Skip to content

Motor Training in PD

Optimizing Motor Training in Parkinson Disease Through Neural Mechanisms (NEURODEGEN)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02457832
Enrollment
87
Registered
2015-05-29
Start date
2015-06-01
Completion date
2023-12-31
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Magnetic Resonance Imaging, Neurology, Neurosciences, Physical Medicine, Parkinson Disease, Rehabilitation

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.

Detailed description

Persons with Parkinson's disease (PD) have impaired mobility, which adversely affects their quality of life. The effectiveness of adapted tango dance, in which participants both lead (internally guide: IG) and follow (externally guide: EG) movement has been shown. To improve outcomes in those with PD, the underlying brain mechanisms for both motor impairments and improvement must be studied. IG and EG movements have distinct brain activity patterns. Individuals with PD have trouble with IG movement but this problem is helped by strategies used while leading. During following, participants with PD can use many external cues, which helps movement in PD, because EG tasks bypass the basal ganglia, the part of the brain affected by PD. In older persons with PD, the investigators aim to: * determine brain activation patterns during IG and EG foot movement. * look into effects of IG and EG training on brain activation along with mobility improvements. The investigators will begin with a functional Magnetic Resonance Imaging test in a scanner. The investigators will look at brain area correlates of a clinically-used foot-tapping task, during IG and EG conditions in older persons with and without PD. Then, the investigators will assess the relative effectiveness of IG versus EG training during an adapted tango class, compared to a group that participates in health education, for improved mobility and foot tapping. Participants with PD will be assessed for disease severity. They will receive tests of outcome measures while OFF and ON PD-specific medications at the following time points: * 1 week before training * 1 week after training * 1 month after training Participants must attend 20 lessons of IG or EG adapted tango in 12 weeks, taught by an experienced instructor. In the functional MRI (fMRI) scanner, the investigators will assess participants for improved foot tapping after training. The investigators will also look at changes in activation in specific brain circuits along with training effects upon mobility. The long-term goal is to improve motor training as much as possible for persons with PD by understanding foot movement brain circuitry in PD as well as brain changes in circuitry through which training is effective. This work proposes to illumine information about brain function that is very important to continued progress in rehabilitative care of persons with PD.

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.

BEHAVIORALBehavioral Control (BC) Condition

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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Percent Signal Change12 weeksPercentage 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.
Connectivity Strength12 weeksChanges 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Internally Guided Training (IG)
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. Adapted Tango Dancing: 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.
34
Externally Guided Training (EG)
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. Adapted Tango Dancing: 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.
31
Behavioral Control (BC)
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 Control (BC) Condition: 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.
22
Total87

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
One Month WashoutLost to Follow-up011
TrainingLost to Follow-up1063

Baseline characteristics

CharacteristicInternally Guided Training (IG)Externally Guided Training (EG)Behavioral Control (BC)Total
Age, Continuous70.7 years
STANDARD_DEVIATION 7
68.6 years
STANDARD_DEVIATION 8.5
68.0 years
STANDARD_DEVIATION 9.5
69.36 years
STANDARD_DEVIATION 8.29
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants1 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
34 Participants30 Participants22 Participants86 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
6 Participants6 Participants4 Participants16 Participants
Race (NIH/OMB)
More than one race
2 Participants1 Participants1 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
26 Participants22 Participants16 Participants64 Participants
Sex: Female, Male
Female
13 Participants14 Participants6 Participants33 Participants
Sex: Female, Male
Male
21 Participants17 Participants16 Participants54 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 310 / 22
other
Total, other adverse events
0 / 340 / 310 / 22
serious
Total, serious adverse events
0 / 340 / 310 / 22

Outcome results

Primary

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.

Time frame: 12 weeks

Population: Sample size reflects study attrition and inability to tolerate fMRI scanning

ArmMeasureValue (MEAN)Dispersion
Internal Guidance Training (IG)Connectivity Strength-0.04 correlation coefficientStandard Deviation 0.51
Externally Guided Training (EG)Connectivity Strength-0.03 correlation coefficientStandard Deviation 0.43
Behavioral Control (BC)Connectivity Strength0.14 correlation coefficientStandard Deviation 0.34
Primary

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.

Time frame: 12 weeks

Population: The number of patients included in analyses is smaller than the total number of study participants due to study attrition and inability to tolerate the scanner.

ArmMeasureValue (MEAN)Dispersion
Internal Guidance Training (IG)Percent Signal Change0 percentage of baseline BOLD signalStandard Deviation 0
Externally Guided Training (EG)Percent Signal Change23 percentage of baseline BOLD signalStandard Deviation 68
Behavioral Control (BC)Percent Signal Change35 percentage of baseline BOLD signalStandard Deviation 44

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026