Trial Outcomes & Findings for Motor Training in PD (NCT NCT02457832)

NCT ID: NCT02457832

Last Updated: 2025-10-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

87 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-10-15

Participant Flow

Participant milestones

Participant milestones
Measure
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.
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.
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.
Training
STARTED
34
31
22
Training
COMPLETED
24
25
19
Training
NOT COMPLETED
10
6
3
One Month Washout
STARTED
24
25
19
One Month Washout
COMPLETED
24
24
18
One Month Washout
NOT COMPLETED
0
1
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
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.
Training
Lost to Follow-up
10
6
3
One Month Washout
Lost to Follow-up
0
1
1

Baseline Characteristics

Motor Training in PD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Internally Guided Training (IG)
n=34 Participants
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.
Externally Guided Training (EG)
n=31 Participants
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.
Behavioral Control (BC)
n=22 Participants
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.
Total
n=87 Participants
Total of all reporting groups
Age, Continuous
70.7 years
STANDARD_DEVIATION 7.0 • n=5 Participants
68.6 years
STANDARD_DEVIATION 8.5 • n=7 Participants
68.0 years
STANDARD_DEVIATION 9.5 • n=5 Participants
69.36 years
STANDARD_DEVIATION 8.29 • n=4 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
14 Participants
n=7 Participants
6 Participants
n=5 Participants
33 Participants
n=4 Participants
Sex: Female, Male
Male
21 Participants
n=5 Participants
17 Participants
n=7 Participants
16 Participants
n=5 Participants
54 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
34 Participants
n=5 Participants
30 Participants
n=7 Participants
22 Participants
n=5 Participants
86 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=5 Participants
6 Participants
n=7 Participants
4 Participants
n=5 Participants
16 Participants
n=4 Participants
Race (NIH/OMB)
White
26 Participants
n=5 Participants
22 Participants
n=7 Participants
16 Participants
n=5 Participants
64 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
4 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Internal Guidance Training (IG)
n=19 Participants
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.
Externally Guided Training (EG)
n=19 Participants
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.
Behavioral Control (BC)
n=17 Participants
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.
Percent Signal Change
0 percentage of baseline BOLD signal
Standard Deviation 0
23 percentage of baseline BOLD signal
Standard Deviation 68
35 percentage of baseline BOLD signal
Standard Deviation 44

PRIMARY outcome

Timeframe: 12 weeks

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

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.

Outcome measures

Outcome measures
Measure
Internal Guidance Training (IG)
n=20 Participants
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.
Externally Guided Training (EG)
n=21 Participants
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.
Behavioral Control (BC)
n=17 Participants
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.
Connectivity Strength
-0.04 correlation coefficient
Standard Deviation 0.51
-0.03 correlation coefficient
Standard Deviation 0.43
0.14 correlation coefficient
Standard Deviation 0.34

Adverse Events

Internal Guidance Training (IG)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Externally Guided Training (EG)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Behavioral Control (BC)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Madeleine E. Hackney, Ph.D.

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

Phone: 404-315-4100

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place