Parkinson DiseasePhase 1NCT05733819
Responders to Rhythmic Auditory Cueing in Parkinson Disease
A Phase 1 study testing Subject-specific optimized RAS and Active Walking in people with Parkinson Disease, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Parkinson disease (PD) is the second most common neurodegenerative disease affecting approximately 10 million people worldwide. It is a complex movement disorder that results in reduced walking ability. Prior studies have identified declines in walking as a marker of ensuing disability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Subject-specific optimized RAS and Active Walking
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 30 Jun 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to communicate with investigators clearly
- Diagnosis of Parkinson's disease (self-report)
- The ability to walk continuously without another individual supporting the person's body weight for at least 6 minutes. Assistive devices, such as a cane, are allowed.
Who cannot join
- Inability to communicate (as assessed by a licensed physical therapist)
- Parkinson's disease, score < 23 on the MMSE.
- Pain that impairs walking ability (as assessed by a licensed physical therapist)
- Unexplained dizziness in the last 6 months (self-report)
- Severe comorbidities that may interfere with the ability to participate (musculoskeletal, cardiovascular, pulmonary, and neurological)
- More than 2 falls in the previous month
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Neuromotor Recovery Laboratory
Boston, Massachusetts, 02215
About this study
Official title: Responders to Metronome-based Rhythmic Auditory Cueing in Parkinson Disease
Parkinson disease (PD) is the second most common neurodegenerative disease affecting approximately 10 million people worldwide. It is a complex movement disorder that results in reduced walking ability. Prior studies have identified declines in walking as a marker of ensuing disability. Rhythmic auditory stimulation (RAS) is a rehabilitation approach that employs the coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting regular moderate-intensity walking activity -- an important health objective in the management of PD. However, there is limited research investigating the effects of RAS on walking quality and how improvements in walking speed are achieved. This study will enroll 30 individuals with mild to moderate PD where each participant will be asked to complete two six-minute walk tests, one standard test (baseline) and the other using an optimized metronome-based auditory cueing RAS intervention. The investigators hypothesize that individuals with PD will either walk farther or with more automaticity (i.e., reduced stride time variability) in the RAS condition compared to the baseline condition. Moreover, these walking improvements will be accompanied by improvements in gait mechanics and metabolic cost of walking.
Read the detailed description
Parkinson Disease (PD) is one of the fastest-growing sources of disability among neurological populations. PD is a progressive movement disorder characterized by substantial walking-related disability. Loss of function and quality of walking can subsequently lead to declines in walking which can precipitate a cycle of disability and deconditioning. In particular, persons with PD often demonstrate a reduction in stride length and an increase in stride time variability. These gait changes can reduce mobility and increase the risk of falls. Improving walking has been identified as the greatest priority among persons with PD for improving independence and quality of life. Therefore, interventions targeting improvements in walking function and gait quality are needed to mitigate a walking-related disability.
Rhythmic Auditory Stimulation (RAS) is a rehabilitation intervention that, unlike pharmacologic treatment, has shown promise for improving walking in PD. Walking with RAS intervention has been shown to improve walking function, particularly walking speed. RAS relies on the robust human capacity to synchronize movements to an external rhythm (i.e., walking to a regular auditory beat), a process referred to as auditory-motor entrainment. Due to the body's preference to select a walking frequency that maximizes stability and minimizes energy expenditure, rhythmic entrainment may stabilize gait patterns and reduce the metabolic cost of walking. Moreover, rhythmic entrainment is thought to reduce the attentional demand of walking in persons with PD, allowing for attention to be allocated to secondary tasks essential for safe community navigation. Despite evidence of the effectiveness of improving walking speed and gait function, the biomechanical changes that enable this improvement are not well understood.
Moreover, while RAS is an effective treatment, not everyone benefits from the treatment equally. Individuals with PD have a wide variety of gait presentations, and gait impairment may affect the efficacy of RAS treatment. In this study, the investigators want to understand who responds to RAS interventions and if the investigators can identify these responders from baseline measurements. For this analysis, the investigators define responders in three ways: (1) individuals who increase walking function, (2) individuals who increase gait quality, or (3) individuals who increase both gait quality and walking function while walking to personalized RAS. The investigators hypothesize that individuals who increase walking function and/or gait quality while walking to personalized RAS are more likely to be responsive to long-term intervention with RAS; however, the mechanism of action that enables the long-term response is hypothesized to be different based on baseline deficits. The investigators posit that the short-term responses to RAS measured in this study may suggest potential long-term mechanisms.
Study Protocol:
To examine the different effects of the intervention, each participant will complete a data collection session with a series of clinical tests including the Mini-BEST, UPDRS, the 10-m walk test (10MWT) at comfortable and fast walking speed, and the 6-minute walk test (6MWT) to quantity baseline function. Moreover, the 6MWT will be fully instrumented using motion capture cameras that track retro-reflective markers, wireless inertial measurement units, and force plates embedded in the walkway---together, these systems will enable concurrent collection of gait kinematic, inertial, and kinetic signals respectively. Additionally, metabolic measures will be collected during the 6MWT. After the baseline 6-minute walk test, participants will wear a custom, simple RAS device that will use a metronome application and bone-conducting headphones to provide auditory cues designed to modulate the participant's walking cadence. The auditory cues provided will be subject-specific based on a tuning procedure. Finally, the 6MWT will be repeated with RAS set to the optimally selected cadence based on the tuning procedure.
The primary objective of this study is to determine the effect of personalized RAS on walking function (i.e., 6MWT total distance) and gait quality (i.e., stride time variability). The investigators will also evaluate RAS-induced changes in other, secondary gait quality metrics: (1) the metabolic cost of transport, (2) walking ground reaction forces, (3) joint kinetics, and (4) distance-induced changes in spatial-temporal gait parameters. A secondary objective is to determine if RAS-induced changes in walking function and/or gait quality are related to specific patterns of baseline walking and gait impairment (i.e., movement phenotypes).
- Conditions
- Parkinson Disease
- Being tested
- Subject-specific optimized RAS, Active Walking
- Keywords
- rhythmic auditory stimulation (RAS), gait analysis
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subject-specific optimized RASDevice
Also called RAS
Walking with metronome-based RAS cueing
Active WalkingBehavioural
Walking without RAS cueing
| Study group | Role | What they receive |
|---|---|---|
| Walking without personalized rhythmic auditory stimulation | Active comparator | Subjects will complete a 6MWT without any auditory cues Receives: Behavioral: Active Walking |
| Walking with personalized rhythmic auditory stimulation | Experimental | Subjects will complete a 6MWT with personalized rhythmic auditory cues Receives: Device: Subject-specific optimized RAS; Behavioral: Active Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six Minute Walk test distance
difference in total distance walked with and without RAS. (m)
Measured: [RAS-Baseline]
Stride time variability
difference in stride time variability with and without RAS (%)
Measured: [RAS-Baseline]
Secondary outcomes (6)
Metabolic Cost of Transport
difference in energy cost of walking with and without RAS. Metabolic cost of transport is defined as metabolic energy (measured directly from COSMED) per kg of body weight (in mL/s/kg or W/kg) divided by the average speed during the six minute walk test (mL/kg/m or J/kg/m).
Measured: [RAS-Baseline]
Ground Reaction Forces
difference in Anterior Posterior GRF -- including both peak and impulse (%bw)
Measured: [RAS-Baseline]
Joint power
difference in joint power computed using inverse dynamics -- including ankle, knee, and hip moment. (W/kg)
Measured: [RAS-Baseline]
speed changes over the 6MWT
the difference in changes in walking speed over the 6MWT (m/s)
Measured: [RAS-Baseline]
stride length changes over the 6MWT
the difference in changes in stride length over the 6MWT (cm)
Measured: [RAS-Baseline]
cadence changes over the 6MWT
the difference in changes in cadence over the 6MWT (steps/min)
Measured: [RAS-Baseline]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start17 Jan 2023
- Primary completion20 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Subjects will complete a 6MWT without RAS and then complete a 6MWT with RAS
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Terry Ellis, PT, PhD
- Responsible party
- Principal investigator, Lou Awad, PT, DPT, PhD, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733819
- Sponsor's protocol ID
- 4440-PD
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified subject data with and without RAS may be published as part of the manuscript. Data may include, kinematics, kinetics, metabolic and clinical data.
Publications
Shulman LM, Gruber-Baldini AL, Anderson KE, Vaughan CG, Reich SG, Fishman PS, Weiner WJ. The evolution of disability in Parkinson disease. Mov Disord. 2008 Apr 30;23(6):790-6. doi: 10.1002/mds.21879.
PubMed 18361474Shulman LM. Understanding disability in Parkinson's disease. Mov Disord. 2010;25 Suppl 1:S131-5. doi: 10.1002/mds.22789.
PubMed 20187231Lord S, Godfrey A, Galna B, Mhiripiri D, Burn D, Rochester L. Ambulatory activity in incident Parkinson's: more than meets the eye? J Neurol. 2013 Dec;260(12):2964-72. doi: 10.1007/s00415-013-7037-5. Epub 2013 Jul 31.
PubMed 23900754Cavanaugh JT, Ellis TD, Earhart GM, Ford MP, Foreman KB, Dibble LE. Capturing ambulatory activity decline in Parkinson's disease. J Neurol Phys Ther. 2012 Jun;36(2):51-7. doi: 10.1097/NPT.0b013e318254ba7a.
PubMed 22592060Cochen De Cock V, Dotov D, Damm L, Lacombe S, Ihalainen P, Picot MC, Galtier F, Lebrun C, Giordano A, Driss V, Geny C, Garzo A, Hernandez E, Van Dyck E, Leman M, Villing R, Bardy BG, Dalla Bella S. BeatWalk: Personalized Music-Based Gait Rehabilitation in Parkinson's Disease. Front Psychol. 2021 Apr 26;12:655121. doi: 10.3389/fpsyg.2021.655121. eCollection 2021.
PubMed 33981279Forte R, Tocci N, De Vito G. The Impact of Exercise Intervention with Rhythmic Auditory Stimulation to Improve Gait and Mobility in Parkinson Disease: An Umbrella Review. Brain Sci. 2021 May 22;11(6):685. doi: 10.3390/brainsci11060685.
PubMed 34067458Nonnekes J, Nieuwboer A. Towards Personalized Rehabilitation for Gait Impairments in Parkinson's Disease. J Parkinsons Dis. 2018;8(s1):S101-S106. doi: 10.3233/JPD-181464.
PubMed 30584154Port RJ, Rumsby M, Brown G, Harrison IF, Amjad A, Bale CJ. People with Parkinson's Disease: What Symptoms Do They Most Want to Improve and How Does This Change with Disease Duration? J Parkinsons Dis. 2021;11(2):715-724. doi: 10.3233/JPD-202346.
PubMed 33459664Burrai F, Apuzzo L, Zanotti R. Effectiveness of Rhythmic Auditory Stimulation on Gait in Parkinson Disease: A Systematic Review and Meta-analysis. Holist Nurs Pract. 2024 Mar-Apr 01;38(2):109-119. doi: 10.1097/HNP.0000000000000462. Epub 2021 Jun 11.
PubMed 34121062Ye X, Li L, He R, Jia Y, Poon W. Rhythmic auditory stimulation promotes gait recovery in Parkinson's patients: A systematic review and meta-analysis. Front Neurol. 2022 Jul 28;13:940419. doi: 10.3389/fneur.2022.940419. eCollection 2022.
PubMed 35968291Erra C, Mileti I, Germanotta M, Petracca M, Imbimbo I, De Biase A, Rossi S, Ricciardi D, Pacilli A, Di Sipio E, Palermo E, Bentivoglio AR, Padua L. Immediate effects of rhythmic auditory stimulation on gait kinematics in Parkinson's disease ON/OFF medication. Clin Neurophysiol. 2019 Oct;130(10):1789-1797. doi: 10.1016/j.clinph.2019.07.013. Epub 2019 Jul 25.
PubMed 31401487Nombela C, Hughes LE, Owen AM, Grahn JA. Into the groove: can rhythm influence Parkinson's disease? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2564-70. doi: 10.1016/j.neubiorev.2013.08.003. Epub 2013 Sep 3.
PubMed 24012774Ashoori A, Eagleman DM, Jankovic J. Effects of Auditory Rhythm and Music on Gait Disturbances in Parkinson's Disease. Front Neurol. 2015 Nov 11;6:234. doi: 10.3389/fneur.2015.00234. eCollection 2015.
PubMed 26617566
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responders to Metronome-based Rhythmic Auditory Cueing in Parkinson Disease
- ClinicalTrials.gov ID
- NCT05733819
- Acronym / sponsor ID
- 4440-PD
- Conditions
- Parkinson Disease
- Keywords
- rhythmic auditory stimulation (RAS), gait analysis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- Terry Ellis, PT, PhD
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 17 Feb 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.
Parkinson disease (PD) is the second most common neurodegenerative disease affecting approximately 10 million people worldwide. It is a complex movement disorder that results in reduced walking ability. Prior studies have identified declines in walking as a marker of ensuing disability. Rhythmic auditory stimulation (RAS) is a rehabilitation approach that employs the coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting regular moderate-intensity walking activity -- an important health objective in the management of PD. However, there is limited research investigating the effects of RAS on walking quality and how improvements in walking speed are achieved. This study will enroll 30 individuals with mild to moderate PD where each participant will be asked to complete two six-minute walk tests, one standard test (baseline) and the other using an optimized metronome-based auditory cueing RAS intervention. The investigators hypothesize that individuals with PD will either walk farther or with more automaticity (i.e., reduced stride time variability) in the RAS condition compared to the baseline condition. Moreover, these walking improvements will be accompanied by improvements in gait mechanics and metabolic cost of walking.
Detailed description
Parkinson Disease (PD) is one of the fastest-growing sources of disability among neurological populations. PD is a progressive movement disorder characterized by substantial walking-related disability. Loss of function and quality of walking can subsequently lead to declines in walking which can precipitate a cycle of disability and deconditioning. In particular, persons with PD often demonstrate a reduction in stride length and an increase in stride time variability. These gait changes can reduce mobility and increase the risk of falls. Improving walking has been identified as the greatest priority among persons with PD for improving independence and quality of life. Therefore, interventions targeting improvements in walking function and gait quality are needed to mitigate a walking-related disability.
Rhythmic Auditory Stimulation (RAS) is a rehabilitation intervention that, unlike pharmacologic treatment, has shown promise for improving walking in PD. Walking with RAS intervention has been shown to improve walking function, particularly walking speed. RAS relies on the robust human capacity to synchronize movements to an external rhythm (i.e., walking to a regular auditory beat), a process referred to as auditory-motor entrainment. Due to the body's preference to select a walking frequency that maximizes stability and minimizes energy expenditure, rhythmic entrainment may stabilize gait patterns and reduce the metabolic cost of walking. Moreover, rhythmic entrainment is thought to reduce the attentional demand of walking in persons with PD, allowing for attention to be allocated to secondary tasks essential for safe community navigation. Despite evidence of the effectiveness of improving walking speed and gait function, the biomechanical changes that enable this improvement are not well understood.
Moreover, while RAS is an effective treatment, not everyone benefits from the treatment equally. Individuals with PD have a wide variety of gait presentations, and gait impairment may affect the efficacy of RAS treatment. In this study, the investigators want to understand who responds to RAS interventions and if the investigators can identify these responders from baseline measurements. For this analysis, the investigators define responders in three ways: (1) individuals who increase walking function, (2) individuals who increase gait quality, or (3) individuals who increase both gait quality and walking function while walking to personalized RAS. The investigators hypothesize that individuals who increase walking function and/or gait quality while walking to personalized RAS are more likely to be responsive to long-term intervention with RAS; however, the mechanism of action that enables the long-term response is hypothesized to be different based on baseline deficits. The investigators posit that the short-term responses to RAS measured in this study may suggest potential long-term mechanisms.
Study Protocol:
To examine the different effects of the intervention, each participant will complete a data collection session with a series of clinical tests including the Mini-BEST, UPDRS, the 10-m walk test (10MWT) at comfortable and fast walking speed, and the 6-minute walk test (6MWT) to quantity baseline function. Moreover, the 6MWT will be fully instrumented using motion capture cameras that track retro-reflective markers, wireless inertial measurement units, and force plates embedded in the walkway---together, these systems will enable concurrent collection of gait kinematic, inertial, and kinetic signals respectively. Additionally, metabolic measures will be collected during the 6MWT. After the baseline 6-minute walk test, participants will wear a custom, simple RAS device that will use a metronome application and bone-conducting headphones to provide auditory cues designed to modulate the participant's walking cadence. The auditory cues provided will be subject-specific based on a tuning procedure. Finally, the 6MWT will be repeated with RAS set to the optimally selected cadence based on the tuning procedure.
The primary objective of this study is to determine the effect of personalized RAS on walking function (i.e., 6MWT total distance) and gait quality (i.e., stride time variability). The investigators will also evaluate RAS-induced changes in other, secondary gait quality metrics: (1) the metabolic cost of transport, (2) walking ground reaction forces, (3) joint kinetics, and (4) distance-induced changes in spatial-temporal gait parameters. A secondary objective is to determine if RAS-induced changes in walking function and/or gait quality are related to specific patterns of baseline walking and gait impairment (i.e., movement phenotypes).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will complete a 6MWT without RAS and then complete a 6MWT with RAS
| Arm | Type | Receives |
|---|---|---|
| Walking without personalized rhythmic auditory stimulation | Active comparator | Behavioral: Active WalkingSubjects will complete a 6MWT without any auditory cues |
| Walking with personalized rhythmic auditory stimulation | Experimental | Device: Subject-specific optimized RAS, Behavioral: Active WalkingSubjects will complete a 6MWT with personalized rhythmic auditory cues |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be able to communicate with investigators clearly
- Diagnosis of Parkinson's disease (self-report)
- The ability to walk continuously without another individual supporting the person's body weight for at least 6 minutes. Assistive devices, such as a cane, are allowed.
Key exclusion criteria (6 listed)
- Inability to communicate (as assessed by a licensed physical therapist)
- Parkinson's disease, score < 23 on the MMSE.
- Pain that impairs walking ability (as assessed by a licensed physical therapist)
- Unexplained dizziness in the last 6 months (self-report)
- Severe comorbidities that may interfere with the ability to participate (musculoskeletal, cardiovascular, pulmonary, and neurological)
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 |
|---|---|---|
| Subject-specific optimized RASAlso: RASWalking with metronome-based RAS cueing | Device | Walking with personalized rhythmic auditory stimulation |
| Active WalkingWalking without RAS cueing | Behavioural | Walking with personalized rhythmic auditory stimulation, Walking without personalized rhythmic auditory stimulation |
Primary outcome
Six Minute Walk test distance
Time frame: [RAS-Baseline]
difference in total distance walked with and without RAS. (m)
Stride time variability
Time frame: [RAS-Baseline]
difference in stride time variability with and without RAS (%)
6 secondary outcomes
Metabolic Cost of Transport
Time frame: [RAS-Baseline]
Ground Reaction Forces
Time frame: [RAS-Baseline]
Joint power
Time frame: [RAS-Baseline]
speed changes over the 6MWT
Time frame: [RAS-Baseline]
stride length changes over the 6MWT
Time frame: [RAS-Baseline]
cadence changes over the 6MWT
Time frame: [RAS-Baseline]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Background: PubMed 18361474Shulman LM, Gruber-Baldini AL, Anderson KE, Vaughan CG, Reich SG, Fishman PS, Weiner WJ. The evolution of disability in Parkinson disease. Mov Disord. 2008 Apr 30;23(6):790-6. doi: 10.1002/mds.21879.
- Background: PubMed 20187231Shulman LM. Understanding disability in Parkinson's disease. Mov Disord. 2010;25 Suppl 1:S131-5. doi: 10.1002/mds.22789.
- Background: PubMed 23900754Lord S, Godfrey A, Galna B, Mhiripiri D, Burn D, Rochester L. Ambulatory activity in incident Parkinson's: more than meets the eye? J Neurol. 2013 Dec;260(12):2964-72. doi: 10.1007/s00415-013-7037-5. Epub 2013 Jul 31.
- Background: PubMed 22592060Cavanaugh JT, Ellis TD, Earhart GM, Ford MP, Foreman KB, Dibble LE. Capturing ambulatory activity decline in Parkinson's disease. J Neurol Phys Ther. 2012 Jun;36(2):51-7. doi: 10.1097/NPT.0b013e318254ba7a.
- Background: PubMed 33981279Cochen De Cock V, Dotov D, Damm L, Lacombe S, Ihalainen P, Picot MC, Galtier F, Lebrun C, Giordano A, Driss V, Geny C, Garzo A, Hernandez E, Van Dyck E, Leman M, Villing R, Bardy BG, Dalla Bella S. BeatWalk: Personalized Music-Based Gait Rehabilitation in Parkinson's Disease. Front Psychol. 2021 Apr 26;12:655121. doi: 10.3389/fpsyg.2021.655121. eCollection 2021.
- Background: PubMed 34067458Forte R, Tocci N, De Vito G. The Impact of Exercise Intervention with Rhythmic Auditory Stimulation to Improve Gait and Mobility in Parkinson Disease: An Umbrella Review. Brain Sci. 2021 May 22;11(6):685. doi: 10.3390/brainsci11060685.
- Background: PubMed 30584154Nonnekes J, Nieuwboer A. Towards Personalized Rehabilitation for Gait Impairments in Parkinson's Disease. J Parkinsons Dis. 2018;8(s1):S101-S106. doi: 10.3233/JPD-181464.
- Background: PubMed 33459664Port RJ, Rumsby M, Brown G, Harrison IF, Amjad A, Bale CJ. People with Parkinson's Disease: What Symptoms Do They Most Want to Improve and How Does This Change with Disease Duration? J Parkinsons Dis. 2021;11(2):715-724. doi: 10.3233/JPD-202346.
- Background: PubMed 34121062Burrai F, Apuzzo L, Zanotti R. Effectiveness of Rhythmic Auditory Stimulation on Gait in Parkinson Disease: A Systematic Review and Meta-analysis. Holist Nurs Pract. 2024 Mar-Apr 01;38(2):109-119. doi: 10.1097/HNP.0000000000000462. Epub 2021 Jun 11.
- Background: PubMed 35968291Ye X, Li L, He R, Jia Y, Poon W. Rhythmic auditory stimulation promotes gait recovery in Parkinson's patients: A systematic review and meta-analysis. Front Neurol. 2022 Jul 28;13:940419. doi: 10.3389/fneur.2022.940419. eCollection 2022.
- Background: PubMed 31401487Erra C, Mileti I, Germanotta M, Petracca M, Imbimbo I, De Biase A, Rossi S, Ricciardi D, Pacilli A, Di Sipio E, Palermo E, Bentivoglio AR, Padua L. Immediate effects of rhythmic auditory stimulation on gait kinematics in Parkinson's disease ON/OFF medication. Clin Neurophysiol. 2019 Oct;130(10):1789-1797. doi: 10.1016/j.clinph.2019.07.013. Epub 2019 Jul 25.
- Background: PubMed 24012774Nombela C, Hughes LE, Owen AM, Grahn JA. Into the groove: can rhythm influence Parkinson's disease? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2564-70. doi: 10.1016/j.neubiorev.2013.08.003. Epub 2013 Sep 3.
- Individual participant dataSharing planned: Yes. Deidentified subject data with and without RAS may be published as part of the manuscript. Data may include, kinematics, kinetics, metabolic and clinical data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Subject-specific optimized RAS and Active Walking in people with Parkinson Disease, run by Boston University Charles River Campus 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 18 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six Minute Walk test distance (time frame: [RAS-Baseline]). The study lists 2 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 NCT05733819, which also lists 13 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 18 Mar 2024.