary
Aspiration pneumonia due to dysphagia is a leading cause of death in Parkinson's disease (PD). Dysphagia intervention in the United States involves evaluation at onset of dysphagia symptoms followed by short-term therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- i-BiSSkApp (tablet application) with swallowing therapy and Traditional behavioral swallowing therapy
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 31 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PD by a fellowship trained movement disorders neurologist
- Able to provide informed consent.
- Older than 18 years of age.
- Evidence of oropharyngeal swallowing deficits as determined during a standard of care MBSS.
Who cannot join
- Show evidence of cognitive impairment prohibiting completion of self-informed consent.
- Have a history of stroke or other traumatic brain injury.
- Have a history of previous dysphagia treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerity of South Florida
Tampa, Florida, 33612
Stephanie Watts, PhD, 813-821-8012, srandall1@usf.edu
About this study
Official title: At-Home Skill Training Using Biofeedback for Swallowing Rehabilitation in Parkinson's Disease
Aspiration pneumonia due to dysphagia is a leading cause of death in Parkinson's disease (PD). Dysphagia intervention in the United States involves evaluation at onset of dysphagia symptoms followed by short-term therapy. Traditional therapy relies on verbal instruction and low-tech at-home exercise regimens without visual biofeedback; lacking a monitoring of accuracy or strength of exercise. Available biofeedback is office-based, bulky and expensive, thus, not readily used. The Biofeedback in Strength and Skill Training (BiSSKit) is a well-researched office based biofeedback system that has recently been converted into an affordable and accessible home-based application. This study aims to investigate the impact of swallowing therapy using the BiSSKit app on airway protective outcomes in patients with PD. Thirty participants with PD and dysphagia will be recruited for this study. Participants will undergo a baseline-modified barium swallowing (MBS) evaluation followed by 12 weekly sessions of swallowing therapy. Participants will be randomized to two swallowing therapy groups (1) traditional (2) BiSSKit app. Participants will undergo MBS following therapy completion. Outcome measures include swallowing safety, pharyngeal kinematics, and swallowing-related quality of life. We hypothesize that use of the BiSSKit will result in improved swallowing function compared to the traditional swallowing therapy group.
Read the detailed description
Dysphagia, or disordered swallowing, is prevalent in almost all neurodegenerative conditions and results in the inability to effectively protect the lower airways from foreign (i.e., food/liquid) and endogenous (i.e., saliva) material [1-3]. An unfortunate consequence of dysphagia is aspiration pneumonia, which is a leading cause of death in Parkinson's disease (PD) [4-6]. Swallowing therapy has proven to be effective for the management of dysphagic symptoms in PD. Treatment is most often delivered in clinics once/week over short time periods with the expectation that exercises be completed at-home. However, these paradigms lack biofeedback to assess the accuracy and strength of the prescribed exercise and accountability to ensure completion of the exercise program. Without biofeedback or options for long-term therapeutic intervention at-home, patients often regress to baseline levels [7-9]. The proposed research project seeks to test the effectiveness of a novel at-home surface electromyography (sEMG) biofeedback therapy tool called Biofeedback in Strength and Skill Training (BiSSKit) on swallowing safety and efficiency in patients with PD. The significance of this project lies in the fact that dysphagia is expensive in terms of patient quality of life, health outcomes, and healthcare costs [10, 11] often increasing hospital costs by approximately 40% [12]. Thus, a targeted swallowing therapy system with biofeedback that can be utilized at-home may reduce hospitalizations secondary to dysphagia, help maintain therapeutic gains, and reduce the burden that dysphagia places on our healthcare system.
sEMG is a therapy tool that has been used in rehabilitation practice for decades. Use of sEMG during swallowing therapy involves placement of electrodes under the chin (overlying the anterior belly of the digastric, mylohyoid and geniohyoid muscles) [13]. While the patient completes a swallowing task, electrodes detect collective muscle contractions associated with hyolaryngeal excursion - a biomechanical event critically important to airway safety and swallowing efficiency [14]. The patient can then see the waveform of the swallow displayed on a computer monitor. Measures of swallowing "strength" are derived from the amplitude of the waveform. sEMG hardware and associated software available in the marketplace today is cost prohibitive and thus, in the United States, only available for office-based swallowing intervention.
sEMG provides external biofeedback regarding swallowing parameters by activating neural networks controlling both motor execution and imagery of the act of swallowing including the pre- and postcentral gyrus, inferior frontal gyrus, basal ganglia, insula, and cerebellum [15]. Research has shown that exercise programs incorporating biofeedback promote significant physiologic change that is maintained over time in patients with dysphagia [14, 16-18]. Patients with PD benefit greatly from biofeedback exercises for respiratory muscle strength and lingual strengthening programs and have even been found to maintain the gains made in therapy with at-home programs [7, 16, 19].
A limitation of the currently available sEMG programs is that research studies have solely focus on the strength aspects of the swallowing (amplitude of the waveform) while failing to address the dynamic, skill-based parameters such as timing and volitional initiation that is captured in waveform morphology. Skill based swallowing training focuses on the precision of movements; and this is especially important for patients with PD [14]. Additionally, traditional sEMG systems in the US lack the ability for clinicians to modulate swallowing targets during tasks, which, according to principles of neuroplasticity, is essential for maximizing therapeutic results. The BiSSKit program is a well-researched office-based biofeedback system that adheres to principles of neuroplasticity and incorporates skill training in addition to strength training [14]. Developed in New Zealand and recently approved by the US FDA, this program has been converted into an affordable and accessible home-based application for tablet computers. This hybrid BiSSKiT system incorporates clinical visits and home-based skill/strength training and shows promise to change current therapy delivery models. Although exciting, there is a paucity of data regarding the use of the BiSSKiT with daily home therapy focused on strength and skill based swallowing training on changes to swallowing safety and efficiency in people with PD. This study seeks to evaluate the impact of this device on swallowing outcomes compared to traditional swallowing therapy models in PD.
- Conditions
- Parkinson Disease
- Being tested
- i-BiSSkApp (tablet application) with swallowing therapy, Traditional behavioral swallowing therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-BiSSkApp (tablet application) with swallowing therapyDevice
The device, "International Biofeedback Strength and Skill App (i-BiSSkApp)" is an at-home swallowing biofeedback tool (hardware and software) to target rehabilitation of both skill and strength of swallowing function. The program utilizes submental surface electromyography coupled with a user-friendly interface to display visual feedback of swallowing strength and timing.
Traditional behavioral swallowing therapyBehavioural
Participants will receive standard behavioral swallowing exercises based on the results of a swallowing evaluation. Participants will complete daily at-home exercises with written and verbal instructions and return weekly to clinic for 12 weeks of therapy.
| Study group | Role | What they receive |
|---|---|---|
| i-BiSSkApp Group | Experimental | This group will complete daily swallowing behavioral exercises with simultaneous at-home sEMG biofeedback using a tablet application. Participants will participate in weekly clinic visits and at-home therapy for 12 weeks. Receives: Device: i-BiSSkApp (tablet application) with swallowing therapy |
| Traditional Treatment | Active comparator | This group will receive traditional swallowing therapy once a week for 12 weeks using standard therapy practices. They will also complete at-home daily practice of these exercises. Receives: Behavioral: Traditional behavioral swallowing therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration Aspiration Scale Score (PAS)
8 point ordinal scale to assess swallowing safety.
Measured: Baseline
Penetration Aspiration Scale Score (PAS)
8 point ordinal scale to assess swallowing safety.
Measured: Post-12 weeks of intervention
Total Pharyngeal Residue
This is the amount of residue within the valleculae and piriform sinuses after the completion of a swallow.
Measured: Baseline
Total Pharyngeal Residue
This is the amount of residue within the valleculae and piriform sinuses after the completion of a swallow.
Measured: Post-12 weeks of intervention
Secondary outcomes (2)
Eating Assessment Tool-10 (EAT-10)
Validated quality of life measure of swallowing function.
Measured: Baseline
Eating Assessment Tool-10 (EAT-10)
Validated quality of life measure of swallowing function.
Measured: Post-12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start15 Jun 2023 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Watts, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837520
- Sponsor's protocol ID
- STUDY005198
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data that underlie results reported in an article, after deidentification (text, tables, figures, and appendices). No specific data will be shared outside of study investigators.
Publications
Tabor-Gray LC, Gallestagui A, Vasilopoulos T, Plowman EK. Characteristics of impaired voluntary cough function in individuals with amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Feb;20(1-2):37-42. doi: 10.1080/21678421.2018.1510011. Epub 2019 Jan 17.
PubMed 30652513Ebihara S, Saito H, Kanda A, Nakajoh M, Takahashi H, Arai H, Sasaki H. Impaired efficacy of cough in patients with Parkinson disease. Chest. 2003 Sep;124(3):1009-15. doi: 10.1378/chest.124.3.1009.
PubMed 12970031Smith Hammond CA, Goldstein LB, Zajac DJ, Gray L, Davenport PW, Bolser DC. Assessment of aspiration risk in stroke patients with quantification of voluntary cough. Neurology. 2001 Feb 27;56(4):502-6. doi: 10.1212/wnl.56.4.502.
PubMed 11222795Fall PA, Saleh A, Fredrickson M, Olsson JE, Granerus AK. Survival time, mortality, and cause of death in elderly patients with Parkinson's disease: a 9-year follow-up. Mov Disord. 2003 Nov;18(11):1312-6. doi: 10.1002/mds.10537.
PubMed 14639673Troche MS, Rosenbek JC, Okun MS, Sapienza CM. Detraining outcomes with expiratory muscle strength training in Parkinson disease. J Rehabil Res Dev. 2014;51(2):305-10. doi: 10.1682/JRRD.2013.05.0101.
PubMed 24933728Crary MA, Carnaby GD, LaGorio LA, Carvajal PJ. Functional and physiological outcomes from an exercise-based dysphagia therapy: a pilot investigation of the McNeill Dysphagia Therapy Program. Arch Phys Med Rehabil. 2012 Jul;93(7):1173-8. doi: 10.1016/j.apmr.2011.11.008. Epub 2012 Feb 25.
PubMed 22365489Crary MA, Carnaby Mann GD, Groher ME, Helseth E. Functional benefits of dysphagia therapy using adjunctive sEMG biofeedback. Dysphagia. 2004 Summer;19(3):160-4. doi: 10.1007/s00455-004-0003-8.
PubMed 15383945Athukorala RP, Jones RD, Sella O, Huckabee ML. Skill training for swallowing rehabilitation in patients with Parkinson's disease. Arch Phys Med Rehabil. 2014 Jul;95(7):1374-82. doi: 10.1016/j.apmr.2014.03.001. Epub 2014 May 9.
PubMed 24816250Jenks J, Pitts LL. Effects of an Intensive Exercise-Based Swallowing Program for Persons With Parkinson's Disease and Complex Medical History: A Single-Case Experiment. Am J Speech Lang Pathol. 2019 Aug 9;28(3):1268-1274. doi: 10.1044/2019_AJSLP-18-0168. Epub 2019 Jul 23.
PubMed 31335179
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- At-Home Skill Training Using Biofeedback for Swallowing Rehabilitation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05837520
- Acronym / sponsor ID
- STUDY005198
- Conditions
- Parkinson Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aspiration pneumonia due to dysphagia is a leading cause of death in Parkinson's disease (PD). Dysphagia intervention in the United States involves evaluation at onset of dysphagia symptoms followed by short-term therapy. Traditional therapy relies on verbal instruction and low-tech at-home exercise regimens without visual biofeedback; lacking a monitoring of accuracy or strength of exercise. Available biofeedback is office-based, bulky and expensive, thus, not readily used. The Biofeedback in Strength and Skill Training (BiSSKit) is a well-researched office based biofeedback system that has recently been converted into an affordable and accessible home-based application. This study aims to investigate the impact of swallowing therapy using the BiSSKit app on airway protective outcomes in patients with PD. Thirty participants with PD and dysphagia will be recruited for this study. Participants will undergo a baseline-modified barium swallowing (MBS) evaluation followed by 12 weekly sessions of swallowing therapy. Participants will be randomized to two swallowing therapy groups (1) traditional (2) BiSSKit app. Participants will undergo MBS following therapy completion. Outcome measures include swallowing safety, pharyngeal kinematics, and swallowing-related quality of life. We hypothesize that use of the BiSSKit will result in improved swallowing function compared to the traditional swallowing therapy group.
Detailed description
Dysphagia, or disordered swallowing, is prevalent in almost all neurodegenerative conditions and results in the inability to effectively protect the lower airways from foreign (i.e., food/liquid) and endogenous (i.e., saliva) material [1-3]. An unfortunate consequence of dysphagia is aspiration pneumonia, which is a leading cause of death in Parkinson's disease (PD) [4-6]. Swallowing therapy has proven to be effective for the management of dysphagic symptoms in PD. Treatment is most often delivered in clinics once/week over short time periods with the expectation that exercises be completed at-home. However, these paradigms lack biofeedback to assess the accuracy and strength of the prescribed exercise and accountability to ensure completion of the exercise program. Without biofeedback or options for long-term therapeutic intervention at-home, patients often regress to baseline levels [7-9]. The proposed research project seeks to test the effectiveness of a novel at-home surface electromyography (sEMG) biofeedback therapy tool called Biofeedback in Strength and Skill Training (BiSSKit) on swallowing safety and efficiency in patients with PD. The significance of this project lies in the fact that dysphagia is expensive in terms of patient quality of life, health outcomes, and healthcare costs [10, 11] often increasing hospital costs by approximately 40% [12]. Thus, a targeted swallowing therapy system with biofeedback that can be utilized at-home may reduce hospitalizations secondary to dysphagia, help maintain therapeutic gains, and reduce the burden that dysphagia places on our healthcare system.
sEMG is a therapy tool that has been used in rehabilitation practice for decades. Use of sEMG during swallowing therapy involves placement of electrodes under the chin (overlying the anterior belly of the digastric, mylohyoid and geniohyoid muscles) [13]. While the patient completes a swallowing task, electrodes detect collective muscle contractions associated with hyolaryngeal excursion - a biomechanical event critically important to airway safety and swallowing efficiency [14]. The patient can then see the waveform of the swallow displayed on a computer monitor. Measures of swallowing "strength" are derived from the amplitude of the waveform. sEMG hardware and associated software available in the marketplace today is cost prohibitive and thus, in the United States, only available for office-based swallowing intervention.
sEMG provides external biofeedback regarding swallowing parameters by activating neural networks controlling both motor execution and imagery of the act of swallowing including the pre- and postcentral gyrus, inferior frontal gyrus, basal ganglia, insula, and cerebellum [15]. Research has shown that exercise programs incorporating biofeedback promote significant physiologic change that is maintained over time in patients with dysphagia [14, 16-18]. Patients with PD benefit greatly from biofeedback exercises for respiratory muscle strength and lingual strengthening programs and have even been found to maintain the gains made in therapy with at-home programs [7, 16, 19].
A limitation of the currently available sEMG programs is that research studies have solely focus on the strength aspects of the swallowing (amplitude of the waveform) while failing to address the dynamic, skill-based parameters such as timing and volitional initiation that is captured in waveform morphology. Skill based swallowing training focuses on the precision of movements; and this is especially important for patients with PD [14]. Additionally, traditional sEMG systems in the US lack the ability for clinicians to modulate swallowing targets during tasks, which, according to principles of neuroplasticity, is essential for maximizing therapeutic results. The BiSSKit program is a well-researched office-based biofeedback system that adheres to principles of neuroplasticity and incorporates skill training in addition to strength training [14]. Developed in New Zealand and recently approved by the US FDA, this program has been converted into an affordable and accessible home-based application for tablet computers. This hybrid BiSSKiT system incorporates clinical visits and home-based skill/strength training and shows promise to change current therapy delivery models. Although exciting, there is a paucity of data regarding the use of the BiSSKiT with daily home therapy focused on strength and skill based swallowing training on changes to swallowing safety and efficiency in people with PD. This study seeks to evaluate the impact of this device on swallowing outcomes compared to traditional swallowing therapy models in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-BiSSkApp Group | Experimental | Device: i-BiSSkApp (tablet application) with swallowing therapyThis group will complete daily swallowing behavioral exercises with simultaneous at-home sEMG biofeedback using a tablet application. Participants will participate in weekly clinic visits and at-home therapy for 12 weeks. |
| Traditional Treatment | Active comparator | Behavioral: Traditional behavioral swallowing therapyThis group will receive traditional swallowing therapy once a week for 12 weeks using standard therapy practices. They will also complete at-home daily practice of these exercises. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PD by a fellowship trained movement disorders neurologist
- Able to provide informed consent.
- Older than 18 years of age.
- Evidence of oropharyngeal swallowing deficits as determined during a standard of care MBSS.
Key exclusion criteria (3 listed)
- Show evidence of cognitive impairment prohibiting completion of self-informed consent.
- Have a history of stroke or other traumatic brain injury.
- Have a history of previous dysphagia treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-BiSSkApp (tablet application) with swallowing therapyThe device, "International Biofeedback Strength and Skill App (i-BiSSkApp)" is an at-home swallowing biofeedback tool (hardware and software) to target rehabilitation of both skill and strength of swallowing function. The program utilizes submental surface electromyography coupled with a user-friendly interface to display visual feedback of swallowing strength and timing. | Device | i-BiSSkApp Group |
| Traditional behavioral swallowing therapyParticipants will receive standard behavioral swallowing exercises based on the results of a swallowing evaluation. Participants will complete daily at-home exercises with written and verbal instructions and return weekly to clinic for 12 weeks of therapy. | Behavioural | Traditional Treatment |
Primary outcome
Penetration Aspiration Scale Score (PAS)
Time frame: Baseline
8 point ordinal scale to assess swallowing safety.
Penetration Aspiration Scale Score (PAS)
Time frame: Post-12 weeks of intervention
8 point ordinal scale to assess swallowing safety.
Total Pharyngeal Residue
Time frame: Baseline
This is the amount of residue within the valleculae and piriform sinuses after the completion of a swallow.
Total Pharyngeal Residue
Time frame: Post-12 weeks of intervention
This is the amount of residue within the valleculae and piriform sinuses after the completion of a swallow.
2 secondary outcomes
Eating Assessment Tool-10 (EAT-10)
Time frame: Baseline
Eating Assessment Tool-10 (EAT-10)
Time frame: Post-12 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Background: PubMed 30652513Tabor-Gray LC, Gallestagui A, Vasilopoulos T, Plowman EK. Characteristics of impaired voluntary cough function in individuals with amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2019 Feb;20(1-2):37-42. doi: 10.1080/21678421.2018.1510011. Epub 2019 Jan 17.
- Background: PubMed 12970031Ebihara S, Saito H, Kanda A, Nakajoh M, Takahashi H, Arai H, Sasaki H. Impaired efficacy of cough in patients with Parkinson disease. Chest. 2003 Sep;124(3):1009-15. doi: 10.1378/chest.124.3.1009.
- Background: PubMed 11222795Smith Hammond CA, Goldstein LB, Zajac DJ, Gray L, Davenport PW, Bolser DC. Assessment of aspiration risk in stroke patients with quantification of voluntary cough. Neurology. 2001 Feb 27;56(4):502-6. doi: 10.1212/wnl.56.4.502.
- Background: PubMed 14639673Fall PA, Saleh A, Fredrickson M, Olsson JE, Granerus AK. Survival time, mortality, and cause of death in elderly patients with Parkinson's disease: a 9-year follow-up. Mov Disord. 2003 Nov;18(11):1312-6. doi: 10.1002/mds.10537.
- Background: PubMed 24933728Troche MS, Rosenbek JC, Okun MS, Sapienza CM. Detraining outcomes with expiratory muscle strength training in Parkinson disease. J Rehabil Res Dev. 2014;51(2):305-10. doi: 10.1682/JRRD.2013.05.0101.
- Background: PubMed 22365489Crary MA, Carnaby GD, LaGorio LA, Carvajal PJ. Functional and physiological outcomes from an exercise-based dysphagia therapy: a pilot investigation of the McNeill Dysphagia Therapy Program. Arch Phys Med Rehabil. 2012 Jul;93(7):1173-8. doi: 10.1016/j.apmr.2011.11.008. Epub 2012 Feb 25.
- Background: PubMed 15383945Crary MA, Carnaby Mann GD, Groher ME, Helseth E. Functional benefits of dysphagia therapy using adjunctive sEMG biofeedback. Dysphagia. 2004 Summer;19(3):160-4. doi: 10.1007/s00455-004-0003-8.
- Background: PubMed 24816250Athukorala RP, Jones RD, Sella O, Huckabee ML. Skill training for swallowing rehabilitation in patients with Parkinson's disease. Arch Phys Med Rehabil. 2014 Jul;95(7):1374-82. doi: 10.1016/j.apmr.2014.03.001. Epub 2014 May 9.
- Background: PubMed 31335179Jenks J, Pitts LL. Effects of an Intensive Exercise-Based Swallowing Program for Persons With Parkinson's Disease and Complex Medical History: A Single-Case Experiment. Am J Speech Lang Pathol. 2019 Aug 9;28(3):1268-1274. doi: 10.1044/2019_AJSLP-18-0168. Epub 2019 Jul 23.
- Individual participant dataSharing planned: No. Individual participant data that underlie results reported in an article, after deidentification (text, tables, figures, and appendices). No specific data will be shared outside of study investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Watts, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing i-BiSSkApp (tablet application) with swallowing therapy and Traditional behavioral swallowing therapy in people with Parkinson Disease, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie A Watts, PhD (813-821-8012, srandall1@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration Aspiration Scale Score (PAS) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05837520, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.