[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07661524":3,"trial-entities:NCT07661524":108,"trial-summary:NCT07661524":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":43,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":15,"eligibility_criteria":58,"std_ages":71,"locations":74,"central_contacts":97,"overall_officials":100,"references":102,"see_also_links":107},"NCT07661524","IRB-300016813","Passive Versus Active Music Therapy Parkinson's Disease","Effects of Active Versus Passive Music Therapy on Functional Ability and Psychophysiological Responses to Goal-Directed Exercise in People With Parkinson's Disease","NOT_YET_RECRUITING","2027-08","2026-06","2026-06-22","2026-08","University of Alabama at Birmingham","OTHER",false,"The purpose of this pilot study is to identify the effects of active versus passive music therapy on functional ability and psychophysiological responses to goal-directed exercise in people with Parkinson's disease.","Using a crossover counterbalanced approach, participants with idiopathic PD (n=28) will be recruited to complete 3 separate experimental visits each with a differing condition: 1) No music (control; CON), 2) PMT, 3) AMT. For each condition, participants will complete a battery of functional testing (sit-to-stand test; STS) and goal-based exercise (6-minute walk test; 6MWT) separated by 20-minutes of rest. Functional ability will be determined via biomechanical parameters (i.e. peak force, braking force, rate of force development) during the 5-time STS test. Exercise capacity (i.e. distance, average walking velocity) will be determined for goal-based exercise during the 6MWT. During each test, a medical grade smartwatch will record psychophysiological (i.e. heart rate, metabolic equivalents, electrodermal activity) responses. Furthermore, psychometric testing for motivation, enjoyment, psychological arousal, fatigue, and rating of perceived exertion will be conducted after each test attempt.",[19],"Parkinson Disease (PD)",[21,22,23,24,25],"Music therapy","Exercise","Motivation","Parkinson's","Neurodegeneration","INTERVENTIONAL","TREATMENT",[29],"NA",{"count":31,"type":32},28,"ESTIMATED",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Passive music therapy","Listening to self-selected music",[36],{"type":35,"name":40,"description":41,"armGroupLabels":42},"Active music therapy","Structured music therapy with a licensed music therapist",[40],[44,48,51],{"measure":45,"description":46,"timeFrame":47},"Average time sit to stand","Time to complete 5 sit to stand test","Week 1, Week 2",{"measure":49,"description":50,"timeFrame":47},"Total walking distance accumulated in 6 minutes","Total distance in meters accumulated during a six minute walk test",{"measure":52,"description":53,"timeFrame":47},"Total motivation level","Motivation levels as assessed by a visual analog scale on 0 to 100 where 0 equals the absence of motivation and 100 indicates extremely motivated",[],"ALL","50 Years","89 Years",{"inclusion":59,"exclusion":66,"raw_text":70},[60,61,62,63,64,65],"Formal diagnosis of idiopathic PD","Hoen \\& Yahr Stage \\\u003CIII","Middle or old age onset of PD (at least 50 years of age)","The ability to ambulate without assistive devices","Stable medication regimen for four weeks prior to participation","No changes to treatment of PD in the last month.",[67,68,69],"Primary psychiatric disease (non-PD related)","Reports of falling in the last six weeks","Any reason a participant or their healthcare team believed their participation in the study could negatively impact their well-being.","Inclusion Criteria:\n\n* Formal diagnosis of idiopathic PD\n* Hoen \\& Yahr Stage \\\u003CIII\n* Middle or old age onset of PD (at least 50 years of age)\n* The ability to ambulate without assistive devices\n* Stable medication regimen for four weeks prior to participation\n* No changes to treatment of PD in the last month.\n\nExclusion Criteria:\n\n* Primary psychiatric disease (non-PD related)\n* Reports of falling in the last six weeks\n* Any reason a participant or their healthcare team believed their participation in the study could negatively impact their well-being.",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":94},"Birmingham","Alabama","35294","United States",[81,86,87,89,92],{"name":82,"role":83,"phone":84,"email":85},"Christopher G Ballmann, PhD","CONTACT","2059750613","cgb0002@uab.edu",{"role":83,"email":85},{"name":82,"role":88},"PRINCIPAL_INVESTIGATOR",{"name":90,"role":91},"Jane Allendorfer, PhD","SUB_INVESTIGATOR",{"name":93,"role":91},"Alexandra Evancho, DPT",{"lat":95,"lon":96},33.52066,-86.80249,[98],{"name":82,"role":83,"phone":99,"email":85},"205-975-0613",[101],{"name":82,"affiliation":13,"role":88},[103],{"pmid":104,"type":105,"citation":106},"42058676","BACKGROUND","Porrill SL, Allendorfer JB, Evancho AM, Ferguson CC, LaChenaye JM, Nguyen HM, Rogers RR, Ballmann CG. Effects of self-selected music on psychophysiological responses to goal-directed exercise in Parkinson's disease. Front Rehabil Sci. 2026 Apr 14;7:1778451. doi: 10.3389\u002Ffresc.2026.1778451. eCollection 2026.",[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Parkinson Disease",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an interventional study with a planned enrollment of 28 participants. It uses a crossover design, meaning you will experience all study conditions.","completed","Music Therapy for Parkinson's Disease","This study is looking at how different types of music therapy affect people with Parkinson's disease (PD). Researchers want to see if listening to self-selected music (passive music therapy) or working with a licensed music therapist (active music therapy) can improve your ability to move and your motivation during exercise. They will measure how long it takes you to stand up from a chair and how far you can walk in six minutes. You may be able to join if you are between 50 and 89 years old, have a formal diagnosis of PD, and can walk without help. The study aims to enroll 28 participants, but its current recruitment status is unclear.","Your functional ability and motivation levels will be measured at Week 1 and Week 2.",113,"You will complete three separate experimental visits, each involving functional tests (sit-to-stand, 6-minute walk) and psychometric testing. These measurements will be taken at Week 1 and Week 2.","Not stated in the trial record.",[36,40],"v2"]