Parkinson DiseaseAPPROACHNCT07824128
Adaptango Performance PRocess for Older Adults Community reHabilitation
A study testing Adaptango Performance Process (APP) program in people with Parkinson Disease and Mild Cognitive Impairment, run by Emory University at 1 site in United States.
Trial summary
This study is being done to answer the question: How do people with Parkinson's disease, people with Mild Cognitive Impairment, and younger people process difficult topics in conversation? It will also explore themes related to dance, such as community building and justice, as perceived by persons with Parkinson's… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Mild Cognitive Impairment, Old Age; Dementia
- What is being tested?
- Adaptango Performance Process (APP) program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals (PWP, younger adults, PLwD) from the greater Atlanta area. Those in the PWP group must be diagnosed by a neurologist specialized in Parkinson's disease.
- Score of at least 18 on the Montreal Cognitive Assessment (MoCA). Those who are in the PLwD group must score between 18 and 25 on the MoCA.
Who cannot join
- 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)
- Taking medications that could adversely affect cognition, e.g., antipsychotics, opioids, stimulants, chemotherapy, 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
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- 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 Disorders within six months of evaluation
- Unable to provide informed consent
- Cognitively impaired individuals or individuals with impaired decision-making, individuals who are not yet adults, pregnant women, prisoners
- Not able to clearly understand English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Emory University, Executive Park, Wesley Woods
Atlanta, Georgia, 30329
About this study
Official title: Community-based Participatory Evaluation Studies on a Partnered Dance Program for Adults With Neurodegenerative Disease
This study is being done to answer the question: How do people with Parkinson's disease, people with Mild Cognitive Impairment, and younger people process difficult topics in conversation? It will also explore themes related to dance, such as community building and justice, as perceived by persons with Parkinson's disease or Mild Cognitive Impairment, and younger individuals before and after the Adaptango performance process.
Read the detailed description
This is a pilot study designed to assess the impact of the mediator/instructor role between dyads of older and younger adults as they engage in art and dance activities that address challenging topics.
The study aims to evaluate the effects of the Adaptango Performance Process (APP) on creativity, justice, and quality of life among persons with Parkinson's disease (PWP), people living with dementia (PLWD), and young adult participants. Validated measures of creativity, justice, and quality of life will be administered before and after the intervention.
The findings from this pilot phase will be used to inform the design and power calculations of future larger clinical trials intended to more definitively evaluate the effects of the APP program on creativity, engagement with challenging topics of societal importance, and psychosocial health across generations.
Findings from the arts-based method evaluation will also be considered when interpreting and reporting study results.
- Being tested
- Adaptango Performance Process (APP) program
- Keywords
- Dance, Music, Rehabilitation, Parkinson's, Motor-cognitive integration
- Medical subject headings
- Parkinson Disease, Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptango Performance Process (APP) programOther
Participants will take a three-month, biweekly choreographic process, ending in a weekend performance workshop at Emory University.
Tango instructors undergo 13 hours of American Council on Exercise-certified training on Adaptango methods, age-specific functional impairments, and fall detection and prevention. Adaptango modifications were made to the frame and several steps of Argentine tango.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults over 18 and less than 31 years | Experimental | Healthy adults over 18 and less than 31 years Receives: Other: Adaptango Performance Process (APP) program |
| Adults with Parkinson's disease (PD) age 50 years and over | Experimental | Adults with Parkinson's disease aged 50 years and over Receives: Other: Adaptango Performance Process (APP) program |
| Adults with mild cognitive impairment (MCI) age 50 years and over | Experimental | Adults with MCI aged 50 years and over Receives: Other: Adaptango Performance Process (APP) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' Satisfaction of the intervention (Acceptability)
Satisfaction will be assessed post-intervention only with an Exit Questionnaire balanced for gender and race. Participants will rate (extremely easy/very easy) and their overall satisfaction with the intervention. A higher score indicates better satisfaction.
Measured: Post-intervention at 8 months
Alternate Uses Task (AUT)
The Alternate Uses Task (AUT) will be used to assess the patient's creativity by asking them to come up with as many alternate uses for an everyday object as possible in two minutes. Results are measured across four subscales: fluency- the number of alternative uses thought of originality - how unusual the uses given are; flexibility - the range of ideas in different categories; and elaboration-the level of detail given to an idea. Higher values in each subscale indicate higher levels of creativity.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Secondary outcomes (14)
Parkinson's Disease Questionnaire Summary Index (PDQ-39 SI)
The PDQ-39 is a patient-reported, disease-specific questionnaire used to assess health status and quality of life in Parkinson's disease over the preceding month. It consists of 39 items grouped into 8 distinct dimensions: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items), and bodily discomfort (3 items). Each item is scored on a 5-point Likert scale indicating frequency: 0 (never), 1 (occasionally), 2 (sometimes), 3 (often), and 4 (always or cannot do at all).
The PDQ-39 Summary Index (PDQ-39 SI) is derived by calculating the mean of the 8 dimension scores.
Total index scores range from 0 to 100. Lower scores reflect a better health status/quality of life, while higher scores indicate a greater frequency and severity of health-related difficulties.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
The Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive 50-question clinical tool used to evaluate both motor and non-motor symptoms, severity, and progression of Parkinson's disease. Each item is scored from 0 (normal) to 4 (severe), with higher summed subscale scores indicating greater disability.
Will you be reporting a paticular part of the scale, or are you reporting all? If so, we will need to entere separate parts with their respective scorings
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
30-second chair 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.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
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.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
360 turn test (Time)
The time it takes the participants to turn around in a complete circle. Lower times are better.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
360 turn test (steps)
The number of steps the participant takes to turn around in a complete circle. Lower number of steps is better.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Static Postural Balance Assessment via Tandem Stance Test
Participants are instructed to stand with one foot directly in front of the other, heel-to-toe, with eyes open and arms at their sides or crossed over the chest. The examiner assists the participant into position and begins timing with a stopwatch once the examiner releases their hand support. Timing is recorded in seconds and ceases if the participant moves their feet, reaches for support, opens their eyes (if an eyes-closed variant), or reaches the ceiling threshold
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Mini-BESTest (Mini-Balance Evaluation Systems Test) is a validated, performance-based assessment used to evaluate balance, functional mobility, and fall risk. It includes 14 items across four domains, with each item scored from 0 to 2:
2 = Normal: Completes the task safely, quickly, and independently.
1 = Mild impairment: Completes the task with hesitation, slower movement, uneven weight shifts, or use of an assistive device.
0 = Severe impairment/Unable: Requires physical assistance or cannot complete the task safely.
Total Score Interpretation (0-28):
27-28: Normal balance; no significant deficits. 22-26: Mild balance impairment; monitoring or preventive exercise may be beneficial.
<22: Significant balance impairment, indicating increased balance dysfunction and fall risk.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
The Dynamic Gait Index (DGI)
DGI is an 8-item clinical assessment used to evaluate gait adaptability and balance during functional walking tasks. Each item is scored on a 4-point scale (0-3): 3 = normal performance; 2 = mild impairment; 1 = moderate impairment; 0 = severe impairment or inability to perform independently.
Total scores range from 0 to 24, with higher scores indicating better dynamic balance and mobility.
Scores of 22-24 indicate normal balance and safe ambulation; 19-21 indicate mild instability; scores <19 are associated with increased fall risk in older adults and individuals with neurological conditions.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Gait speed test
Gait speed testing (Forward/Backwards/Fast): How quickly a person can walk a specific distance forward and Backwards using a stopwatch. Faster speeds (m/s) are better.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Four-square step test
The Four Square Step Test (FSST) is a quick clinical tool used to measure dynamic balance, agility, and the risk of falls by having a person rapidly step over low obstacles-traditionally four canes arranged in a plus-sign configuration on the floor. Because the Four Square Step Test (FSST) is a timed test, it does not use a point-based scale. Instead, performance is measured solely by the number of seconds it takes to complete the pattern. Normal values for the Four Square Step Test (FSST) generally range from under 10 to 15 seconds for healthy adults. A completion time of under 15 seconds indicates a low risk for falls in older adults, while a time of 15 seconds or longer suggests an increased risk for multiple falls.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
The 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.
Measured: Baseline, 3 months (during APP ), and 8 months (after the APP program)
The 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.
Measured: Baseline, 3 months (during APP ), and 8 months (after the APP program)
The Impact on Participation and Autonomy Questionnaire (IPAQ).
The Impact on Participation and Autonomy (IPA) instrument will be used to assess the patient's self-perceived freedom and social involvement. Individual items are graded on a 0-4 scale. Subscale scores will be calculated for Autonomy Indoors (0-28), Autonomy Outdoors (0-20), Family Role (0-28), Social Relations (0-28), and Work/Education (0-24). Higher subscale totals directly reflect an increase in perceived limitations and restrictions of participation. A reduction in subscale values indicates a positive clinical response to treatment.
Measured: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Responsible party
- Principal investigator, Madeleine Eve Hackney, Emory University
- Investigators
- Madeleine E. Hackney, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824128
- Sponsor's protocol ID
- 2025P008930
- Other IDs
- 1925601-38-24
- Acronym
- APPROACH
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Participatory Evaluation Studies on a Partnered Dance Program for Adults With Neurodegenerative Disease
- ClinicalTrials.gov ID
- NCT07824128
- Acronym / sponsor ID
- APPROACH / 2025P008930
- Keywords
- Dance, Music, Rehabilitation, Parkinson's, Motor-cognitive integration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to answer the question: How do people with Parkinson's disease, people with Mild Cognitive Impairment, and younger people process difficult topics in conversation? It will also explore themes related to dance, such as community building and justice, as perceived by persons with Parkinson's disease or Mild Cognitive Impairment, and younger individuals before and after the Adaptango performance process.
Detailed description
This is a pilot study designed to assess the impact of the mediator/instructor role between dyads of older and younger adults as they engage in art and dance activities that address challenging topics.
The study aims to evaluate the effects of the Adaptango Performance Process (APP) on creativity, justice, and quality of life among persons with Parkinson's disease (PWP), people living with dementia (PLWD), and young adult participants. Validated measures of creativity, justice, and quality of life will be administered before and after the intervention.
The findings from this pilot phase will be used to inform the design and power calculations of future larger clinical trials intended to more definitively evaluate the effects of the APP program on creativity, engagement with challenging topics of societal importance, and psychosocial health across generations.
Findings from the arts-based method evaluation will also be considered when interpreting and reporting study results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy adults over 18 and less than 31 years | Experimental | Other: Adaptango Performance Process (APP) programHealthy adults over 18 and less than 31 years |
| Adults with Parkinson's disease (PD) age 50 years and over | Experimental | Other: Adaptango Performance Process (APP) programAdults with Parkinson's disease aged 50 years and over |
| Adults with mild cognitive impairment (MCI) age 50 years and over | Experimental | Other: Adaptango Performance Process (APP) programAdults with MCI aged 50 years and over |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals (PWP, younger adults, PLwD) from the greater Atlanta area. Those in the PWP group must be diagnosed by a neurologist specialized in Parkinson's disease.
- Score of at least 18 on the Montreal Cognitive Assessment (MoCA). Those who are in the PLwD group must score between 18 and 25 on the MoCA.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptango Performance Process (APP) programParticipants will take a three-month, biweekly choreographic process, ending in a weekend performance workshop at Emory University. Tango instructors undergo 13 hours of American Council on Exercise-certified training on Adaptango methods, age-specific functional impairments, and fall detection and prevention. Adaptango modifications were made to the frame and several steps of Argentine tango. | Other | Adults with Parkinson's disease (PD) age 50 years and over, Adults with mild cognitive impairment (MCI) age 50 years and over, Healthy adults over 18 and less than 31 years |
Primary outcome
Participants' Satisfaction of the intervention (Acceptability)
Time frame: Post-intervention at 8 months
Satisfaction will be assessed post-intervention only with an Exit Questionnaire balanced for gender and race. Participants will rate (extremely easy/very easy) and their overall satisfaction with the intervention. A higher score indicates better satisfaction.
Alternate Uses Task (AUT)
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
The Alternate Uses Task (AUT) will be used to assess the patient's creativity by asking them to come up with as many alternate uses for an everyday object as possible in two minutes. Results are measured across four subscales: fluency- the number of alternative uses thought of originality - how unusual the uses given are; flexibility - the range of ideas in different categories; and elaboration-the level of detail given to an idea. Higher values in each subscale indicate higher levels of creativity.
14 secondary outcomes
Parkinson's Disease Questionnaire Summary Index (PDQ-39 SI)
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
The Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
30-second chair stand test
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Timed Up and Go Simple and Dual tasks (TUG, TUG Cognitive and TUG Manual)
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
360 turn test (Time)
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
360 turn test (steps)
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Static Postural Balance Assessment via Tandem Stance Test
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
The Dynamic Gait Index (DGI)
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Gait speed test
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Four-square step test
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
The Multidimensional Scale of Perceived Social Support (MSPSS) Score
Time frame: Baseline, 3 months (during APP ), and 8 months (after the APP program)
The Short Form 12-Quality of Life (SF12)
Time frame: Baseline, 3 months (during APP ), and 8 months (after the APP program)
The Impact on Participation and Autonomy Questionnaire (IPAQ).
Time frame: Baseline, 3 months (during intervention), and 8 months (post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Madeleine E. Hackney, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptango Performance Process (APP) program in people with Parkinson Disease and Mild Cognitive Impairment, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeleine E. Hackney, PhD (314-412-4852, mehackn@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' Satisfaction of the intervention (Acceptability) (time frame: Post-intervention at 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.