Emory University, Executive Park, Wesley Woods
Atlanta, Georgia, 30329, United States
Location status: Recruiting
NCT Number: NCT07697664
This study is being done to answer the question: Do people with Parkinson's benefit from a new stepping therapy, and how do people with Parkinson's best learn new steps and rhythms set to music? Researchers will also compare individuals with Parkinson's Disease with people with Mild Cognitive Impairment, and with people with neither of these conditions.
The purpose of this study is to identify principles of human-music interactions to establish underlying guiding theories for application to music-based rehabilitation for older populations with neurodegenerative disease, leading to more refined and targeted music-based rhythmic movement therapies.
Interested in participating?
Request Info18 year–79 year
All sexes
Interventional
Not applicable
Atlanta, Georgia, 30329, United States
Location status: Recruiting
This study aims to analyze the effects of an innovative rehabilitation intervention comprising complex rhythmic movement sequence (CRMS) rehabilitation (aka, Spatiotemporal Activity Modification (STEAM)) training for adults. The central hypothesis is that the spatial and temporal components of CRMS are learned at slower rates in mild cognitive impairment (MCI) than in controls, and that CRMS-based rehabilitation strategies can improve cognitive and mobility status in MCI. Researchers hypothesize that people with cognitive impairment or Parkinson's disease (PD) will show reduced capacity and slower responses when modulating their movements to auditory cues encoded within complex musical-rhythmic patterns.
Musical rhythm, which includes the timing and pattern of sound in music, can be communicated through touch or via audible cues.
Objective 1: Evaluate the hypothesis that people with cognitive impairment or Parkinson's disease (PD) will show reduced capacity and slower responses when modulating their movements to auditory cues encoded within complex musical-rhythmic patterns.
Aim 1. Determine whether the temporal and spatial components of movement are learned at different timescales during human-music movement sequence learning.
Researchers will draw on research in music theory to develop a novel, task-specific set of musical patterns that map and facilitate learning of complex spatiotemporal rhythms during walking tasks. The research team will measure spatial, temporal, and kinematic variables during the physical human-music interaction and will alter combinations of spatial and temporal relationships within movements, in healthy younger (18-35 years), a subset of whom (n=10) are experienced dancers, and individuals (age older than 50 years), individuals with MCI, and individuals with PD. Researchers will analyze data from single-session time courses of learning rhythm, within-session changes, and short-term (24-hour) retention.
Hypothesis: Compared to healthy older adults and younger adults, older adults with MCI and older adults with PD will show (H1a) smaller magnitude and slower learning rates for spatial and temporal movement components, and (H1b) greater challenge with learning-coupled spatio-temporal (more complex) rhythmic movements versus spatial or temporal rhythmic movement components alone. Data from the subset of experienced dancers will help us establish biomechanical markers of expert performance.
Objective 2: Evaluate the preliminary effects, safety, acceptability, and tolerability of rhythmic movement training in healthy younger adults, healthy older adults, older adults with mild cognitive impairment, and older adults with Parkinson's disease.
Aim 2: Explore the thoughts, perceptions, and attitudes of people with MCI and their caregivers, regarding their relationship to music, to dance, and a therapeutic program involving popular music, rhythm, and movement sequences designed for people with MCI.
Aim 2 Approach: Participants with MCI will be interviewed for their thoughts, perceptions, and attitudes regarding CRMS.
Aim 3: Evaluate the feasibility and preliminary effects of a 3-week daily (e.g., 3-5 times per week; 1.5-hour classes) program of varied rhythmic movement sequences performed to music for people with MCI and people with PD.
Researchers will also assess participants before and after the program for clinical, biomechanical, functional, and cognitive measures. Intensive programs have previously been shown to be feasible and effective for similar forms of training and will allow efficient collection of data as well as testing of a useful schedule of treatment.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Young adults and adults with normal cognition (NC):
Inclusion criteria
for Older Adults:
Exclusion criteria
for all groups:
Researchers will establish complex rhythmic movement sequences (CRMS) as an experimental paradigm to identify spatial and temporal components and learning time courses of complex rhythmic movement.
Participants will dance with new partners every 15-20 minutes, a widely practiced method of the dance community to enhance learning. The class format is:
Participants dance both leading and following roles, learn how to interpret motor goals through touch, and perform activities to foster understanding of the temporal relationship of movement to music.
Other names: Spatiotemporal activity modification (STEAM)
Time frame: Baseline and post-intervention (3 to 5 weeks)
The Four Square Step Test (FSST) assesses mechanisms underlying motor-cognitive integration. FSST requires participants to step clockwise, then counterclockwise, into four squares created by rods arranged on the ground in a cross. Participants are instructed to perform FSST "as quickly and as safely as you can," not to touch the rods, and to make both feet contact the floor in each square. Timing begins when the participant initiates movement and stops when both feet are back in the starting square after completing the sequence. Trials will be repeated if the participant does not understand the instructions, fails to complete the sequence accurately, loses balance, or touches a rod. Three successful trials will be recorded, and the fastest time selected for analysis. Lower scores are better.
Time frame: Baseline and post-intervention (3 to 5 weeks)
Gait speed testing (Forward/Backwards/Fast): How quickly a person can walk within a specific distance forward and Backwards using GAITRite. GAITRite is a pressure-sensitive walkway that can assess gait anomalies. Lower scores are better.
Time frame: Baseline and post-intervention (3 to 5 weeks)
Body Position Spatial Task (BPST) is a validated visuospatial memory task. The BPST incorporates spatial memory and navigational skills while maintaining posture. The examiner verbally and visually shows a series of side, forward, and turning steps, which the examinee repeats. If the examinee repeats the entire pattern correctly, they are scored as 1; any incorrect parts of the pattern result in a score of 0. Participants complete up to 8 different sequences and have up to 2 tries to perform the sequence correctly. Total scores can range from 0 to 8, with higher values indicating more sequences correctly performed and better.
Time frame: Baseline and post-intervention (3 to 5 weeks)
The number of sit-to-stand maneuvers completed in 30 seconds is used to measure leg strength and endurance. A higher score is better.
Time frame: Baseline and post-intervention (3 to 5 weeks)
The number of steps the participant takes to turn around in a complete circle. Lower number of steps is better.
Time frame: Baseline and post-intervention (3 to 5 weeks)
The time it takes the participants to turn around in a complete circle. Lower times are better.
Time frame: Baseline and post-intervention (3 to 5 weeks)
Measures the time it takes to rise from a chair, walk 3 meters, turn around, and return to the chair in the simple condition. In the Cognitive condition, one is required to simultaneously count backward by 3s from a number between 20 and 100; in the Manual condition, one is required to simultaneously pick up a cup of water and carry it while completing the task. A lower score is a better outcome.
Time frame: Baseline and post-intervention (3 to 5 weeks)
The SF12 evaluates the level of activity and perceived physical and mental quality of life.
The SF-12 uses a standardized system with scores ranging from 0 to 100, where the general population's average is 50, with higher scores indicating better health. Because it measures relative deviation, the numbers represent the following health levels:
Above 50: Better than average health. Exactly 50: Average health status. 40 to 50: Below average health (mild disability or impairment). 30 to 40: Moderate disability or impairment. Below 40: Severe impairment or disability.
Time frame: Baseline and post-intervention (3 to 5 weeks)
The Activities-specific Balance Confidence (ABC) Scale is a 16-item self-report questionnaire used to measure an individual's confidence in performing daily activities without losing their balance or feeling unsteady. Participants rate their self-confidence on a percentage scale from 0% (no confidence) to 100% (completely confident) for 16 specific tasks.
The total score is added for all 16 items and divided by 16 to get the average percentage score.
≥ 80%: Indicates a high level of physical functioning and balance confidence. 50% to 80%: Indicates a moderate level of physical functioning. < 50%: Indicates a low level of physical functioning.
Higher scores indicate a higher level of functioning and a lower risk of falling, while lower scores (below 67%) often indicate a higher risk of falling.
Time frame: Baseline and post-intervention (3 to 5 weeks)
The BDI-II is a 21-item self-report measure that taps major depression symptoms according to diagnostic criteria listed in the Diagnostic and Statistical Manual for Mental Disorders. Each item is scored 0-3, and clinicians sum all 21 scores to calculate a total between 0 and 63. Items are summed to create a total score, with lower scores indicating a lower level of depression and higher scores indicating higher levels of depression.
Total BDI-II scores are generally interpreted using these cutoff ranges:
0 to 13: Minimal depression
14 to 19: Mild depression
20 to 28: Moderate depression
29 to 63: Severe depression
Time frame: Baseline and post-intervention (3 to 5 weeks)
The PASE score combines information on leisure, household, and occupational activity. The PASE assesses the types of activities typically chosen by older adults (walking, recreational activities, exercise, housework, yard work, and caring for others. It uses frequency, duration, and intensity level of activity over the previous week to assign a score, ranging from 0 to 793, with higher scores indicating greater physical activity.
Time frame: Baseline and post-intervention (3 to 5 weeks)
The MSPSS has 12 items that assess how social support factors are perceived by individuals. This scale has three subscales to evaluate support by family, friends, and significant others. Respondents rate statements on a scale of 1 (very strongly disagree) to 7 (very strongly agree).
Total scores range from 12 to 84, with higher scores being better and indicating an increased perception of social support.
Time frame: Baseline and post-intervention (3 to 5 weeks)
The Patient Health Questionnaire (PHQ-9) is a 9-item, validated measure of depression severity in dementia. Respondents indicate how bothered by problems they are on a scale from 0 (not at all) to 3 (nearly every day). Total scores range from 0 to 27, where higher scores indicate more severe depression.
Scores fall into bands:
0 to 4 (none), 5 to 9 (mild), 10 to 14 (moderate), 15 to 19 (moderately severe), and 20 to 27 (severe)
Time frame: Baseline and post-intervention (3 to 5 weeks)
The CDR is designed to reflect the level of cognitive impairment based on a semi-structured interview with an informant and a separate mental status exam with the patient. The clinician rates each of the six general domains involving memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care.
A global rating is then generated, ranging from 0 = no impairment to 3 = severe impairment. Lower scores=better outcome.
0: Normal 0.5: Very Mild Dementia
Time frame: Baseline and post-intervention (3 to 5 weeks)
The 6-minute walk test (6MWT) assesses distance, in meters, walked over 6 minutes as a sub-maximal test of aerobic capacity and endurance. A higher score indicates a better outcome.
Normal range: A healthy adult typically walks between 400 m and 700 m in 6 minutes.
Impaired capacity: Walking less than 350 m to 300 m is associated with a poor prognosis and indicates significantly reduced functional capacity in conditions like chronic obstructive pulmonary disease (COPD) or heart failure.
Improvement: An increase in your distance by ≥ 30 m overtime typically indicates a positive response to treatment.
Time frame: Baseline and post-intervention (3 to 5 weeks)
Pulse wave activity (PWA) will be used to measure the arterial stiffness and will be measured using a SphygmoCor system before and after the intervention. A lower PWA(slower speed) indicates healthy, flexible arteries, whereas a higher PWA (faster speed) indicates stiff, less elastic arteries.
Time frame: Post-intervention (3 to 5 weeks)
Satisfaction will be assessed post-intervention only with an Exit Questionnaire with two focus groups, balanced for gender and race. Participants will rate (extremely easy/very easy) and their overall satisfaction with the intervention. A higher score indicates better satisfaction.
Time frame: Post-intervention (3 to 5 weeks)
Number of participants (Retention rate) retained in each group after enrollment throughout study participation.
Contact information is provided by the study sponsor or research team.
Emory University
Other
Moving Yourself in Space and Time Identifying Spatial and Temporal Components of Complex Rhythmic Movement Training for People With Parkinson's Disease and Cognitive Impairment
Acronym: MYSTIC
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