Continuous Rhythmic Auditory StimulationNCT03316365
Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
A study testing Rhythmic Auditory Stimulation (RAS) in people with Continuous Rhythmic Auditory Stimulation and Intermittent Rhythmic Auditory Stimulation, run by University of Toronto.
Trial summary
Falls are common among patients with Parkinson's Disease (PD) and are the biggest contributors to loss of independent living, long-term institutionalization, and increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Rhythmic Auditory Stimulation, Intermittent Rhythmic Auditory Stimulation
- What is being tested?
- Rhythmic Auditory Stimulation (RAS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2009to Aug 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hoehn \& Yahr (HY) stage III or IV
- At least 2 falls in the past 12 months
- Stable antiparkinsonian medication regime
- Ability to ambulate independently for at least 50 m.
Who cannot join
- Other neurological or orthopedic conditions
- Medically diagnosed hearing loss
- Dementia (Mini Mental Status Exam score < 24).
About this study
Falls are common among patients with Parkinson's Disease (PD) and are the biggest contributors to loss of independent living, long-term institutionalization, and increased mortality.
The purpose of this study was to explore whether an at-home based Rhythmic Auditory Stimulation (RAS) gait training program will decrease the number of falls in persons with PD with a history of falling. We also evaluated changes in clinical and kinematic parameters used to assess fall risk in this population.
Sixty participants diagnosed with idiopathic PD with at least 2 falls in the past 12 months, were randomly allocated into two groups. The experimental group trained daily with RAS for 24 weeks. The control group also trained daily with RAS, but discontinued training between weeks 8 and 16. During treatment patients walked for 30 minutes in a home based environment with metronome-click embedded music. Changes in clinical and kinematic parameters were assessed at baseline, weeks 8, 16, and 24.
- Being tested
- Rhythmic Auditory Stimulation (RAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Auditory Stimulation (RAS)Other
Also called Neurologic Music Therapy
The experimental group (continuous treatment) trained daily with Rhythmic Auditory Stimulation (RAS) for 24 weeks. The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks. During treatment subjects walked for 30 minutes in a home-based environment with metronome-click embedded music downloaded to an MP3 player and listened to either free-field or via headphones. For the first 8 weeks subjects had 3 metronome rates available to choose from: 100, 105, and 110% of internal usual cadence. During the second 8 weeks available rates were 105, 110 and 115%; and during the last 8 weeks 110, 115, 120%. The control group started their last training segment at 105, 110, and 115%, but could request a change to the faster rates if comfortable.
| Study group | Role | What they receive |
|---|---|---|
| Continuous RAS | Experimental | The experimental group (continuous treatment) trained daily with RAS for 24 weeks. Receives: Other: Rhythmic Auditory Stimulation (RAS) |
| Intermittent RAS | Active comparator | The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks. Receives: Other: Rhythmic Auditory Stimulation (RAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Index
The Fall Index was computed based on self-reports by subjects or caregivers and classified as 1 (incomplete fall, lost balance but stabilized by another person or object), 2 (complete fall, no injuries) or 3 (complete fall, injury, medical attention required). A complete fall was defined as unintentionally coming to the ground with any body part above ankle. Higher Fall Index values indicate higher incidence of falls.
Measured: Change of the number of fall incidents and severity from baseline assessed by the Fall Index 8 weeks, 16 weeks, and 24 weeks.
Secondary outcomes (4)
Falls Efficacy Scale (FES)
Falls Efficacy Scale (FES) (Tinetti et al 1990) is a 10-item scale to assess fear of falling in older persons. Individuals are asked to rate, on a 10-point scale with zero corresponding to not at all and 10 to completely, how confident he or she felt in performing 10 activities. The scores are added up to calculate a total score that ranges from 0 to 100. Higher scores indicate more confidence/less fear.
Measured: Change in level of concern about falling from baseline assessed by Fear of the Falling Questionnaire/Short FES-1 at 8 weeks, 16 weeks, and 24 weeks.
Berg Balance Scale (BBS)
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function, and the final measure is the sum of all of the scores.
Measured: Change in balance from baseline assessed by Berg Balance Scale at 8 weeks, 16 weeks, and 24 weeks.
Timed Up and Go (TUG)
Measure of function (rise from a chair, walk three meters, turn around, walk back to the chair, and sit down) with correlates to balance and fall risk. A faster time indicates a better functional performance.
Measured: Change in balance and function from baseline assessed by Timed Up and Go at 8 weeks, 16 weeks, and 24 weeks.
Gait
Assessment of gait parameters (velocity, stride length, cadence, ankle dorsiflexion) with a computerized stride analyzer system (B\&L Engineering).
Measured: Change in gait from baseline at 8 weeks, 16 weeks, and 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study startAug 2009
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Rhythmic Auditory StimulationStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Poudre Valley Health System Fort Collins CO, Colorado State University
- Responsible party
- Principal investigator, Michael H. Thaut, University of Toronto
- Investigators
- Michael Thaut, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316365
- Sponsor's protocol ID
- 06-785
- Status last verified
- Jun 2018
- First submitted
- 16 Oct 2017
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made available to external researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03316365
- Acronym / sponsor ID
- 06-785
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Poudre Valley Health System Fort Collins CO, Colorado State University
- Study start
- Aug 2009 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Oct 2017 (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.
Falls are common among patients with Parkinson's Disease (PD) and are the biggest contributors to loss of independent living, long-term institutionalization, and increased mortality.
The purpose of this study was to explore whether an at-home based Rhythmic Auditory Stimulation (RAS) gait training program will decrease the number of falls in persons with PD with a history of falling. We also evaluated changes in clinical and kinematic parameters used to assess fall risk in this population.
Sixty participants diagnosed with idiopathic PD with at least 2 falls in the past 12 months, were randomly allocated into two groups. The experimental group trained daily with RAS for 24 weeks. The control group also trained daily with RAS, but discontinued training between weeks 8 and 16. During treatment patients walked for 30 minutes in a home based environment with metronome-click embedded music. Changes in clinical and kinematic parameters were assessed at baseline, weeks 8, 16, and 24.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous RAS | Experimental | Other: Rhythmic Auditory Stimulation (RAS)The experimental group (continuous treatment) trained daily with RAS for 24 weeks. |
| Intermittent RAS | Active comparator | Other: Rhythmic Auditory Stimulation (RAS)The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hoehn \& Yahr (HY) stage III or IV
- At least 2 falls in the past 12 months
- Stable antiparkinsonian medication regime
- Ability to ambulate independently for at least 50 m.
Key exclusion criteria (3 listed)
- Other neurological or orthopedic conditions
- Medically diagnosed hearing loss
- Dementia (Mini Mental Status Exam score < 24).
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 |
|---|---|---|
| Rhythmic Auditory Stimulation (RAS)Also: Neurologic Music TherapyThe experimental group (continuous treatment) trained daily with Rhythmic Auditory Stimulation (RAS) for 24 weeks. The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks. During treatment subjects walked for 30 minutes in a home-based environment with metronome-click embedded music downloaded to an MP3 player and listened to either free-field or via headphones. For the first 8 weeks subjects had 3 metronome rates available to choose from: 100, 105, and 110% of internal usual cadence. During the second 8 weeks available rates were 105, 110 and 115%; and during the last 8 weeks 110, 115, 120%. The control group started their last training segment at 105, 110, and 115%, but could request a change to the faster rates if comfortable. | Other | Continuous RAS, Intermittent RAS |
Primary outcome
Fall Index
Time frame: Change of the number of fall incidents and severity from baseline assessed by the Fall Index 8 weeks, 16 weeks, and 24 weeks.
The Fall Index was computed based on self-reports by subjects or caregivers and classified as 1 (incomplete fall, lost balance but stabilized by another person or object), 2 (complete fall, no injuries) or 3 (complete fall, injury, medical attention required). A complete fall was defined as unintentionally coming to the ground with any body part above ankle. Higher Fall Index values indicate higher incidence of falls.
4 secondary outcomes
Falls Efficacy Scale (FES)
Time frame: Change in level of concern about falling from baseline assessed by Fear of the Falling Questionnaire/Short FES-1 at 8 weeks, 16 weeks, and 24 weeks.
Berg Balance Scale (BBS)
Time frame: Change in balance from baseline assessed by Berg Balance Scale at 8 weeks, 16 weeks, and 24 weeks.
Timed Up and Go (TUG)
Time frame: Change in balance and function from baseline assessed by Timed Up and Go at 8 weeks, 16 weeks, and 24 weeks.
Gait
Time frame: Change in gait from baseline at 8 weeks, 16 weeks, and 24 weeks.
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 21 Jun 2018.
- Individual participant dataSharing planned: No. IPD will not be made available to external researchers.
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.
Michael Thaut, PhD principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Auditory Stimulation (RAS) in people with Continuous Rhythmic Auditory Stimulation and Intermittent Rhythmic Auditory Stimulation, run by University of Toronto.
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: finished, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Fall Index (time frame: Change of the number of fall incidents and severity from baseline assessed by the Fall Index 8 weeks, 16 weeks, and 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2018.