Moving Yourself in Space and Time: MYSTIC

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 to 35 Years old

Montreal Cognitive Assessment (MoCA) score of 26 to 30

50 to 79 with or without MCI

50 to 79 years old with Parkinson's disease (PD), who do NOT have impaired decision-making capacity

Disqualifiers

Acute medical illness requiring hospitalization;

Uncontrolled congestive heart failure;

History of stroke in the past three years;

Inability to perform study procedures;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Complex Rhythmic Movement Sequences (CRMS) Sessions

    Other intervention

    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: 1. practicing previously learned steps 2. 25-minute warmup, partnering/rhythmic exercises 3. learning new steps 4. combining old and new steps 5. cool down 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.

Treatment groups

210 Participants
are divided into 4 treatment groups
Group A: Older adults with MCIExperimental treatment 1 intervention
Group B: Older adults without MCIActive comparator 1 intervention
Group C: Older adults with PDExperimental treatment 1 intervention
Group D: Young adults and adults with normal cognition (NC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Four-Square Step Test (FSST)

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)
2

Gait Speed

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)
3

Body Position Spatial Task (BPST)

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)
4

30-Second Sit-to-Stand test

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)

Secondary outcomes

1

Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual)

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)
2

Short Form 12-Quality of Life (SF12)

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)
3

Activities-specific Balance Confidence Scale (ABC)

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)

Other outcomes

1

Beck Depression Inventory II (BDI-II)

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)
2

Physical Activity Scale for the Elderly (PASE)

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)
3

Multidimensional Scale of Perceived Social Support (MSPSS) Score

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)
4

Patient Health Questionnaire (PHQ-9) Score

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)

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