[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07551661":3,"trial-entities:NCT07551661":140,"trial-summary:NCT07551661":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":18,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":85,"minimum_age":86,"maximum_age":86,"healthy_volunteers":13,"eligibility_criteria":87,"std_ages":93,"locations":97,"central_contacts":116,"overall_officials":118,"references":119,"see_also_links":139},"NCT07551661","0126.32f-ETSU","Effects of an Independent Walking Program With Walking Poles in People With Parkinson Disease","RECRUITING","2027-01","2026-04","2026-04-27","East Tennessee State University","OTHER",false,"Study Purpose: The purpose of the study is to compare changes in walking in people with Parkinson disease after an 8-week independent walking program with or without using walking poles.\n\nMajor parts of the Study:\n\nBefore the walking program: Measurements will be taken of you while you are walking. You will be given tests and questionnaires about your movement and thinking. You will be trained on how to use walking poles.\n\nIndependent walking program: You will be asked to walk at least 3 times each week for 8 weeks and keep a log of your walking. If you are in the walking pole group, you will walk with the poles. After the walking program: Your walking, movement, and thinking measurements will be collected as before the walking program.\n\nFollow-up: The same measures of walking, movement, and thinking will be taken 3-months after ending the walking program.","Enrolled participants will complete the following Initial assessment\n\n* Participant demographics will be collected and include age, weight, height, foot length, gender, years since diagnosis, daily Parkinson medication, deep brain stimulation status, and the following questions: \"How many times have you fallen in the past 3 and 6 months?\", \"Are you comfortable using walking\u002Fhiking poles?\" and \"How many days per week do you participate in intentional exercise?\"\n* The Montreal Cognitive Assessment (MoCA) version 8.1 will be administered. If participant scores \\>18 (the cutoff score for mild cognitive impairment (MCI), they will continue in the study.\n* The MDS-UPDRS Part III and Trail Making Test Part A and B will be administered.\n* Outcome measures performed by walking on the GAITRite™ Walkway with Movella Xsens™ Bluetooth motion sensors (worn on upper back, lower back, arms, and legs) will include: 6-minute walk test (6 MWT), Timed-up-and go (TUG), TUG with a cognitive task, and the 10-meter walk test (10 MWT), and the Backward Walk Test. Heart rate will be collected with a Polar heart rate monitor chest strap during the 6-minute walk test.\n* Self-reported outcome measure will include: Activities Specific Balance Confidence Scale (ABC Scale), Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Patient Questionnaire (Part IB and II), the Revised Oswestry Disability Index, and the Freezing of Gait Questionnaire.\n* Participants will be trained on the use of walking poles, and then practice with the poles. The technique taught will be with the poles are held in front of the body, perpendicular to the ground, and swung in a reciprocal pattern. This initial training will last no more than 30 minutes and will include 10 minutes of independent pole practice.\n\nParticipants will return within a 14-day window for group or individual training walking with poles.\n\n* Outcome measures performed on the GAITRite™ Walkway prior to training will include: 10 MWT with and without poles.\n* Participant will train until they can demonstrate independent starting, \\>%50 correct technique and 100% self-correction within 3 missteps without cuing during 2 consecutive passes of 10 meters with a U-turn between passes.\n* Participants will then perform 10 minutes of independent poling practice.\n* Outcome measures performed on the GAITRite™ Walkway after training will include: 10 MWT with and without poles.\n* After training and the gait assessment data are collected, the study group allocation will be revealed to each participant by a study member not involved in the assessment data collection.\n* Participants randomized into the walking pole group will be provided with the poles for home use and asked to use the poles during all intentional walking for exercise during the study period. Pole use will not be restricted outside of the walking program.\n\nThe participants will participate in an independent walking program period for 8-weeks.\n\n* All participants (intervention and control) will be asked to participate in at least 3 days of intentional walking exercise for the subsequent 8 weeks. Each participant will be given a log (see attached) to record their walking frequency and duration, rating of perceived exertion (RPE), notes, and any adverse events. Participants will be educated on the RPE scale and provided with a laminated RPE scale (see attached). All participants will be instructed to contact a designated study member via phone or email as soon as possible if an adverse event occurs. Events are defined as \"Illness, injury, or falls\" and contact information is provided on each page of the log.\n* Participants will be contacted by a study member (see Check-in Script) by email (preferred) or phone (if participant does not use email or does not respond to email within 48 hours) at the end of weeks 1, 2, 4 and 6.\n\nAt conclusion of the 8-week walking program participants will return for reassessment.\n\n* Walking logs will be collected.\n* The MoCA version 8.2, MDS-UPDRS Part III and Trail Making Test Part A and B will be administered.\n* Outcome measures performed by walking on the GAITRite™ Walkway with Movella Xsens™ Bluetooth motion sensors (worn on upper back, lower back, arms, and legs) will include: 6-minute walk test, Timed-up-and go (TUG), TUG with a cognitive task, and the 10-meter walk test with and without poles, and the Backward Walk Test. Heart rate will be collected with a Polar heart rate monitor chest strap during the 6-minute walk test.\n* Self-reported outcome measure will include: Activities Specific Balance Confidence Scale (ABC Scale) and Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Patient Questionnaire (Part IB and II), the Revised Oswestry Disability Index, and the Freezing of Gait Questionnaire\n* Participants in the control group will be provided a pair of walking poles for personal use.\n\nThree-months following walking-program conclusion\n\n* Self-reported outcome measure will include: Activities Specific Balance Confidence Scale (ABC Scale) and Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Patient Questionnaire (Part IB and II), the Revised Oswestry Disability Index, and the Freezing of Gait Questionnaire\n* The MoCA version 8.3, MDS-UPDRS Part III and Trail Making Test Part A and B will be administered.\n* Outcome measures performed by walking on the GAITRite™ Walkway with Movella Xsens™ Bluetooth motion sensors (worn on upper back, lower back, arms, and legs) will include: 6-minute walk test, Timed-up-and go (TUG), TUG with a cognitive task, and the 10-meter walk test with and without poles, and the Backward Walk Test. Heart rate will be collected with a Polar heart rate monitor chest strap during the 6-minute walk test.\n* Participants will answer questions:\n* \"How many times have you fallen in the past 3 months?\"\n* \"How often in the past month do you intentionally walk for exercise?\"\n* \"What percentage in the past month do you use poles when intentionally walking for exercise?\"\n* \"Please share any thoughts you would like the study team to know about your experience using walking poles.\"",[17],"PARKINSON DISEASE (Disorder)",[19,20,21,22,23,24],"walking","physical activity","gait","Nordic walking","arm swing","walking poles","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},40,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Independent walking program using walking poles","Participants will independently walk at least 3 times a week for 8 weeks using walking poles",[38],"Walking Poles",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Independent walking program without walking poles","Participants will independently walk at least 3 times a week for 8 weeks without walking poles",[43],"No Walking Poles",[45],{"measure":46,"description":47,"timeFrame":48},"Six Minute Walk Test","Measurement of distance walked in 6 minutes, a reflection of functional capacity.","Prior to initiation of 8 week walking program, immediately upon completion, and 3 months after completion.",[50,54,57,60,63,66,69,72,75,78,82],{"measure":51,"description":52,"timeFrame":53},"Gait Characteristic - gait speed","Measure with a timed 10-meter walk test.","Prior to initiation of 8 week walking program, immediately upon completion, and 3-months after completion.",{"measure":55,"description":56,"timeFrame":48},"Backward Walk Test","Timed 5-meter backward walking to gather backward gait speed.",{"measure":58,"description":59,"timeFrame":48},"Timed Up and Go","The Timed Up and Go (TUG) is a standardized measure of functional mobility, balance, and fall risk in adults. It captures how efficiently a person can transition between sitting, standing, walking, turning, and sitting again.",{"measure":61,"description":62,"timeFrame":53},"Cognitive Timed Up and Go","The Cognitive Timed Up and Go (TUG) is a standardized measure of functional mobility, balance, and fall risk in adults. It captures how efficiently a person can transition between sitting, standing, walking, turning, and sitting again while performing a cognitive task of counting backward by 3.",{"measure":64,"description":65,"timeFrame":48},"Montreal Cognitive Assessment","The MoCA is a brief cognitive screening tool designed to detect mild cognitive impairment (MCI) and early cognitive decline.",{"measure":67,"description":68,"timeFrame":48},"The MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)","The MDS-UPDRS is a clinical rating scale used to evaluate motor and non-motor symptoms in Parkinson's disease. We will be completing parts 1B, 2, and 3, which focus on patient-reported daily experiences and clinician-rated motor performance.",{"measure":70,"description":71,"timeFrame":48},"Activity-specific Balance Confidence Scale","Self-administered questionnaire that reflects the participant's confidence in their ability to maintain their balance while performing the 16 listed tasks. Score ranges from 0-100% and reflects overall % confidence. Lower scores indicate less confidence and thus worse outcome",{"measure":73,"description":74,"timeFrame":48},"Arm swing","Arm swing data collected via inertial measurement unit (IMU) sensors on arms to measure angle and excursion; collected concurrently with 6MWT gait data.",{"measure":76,"description":77,"timeFrame":48},"Descriptive Gait Characteristics","Gait characteristics collected on gait walkway and via inertial measurement unit (IMU) sensors during gait tests, to include step length, step symmetry, and gait variability.",{"measure":79,"description":80,"timeFrame":81},"Freezing of Gait Questionnaire","A patient-reported measure that quantifies the severity, frequency, and functional impact of freezing of gait in people with Parkinson disease.","Prior to initiation of 8 week walking program, immediately upon completion, and 3-months after the completion.",{"measure":83,"description":84,"timeFrame":81},"Revised Oswestry Disability Index","A self-report questionnaire that measures how low back pain affects functional ability in everyday life.","ALL",null,{"inclusion":88,"exclusion":90,"raw_text":92},[89],"English-speaking, diagnosis of Parkinson disease, ability to walk safely and independently with or without a cane, and medically cleared to participate in an independent walking program. Participants must be physically present in the USA at the time of assessment.",[91],"diagnosis of any neurological disease other than PD (including but not limited to stroke, dementia, and multiple sclerosis; mild cognitive impairment is not excluded), regular (\\>30%) use of walking poles during walking for exercise for the prior 6 months, weight of more than 320 pounds or height more than 6'4\", unable to participate in walking for more than 7 consecutive days during the study period (ie, traveling, scheduled surgery), anticipated change in Parkinson-specific medication (including additions, removals, or changes in dosage) during the intervention period, a change in deep brain stimulation (DBS) parameters during the intervention.","Inclusion Criteria:\n\n* English-speaking, diagnosis of Parkinson disease, ability to walk safely and independently with or without a cane, and medically cleared to participate in an independent walking program. Participants must be physically present in the USA at the time of assessment.\n\nExclusion Criteria:\n\n* diagnosis of any neurological disease other than PD (including but not limited to stroke, dementia, and multiple sclerosis; mild cognitive impairment is not excluded), regular (\\>30%) use of walking poles during walking for exercise for the prior 6 months, weight of more than 320 pounds or height more than 6'4\", unable to participate in walking for more than 7 consecutive days during the study period (ie, traveling, scheduled surgery), anticipated change in Parkinson-specific medication (including additions, removals, or changes in dosage) during the intervention period, a change in deep brain stimulation (DBS) parameters during the intervention.",[94,95,96],"CHILD","ADULT","OLDER_ADULT",[98],{"facility":11,"status":7,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":113},"Johnson City","Tennessee","37614","United States",[104,109,111],{"name":105,"role":106,"phone":107,"email":108},"Tiffany Salido, PT, DPT, PhD","CONTACT","423-439-8727","salido@etsu.edu",{"role":106,"phone":110,"email":108},"8284235390",{"name":105,"role":112},"PRINCIPAL_INVESTIGATOR",{"lat":114,"lon":115},36.31344,-82.35347,[117],{"name":105,"role":106,"phone":107,"email":108},[],[120,124,127,130,133,136],{"pmid":121,"type":122,"citation":123},"32708938","RESULT","Szefler-Derela J, Arkuszewski M, Knapik A, Wasiuk-Zowada D, Gorzkowska A, Krzystanek E. Effectiveness of 6-Week Nordic Walking Training on Functional Performance, Gait Quality, and Quality of Life in Parkinson's Disease. Medicina (Kaunas). 2020 Jul 17;56(7):356. doi: 10.3390\u002Fmedicina56070356.",{"pmid":125,"type":122,"citation":126},"35593147","Salse-Batan J, Sanchez-Lastra MA, Suarez-Iglesias D, Varela S, Ayan C. Effects of Nordic walking in people with Parkinson's disease: A systematic review and meta-analysis. Health Soc Care Community. 2022 Sep;30(5):e1505-e1520. doi: 10.1111\u002Fhsc.13842. Epub 2022 May 20.",{"pmid":128,"type":122,"citation":129},"21603199","Reuter I, Mehnert S, Leone P, Kaps M, Oechsner M, Engelhardt M. Effects of a flexibility and relaxation programme, walking, and nordic walking on Parkinson's disease. J Aging Res. 2011;2011:232473. doi: 10.4061\u002F2011\u002F232473. Epub 2011 Mar 30.",{"pmid":131,"type":122,"citation":132},"28694221","Cugusi L, Manca A, Dragone D, Deriu F, Solla P, Secci C, Monticone M, Mercuro G. Nordic Walking for the Management of People With Parkinson Disease: A Systematic Review. PM R. 2017 Nov;9(11):1157-1166. doi: 10.1016\u002Fj.pmrj.2017.06.021. Epub 2017 Jul 8.",{"pmid":134,"type":122,"citation":135},"29480222","Mantri S, Fullard ME, Duda JE, Morley JF. Physical Activity in Early Parkinson Disease. J Parkinsons Dis. 2018;8(1):107-111. doi: 10.3233\u002FJPD-171218.",{"pmid":137,"type":122,"citation":138},"34689319","Domingues VL, Pompeu JE, de Freitas TB, Polese J, Torriani-Pasin C. Physical activity level is associated with gait performance and five times sit-to-stand in Parkinson's disease individuals. Acta Neurol Belg. 2022 Feb;122(1):191-196. doi: 10.1007\u002Fs13760-021-01824-w. Epub 2021 Oct 23.",[],{"nct_id":4,"conditions":141,"biomarkers":143},[142],"Parkinson Disease",[],{"nct_id":4,"found":145,"summary":146,"prompt_version":156},true,{"design":147,"status":148,"heading":149,"summary":150,"follow_up":151,"word_count":152,"commitments":153,"compensation":154,"drugs_mentioned":155},"This is an interventional study with a planned enrollment of 40 participants. It compares two groups: one using walking poles and one not using walking poles.","completed","Independent Walking Program with Walking Poles for Parkinson Disease","This study is looking at how an 8-week independent walking program affects people with Parkinson disease. Researchers want to compare walking with poles versus walking without poles. You would be asked to walk at least three times a week for eight weeks. Before and after the program, your walking will be measured, and you'll complete tests and questionnaires about your movement and thinking. The main goal is to see how much your walking improves, measured by a Six Minute Walk Test. To join, you need to speak English, have a Parkinson disease diagnosis, be able to walk safely on your own, and be medically cleared for an independent walking program. The study is currently unclear on its recruitment status.","Your walking, movement, and thinking will be measured immediately after the 8-week program and again 3 months after the program ends.",119,"You will have an initial assessment, then walk at least 3 times a week for 8 weeks, keeping a log. After the walking program, you will have follow-up assessments.","Not stated in the trial record.",[],"v2"]