Nctid:
NCT06615115
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010300", "term"=>"Parkinson Disease"}, {"id"=>"D000020233", "term"=>"Gait Disorders, Neurologic"}, {"id"=>"D000003072", "term"=>"Cognition Disorders"}, {"id"=>"D000060825", "term"=>"Cognitive Dysfunction"}], "ancestors"=>[{"id"=>"D000020734", "term"=>"Parkinsonian Disorders"}, {"id"=>"D000001480", "term"=>"Basal Ganglia Diseases"}, {"id"=>"D000001927", "term"=>"Brain Diseases"}, {"id"=>"D000002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D000009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000009069", "term"=>"Movement Disorders"}, {"id"=>"D000080874", "term"=>"Synucleinopathies"}, {"id"=>"D000019636", "term"=>"Neurodegenerative Diseases"}, {"id"=>"D000019965", "term"=>"Neurocognitive Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M29705", "name"=>"Cognitive Dysfunction", "asFound"=>"Cognitive Deficits", "relevance"=>"HIGH"}, {"id"=>"M13213", "name"=>"Parkinson Disease", "asFound"=>"Parkinson's Disease", "relevance"=>"HIGH"}, {"id"=>"M6301", "name"=>"Cognition Disorders", "asFound"=>"Cognitive Deficits", "relevance"=>"HIGH"}, {"id"=>"M22058", "name"=>"Gait Disorders, Neurologic", "asFound"=>"Gait, Festinating", "relevance"=>"HIGH"}, {"id"=>"M22494", "name"=>"Parkinsonian Disorders", "relevance"=>"LOW"}, {"id"=>"M25603", "name"=>"Ganglion Cysts", "relevance"=>"LOW"}, {"id"=>"M16358", "name"=>"Synovial Cyst", "relevance"=>"LOW"}, {"id"=>"M4774", "name"=>"Basal Ganglia Diseases", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12029", "name"=>"Movement Disorders", "relevance"=>"LOW"}, {"id"=>"M2217", "name"=>"Synucleinopathies", "relevance"=>"LOW"}, {"id"=>"M21558", "name"=>"Neurodegenerative Diseases", "relevance"=>"LOW"}, {"id"=>"M21836", "name"=>"Neurocognitive Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"], "maskingDescription"=>"The participant will do the evaluations but no info will be given about the randomization adn groups."}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Participants who meet the inclusion criteria will be randomized into external focus of attention, combined focus of attention, and control groups. The same exercise program will be administered to all three groups by the same physiotherapist. The exercise program will last for 6 weeks, with sessions held three times a week. Although the exercises will be the same, the instructions given to the patients will vary by group. Assessments will be repeated at the beginning of treatment and at the end of the 6th week by a blinded evaluator."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>48}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-10-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-12-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-04-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Likert Scale Questionnaire", "timeFrame"=>"baseline, six weeks after the baseline", "description"=>"Likert scale is a measurement tool that combines multiple Likert-type questions. It is defined as the creation of two or more Likert-type questions to address a single research problem, and using the average values of these questions during the analysis phase. The aim is to determine individuals' average attitudes on these topics based on the combined values of all questions. To determine the scope of the patient's treatment, 5 questions and a high score of 10 are evaluated. The highest score is 50, indicating that the person is satisfied with the treatment; as the score decreases, satisfaction with the treatment decreases."}], "primaryOutcomes"=>[{"measure"=>"Berg Balance Scale", "timeFrame"=>"baseline, six weeks after the baseline", "description"=>"This is a 14-item scale that measures the ability to maintain balance during dynamic tasks. It is rated on a scale of 0 to 4 points, with a maximum total score of 56. As the total score decreases, the risk of falling increases.\n\n0 to 20 points: Indicates that the individual is dependent on a wheelchair and has a 100% risk of falling. 21 to 40 points: Suggests that the individual has a moderate risk of falling and may be able to walk with assistance. 41 to 56 points: Indicates that the individual can ambulate independently with a low risk of falling."}, {"measure"=>"Time Up and Go Dual Task", "timeFrame"=>"baseline, six weeks after the baseline", "description"=>"The test assesses balance, walking, and functionality during activities. The TUG-Dual Task evaluates walking abilities and attention management by asking participants to solve a simple math problem or perform another cognitive task while walking. Patients will be assessed for functionality, walking speeds, and balance evaluations. If the duration lasts more than 12 seconds, there is a risk of falling."}], "secondaryOutcomes"=>[{"measure"=>"The Parkinson's Disease Questionnaire-39 (PDQ-39)", "timeFrame"=>"baseline, six weeks after the baseline", "description"=>"The PDQ-39 is a PD specific health status questionnaire comprising 39 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. Items are grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100¼more health problems)."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Parkinson Disease", "Cognitive Deficit in Attention", "Feedback, Psychological", "Gait, Festinating"]}, "descriptionModule"=>{"briefSummary"=>"Parkinson's disease is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increases their quality of life. Recently, various additional methods have been developed to increase the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention has been shown to facilitate motor function development, reduce postural instability, and improve dual-task walking by being easier to remember. In Parkinson's patients who experience freezing phenomena, internal focus of attention instructions enhance walking stability and movement control, thereby reducing the risk of falls. However, there are no studies on the combined focus of attention instructions in Parkinson's patients. This study is designed as a randomized controlled, single-blind, prospective trial to examine the effects of a combination of internal and external focus of attention instructions on walking, balance parameters, quality of life, and patient satisfaction levels, taking into account the presence of freezing phenomena in Parkinson's patients.", "detailedDescription"=>"Parkinson's disease (PD) is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Such deficits are associated with the acquisition of motor function skills. Although PD patients are open to learning, they experience challenges with motor planning. Therefore, individuals with PD may require additional training, sensory input, and motor education for the permanence and ease of motor skill acquisition.\n\nThe difficulties PD patients face with complex commands indicate that they can learn in a feedforward manner, but they show inconsistencies in the use of automatic functions. This inconsistency results in challenges in adapting to variable situations and performing complex activities (like balance and walking). Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increasing their quality of life. Recently, various additional methods have been developed to enhance the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. One commonly used method to address deficits in motor behavior is motor learning activities, which involve repetitive movements and ensure continuity.\n\nMany studies have shown that the concept of focus of attention contributes to the efficiency and learning of various motor functions, particularly balance. Individuals with Parkinson's are highly receptive to external stimuli, so a focus-based strategy during balance and walking training can improve these skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention facilitates motor function development, reduces postural instability, and improves dual-task walking. In Parkinson's patients who experience freezing phenomena, internal focus of attention instructions enhance walking stability and movement control, thereby reducing the risk of falls. However, there are no studies on the combined focus of attention instructions in Parkinson's patients.\n\nThis study is designed as a randomized controlled, single-blind, prospective trial to examine the effects of a combination of internal and external focus of attention instructions on walking, balance parameters, quality of life, and patient satisfaction levels, considering the presence of freezing phenomena in Parkinson's patients. Approximately 48 individuals with Parkinson's disease without freezing phenomena will participate in an exercise program for six weeks, three days a week. Participants will be randomized into a combined focus group, an external focus group, and a control group. Assessments will be repeated at the beginning and end of the six-week exercise program."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"50 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Hoehn and Yahr Stage II or III\n* Individuals between the ages of 50 and 70 who can walk independently but have balance disorders\n* Having a score between 21-56 on the Berg Balance Scale\n* Having a score between 24-30 on the Mini Mental State Test\n* Having agreed to participate in the study (Not having a freezing phenomenon)\n* Being in the Medication-on period\n\nExclusion Criteria:\n\n* Having malignancy and metabolic diseases\n* Having had Cerebrovascular Accident before\n* Other neurological disease history\n* Presence of cognitive problems\n* Presence of visual or hearing disorders\n* Presence of deep brain pacemaker\n* Presence of freezing phenomenon (persons with Freezing of Gait Questionnaire FOG-Q above zero)\n* Presence of dyskinesia"}, "identificationModule"=>{"nctId"=>"NCT06615115", "briefTitle"=>"The Effect of Different Types of Focus Instructions in Parkinson's Rehabilitation", "organization"=>{"class"=>"OTHER", "fullName"=>"Bahçeşehir University"}, "officialTitle"=>"Effects of an External and Combined Focus of Attention-Instructed Exercise Program on Postural Stability and Dual-Task Walking in Parkinson's Disease: A Randomized, Assessor-Blinded, Controlled Trial", "orgStudyIdInfo"=>{"id"=>"LPar24"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"External Attention Focus Instructions Group", "description"=>"All participants will perform a total body stretching exercise for 10 minutes, followed by 10 minutes of obstacle course navigation, 10 minutes of balance training (including tandem walking, balance board exercises, single-leg balance, and two-legged reaching exercises), and will conclude with 10 minutes of strength training exercises. Throughout these activities, the physiotherapist will guide the participants using only external focus of attention instructions.", "interventionNames"=>["Other: Exercise"]}, {"type"=>"EXPERIMENTAL", "label"=>"Combined Attention Focus Instructions", "description"=>"The exercise program given to the External Focus of Attention group will also be administered to this group. While guiding the exercises, the physiotherapist will use the combination of both external and internal focus of attention instructions to direct the participants.", "interventionNames"=>["Other: Exercise"]}, {"type"=>"EXPERIMENTAL", "label"=>"Control Group", "description"=>"The same exercise program given to the other groups will also be administered to this group but no instruction will be given to this group.", "interventionNames"=>["Other: Exercise"]}], "interventions"=>[{"name"=>"Exercise", "type"=>"OTHER", "description"=>"All participants will perform a total body stretching exercise for 10 minutes, followed by 10 minutes of obstacle course navigation, 10 minutes of balance training (including tandem walking, balance board exercises, single-leg balance, and two-legged reaching exercises), and will conclude with 10 minutes of strength training exercises.", "armGroupLabels"=>["Combined Attention Focus Instructions", "Control Group", "External Attention Focus Instructions Group"]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Pelin Pişirici, PT, PhD", "role"=>"CONTACT", "email"=>"pelinpisirici@gmail.com", "phone"=>"05055016076"}, {"name"=>"Selen Gür Özmen, MD", "role"=>"CONTACT", "email"=>"selen.gur.ozmen@bau.edu.tr", "phone"=>"05323941011"}], "overallOfficials"=>[{"name"=>"Leyla Koçak, PT", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Bahcesehir University, Faculty of Health Sciences, Department of Physiotherapy"}, {"name"=>"Pelin Pişirici, PT, PhD", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Bahcesehir University, Faculty of Health Sciences"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Bahçeşehir University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Assistant Professor, PT, PhD", "investigatorFullName"=>"Pelin Pişirici", "investigatorAffiliation"=>"Bahçeşehir University"}}}}
