NCT07697664

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Mar 2022Dec 2028

Study Start

First participant enrolled

March 25, 2022

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

6.7 years

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

DanceMusicTherapyRehabilitationNeurodegenerativeParkinson'sAlzheimer'sMotor learningMotor control

Outcome Measures

Primary Outcomes (6)

  • 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.

    Baseline and post-intervention (3 to 5 weeks)

  • 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.

    Baseline and post-intervention (3 to 5 weeks)

  • 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.

    Baseline and post-intervention (3 to 5 weeks)

  • 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.

    Baseline and post-intervention (3 to 5 weeks)

  • 360 Turn Test (Steps)

    The number of steps the participant takes to turn around in a complete circle. Lower number of steps is better.

    Baseline and post-intervention (3 to 5 weeks)

  • 360 Turn Test (Time)

    The time it takes the participants to turn around in a complete circle. Lower times are better.

    Baseline and post-intervention (3 to 5 weeks)

Secondary Outcomes (3)

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

    Baseline and post-intervention (3 to 5 weeks)

  • Short Form 12-Quality of Life (SF12)

    Baseline and post-intervention (3 to 5 weeks)

  • Activities-specific Balance Confidence Scale (ABC)

    Baseline and post-intervention (3 to 5 weeks)

Other Outcomes (9)

  • Beck Depression Inventory II (BDI-II)

    Baseline and post-intervention (3 to 5 weeks)

  • Physical Activity Scale for the Elderly (PASE)

    Baseline and post-intervention (3 to 5 weeks)

  • Multidimensional Scale of Perceived Social Support (MSPSS) Score

    Baseline and post-intervention (3 to 5 weeks)

  • +6 more other outcomes

Study Arms (4)

Older adults with MCI

EXPERIMENTAL

Participants will attend daily (3-5 times/week) lessons that will last 1.5h for a month (e.g., 3-5 weeks) and will receive contact and monitoring from study staff. The Principal Investigator will monitor fidelity via weekly reports from interventionists.

Other: Complex Rhythmic Movement Sequences (CRMS) Sessions

Older adults without MCI

ACTIVE COMPARATOR

Participants will attend daily (3-5 times/week) lessons that will last 1.5h for a month (e.g., 3-5 weeks) and will receive contact and monitoring from study staff. The Principal Investigator will monitor fidelity via weekly reports from interventionists.

Other: Complex Rhythmic Movement Sequences (CRMS) Sessions

Older adults with PD

EXPERIMENTAL

Participants will attend daily (3-5 times/week) lessons that will last 1.5 h for a month (e.g., 3-5 weeks) and will receive contact and monitoring from study staff. The Principal Investigator will monitor fidelity via weekly reports from interventionists.

Other: Complex Rhythmic Movement Sequences (CRMS) Sessions

Young adults and adults with normal cognition (NC)

ACTIVE COMPARATOR

Participants will attend daily (3-5 times/week) lessons that will last 1.5h for a month (e.g., 3-5 weeks) and will receive contact and monitoring from study staff. The Principal Investigator will monitor fidelity via weekly reports from interventionists.

Other: Complex Rhythmic Movement Sequences (CRMS) Sessions

Interventions

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.

Also known as: Spatiotemporal activity modification (STEAM)
Older adults with MCIOlder adults with PDOlder adults without MCIYoung adults and adults with normal cognition (NC)

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 35 Years old
  • Montreal Cognitive Assessment (MoCA) score of 26 to 30
  • to 79 with or without MCI
  • to 79 years old with Parkinson's disease (PD), who do NOT have impaired decision-making capacity
  • Participants who achieve less than 150 minutes moderate or 75 minutes vigorous aerobic activity per week (as per the US Department of Health and Human Services (HHS)),

You may not qualify if:

  • Acute medical illness requiring hospitalization;
  • Uncontrolled congestive heart failure;
  • History of stroke in the past three years;
  • Inability to perform study procedures;
  • Medical or physical conditions that would preclude participation (e.g., severe arthritis or mobility problems, uncontrolled hypertension or diabetes, renal failure, history of angina with activity);
  • On medications that could adversely affect cognition, e.g., antipsychotics, opioids, stimulants, chemotherapy, and neurologic prescriptions to treat Multiple Sclerosis. When applicable, enrollment will be delayed until dosages are stable on e.g., Aricept, Namenda, anticholinesterase inhibitors, for at least 3 months
  • Psychotic disorders
  • Confounding neurologic conditions \[e.g., active central nervous system (CNS) opportunistic infections, seizure disorders, head injury with loss of consciousness \>30 minutes, intracranial neoplasms, stroke with neurological or neuropsychiatric sequelae\]
  • Substance Use Disorder, Major Depressive Disorder, and Generalized Anxiety Disorder within six months of evaluation.
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University, Executive Park, Wesley Woods

Atlanta, Georgia, 30329, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseAlzheimer Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDementiaTauopathiesNeurocognitive DisordersMental Disorders

Study Officials

  • Madeleine E. Hackney, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeleine E. Hackney, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Emory University School of Medicine

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start

March 25, 2022

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

July 13, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations