NCT02457832

Brief Summary

The purpose of this research study is to learn more about brain activity when individuals with and without Parkinson disease (PD) move their lower limbs. The investigators also want to see if and how two different types of partnered dance affect brain activity in individuals with and without PD. Testing will take place at the Atlanta VA Medical Center and at Emory University. The investigators expect to enroll about 140 people for this study over a five-year period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 21, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 15, 2024

Completed
Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

7.6 years

First QC Date

May 21, 2015

Results QC Date

February 1, 2024

Last Update Submit

October 2, 2025

Conditions

Keywords

Magnetic Resonance ImagingNeurologyNeurosciencesPhysical MedicineParkinson DiseaseRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Percent Signal Change

    Percentage of baseline BOLD signal across activated brain regions. Activation values that remain significant after type-I error control in imaging software are averaged across brain regions, converted to Percent Signal Change, and presented as Mean (%) ± SD (%) across brain regions investigated.

    12 weeks

  • Connectivity Strength

    Changes in average connectivity strength across striatal-thalamo-cortical (STC) and cerebello-thalamo-cortical (CTC) circuits, as measured by average cross correlation coefficient between the seed regions of the circuits.

    12 weeks

Study Arms (4)

Internal guidance training (IG)

EXPERIMENTAL

Adapted tango dancing is a sophisticated, yet accessible system of tactile communication that conveys motor intentions and goals between a leader and follower. Those in IG training will choose direction, timing and amplitude of each successive step, and will communicate this information to their partner through moving their frame and center of mass.

Behavioral: Adapted Tango Dancing

Externally guided training (EG)

EXPERIMENTAL

Those in EG will learn to attend to sensory cues for movement direction, timing and amplitude of steps, communicated from their partner to them via the frame and center of mass. The 'follower' will wait to receive the movement cue before moving.

Behavioral: Adapted Tango Dancing

Behavioral Control (BC)

ACTIVE COMPARATOR

BC participants will attend group health education sessions adapted to the needs of individuals with PD, about pharmacological management, nutrition, sleep disorders, cognitive deficits, bereavement coping, mobility, balance and home safety. Participants in this training will be instructed not to change their habitual exercise routines. After completing health education, participants will be assigned to an IG or EG training class but will not undergo evaluations.

Behavioral: Behavioral Control (BC) Condition

Normal Control (NC)

NO INTERVENTION

Age-matched controls without Parkinson's disease will come in for a single assessment including MRI.

Interventions

Composed of simple steps, tango involves frequent movement initiation and cessation, multi-directional perturbations and varied rhythms. Participants focus on trunk control and stepping strategies, coordination, somatosensory awareness, attention to partner, path of movement, and aesthetics. Sessions will begin with a typical dance class warm-up consisting of breathing, limbering and postural alignment to upbeat music. Novel step elements will be introduced every class period. Those with PD will partner with an individual without PD. After novel step introduction, the instructor will present rhythmic training, which is indispensable to partnered dancing. Participants will learn 'typical' rhythms from tango and Latin dances, based upon the system of quicks (Q) and slows (S), ubiquitously used in ballroom dance training to understand the temporal relationship of movement to music.

Externally guided training (EG)Internal guidance training (IG)

Group health education sessions adapted to the needs of individuals with PD, about pharmacological management, nutrition, sleep disorders, cognitive deficits, bereavement coping, mobility, balance and home safety.

Behavioral Control (BC)

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 - 70 years
  • Willingness to spend 1-h in a scanner
  • Able to walk with or without an assistive device 10 feet
  • Best corrected/aided acuity better than 20/70 in the better eye
  • Absence of dementia or vascular cognitive impairment
  • Absence of primary memory deficits

You may not qualify if:

  • Deep brain stimulator implants, Metallic implants, fragments, or pacemakers
  • Montreal Cognitive Assessment (MocA) score \< 24
  • Pure-tone threshold sensitivity \> 40 dB
  • Peripheral neuropathy
  • Untreated Major Depression
  • History of stroke, or traumatic brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

Related Publications (3)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  • Prime M, McKay JL, Bay AA, Hart AR, Kim C, Abraham A, Hackney ME. Differentiating Parkinson Disease Subtypes Using Clinical Balance Measures. J Neurol Phys Ther. 2020 Jan;44(1):34-41. doi: 10.1097/NPT.0000000000000297.

MeSH Terms

Conditions

Parkinson Disease

Interventions

Behavior Control

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsBehavioral Disciplines and Activities

Results Point of Contact

Title
Madeleine E. Hackney, Ph.D.
Organization
Associate Professor of Medicine Emory University School of Medicine, Department of Medicine, Division of Geriatrics and Gerontology; Research Health Scientist Atlanta VA Health Care System, Center for Visual and Neurocognitive Rehabilitation

Study Officials

  • Madeleine E. Hackney, PhD

    Atlanta VA Medical and Rehab Center, Decatur, GA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2015

First Posted

May 29, 2015

Study Start

June 1, 2015

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

October 15, 2025

Results First Posted

August 15, 2024

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations