Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-02-05 @ 6:43 PM
Study NCT ID:
NCT06482502
Status:
RECRUITING
Last Update Posted:
2025-03-07
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of the 6-Minute Pegboard and Ring Test in Parkinson's Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-06', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6-Minute Pegboard and Ring Test', 'timeFrame': 'Baseline of the study (Assessor 1)', 'description': 'The patient is in a sitting position. Opposite the patient are 4 metal rods located on a wooden table. Two of them are at shoulder level and the other two are 20 cm above shoulder level. During the test, the patient is asked to take the light rings at shoulder level with both hands at the same time and place them on the bars above. The higher the total number of rings carried indicates increased endurance.'}, {'measure': '6-Minute Pegboard and Ring Test', 'timeFrame': '2 days after the baseline assessment (Assessor 1)', 'description': 'The patient is in a sitting position. Opposite the patient are 4 metal rods located on a wooden table. Two of them are at shoulder level and the other two are 20 cm above shoulder level. During the test, the patient is asked to take the light rings at shoulder level with both hands at the same time and place them on the bars above. The higher the total number of rings carried indicates increased endurance.'}, {'measure': '6-Minute Pegboard and Ring Test', 'timeFrame': 'Baseline of the study (Assessor 2)', 'description': 'The patient is in a sitting position. Opposite the patient are 4 metal rods located on a wooden table. Two of them are at shoulder level and the other two are 20 cm above shoulder level. During the test, the patient is asked to take the light rings at shoulder level with both hands at the same time and place them on the bars above. The higher the total number of rings carried indicates increased endurance.'}, {'measure': '6-Minute Pegboard and Ring Test', 'timeFrame': '2 days after the baseline assessment (Assessor 2)', 'description': 'The patient is in a sitting position. Opposite the patient are 4 metal rods located on a wooden table. Two of them are at shoulder level and the other two are 20 cm above shoulder level. During the test, the patient is asked to take the light rings at shoulder level with both hands at the same time and place them on the bars above. The higher the total number of rings carried indicates increased endurance.'}, {'measure': '30-Second Arm Curl Test', 'timeFrame': 'Baseline of the study', 'description': 'This test is performed with dumbbells. A 2.5-kilogram (5-pound) dumbbell is used for women and a 4-kilogram (8-pound) dumbbell for men. The test is performed in a sitting position. Patients are asked to repeat forearm flexion-supination and extension-pronation movements with the dumbbells in their hands as fast as they can for 30 seconds. The number of moves completed gives the total score.'}, {'measure': 'Weight Lifting Test', 'timeFrame': 'Baseline of the study (Assessor 2)', 'description': 'This test is performed using dumbbells. Reference weights for women are 7 kg and for men are 10 kg. Patients will perform the test with each arm separately. The number of repetitions they can achieve is recorded. The test is performed standing.'}], 'secondaryOutcomes': [{'measure': 'Demographic Data Form', 'timeFrame': 'Baseline of the study', 'description': "This form was created by researchers and it consist of personal informations such as gender, age, body mass index, education, duration of disease, Unified Parkinson's Disease Rating Scale, Modified Hoehn \\& Yahr stage, using medicine, manual shoulder muscle strength"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson', 'Validity', '6-Minute Pegboard and Ring Test'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'Tests used to assess upper extremity endurance in Parkinson\\'s patients are limited. This study aimed to investigate whether the 6-Minute Pegboard and Ring Test (6-MPRT), which has been validated in many respiratory disease groups in previous studies, is an endurance assessment battery that can also be used in Parkinson\\'s patients. 6-MPRT, Weight Lifting Test, and 30-Second Arm Curl Test will be applied in the assessments. Assessments will be made twice on the same day by two different evaluators, 1 hour apart. After the first evaluation, the patient will be called for the second time 2 days later, and the same procedure will be repeated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Parkinson Disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hoehn \\& Yahr staging ≤3 points,\n* Individuals who have not undergone a rehabilitation program of at least 20 days in the last 6 months,\n* Those with full upper extremity shoulder flexion and abduction active joint range of motion.\n\nExclusion Criteria:\n\n* Those with severe heart disease such as heart failure, cardiac arrhythmia, hypertension,\n* People with any orthopedic problem that will affect the upper extremity,\n* Having a secondary neurological disease diagnosis,\n* Having vision impairment that may affect measurement methods (not corrected by glasses),\n* Having a cognitive disease that may cause difficulty in following the researchers\\' commands,\n* Those who had changes in their medical use during the test (dose increase/decrease, drug change'}, 'identificationModule': {'nctId': 'NCT06482502', 'briefTitle': "Validity of the 6-Minute Pegboard and Ring Test in Parkinson's Patients", 'organization': {'class': 'OTHER', 'fullName': 'Karadeniz Technical University'}, 'officialTitle': "Investigation of the Validity and Reliability of the 6-Minute Pegboard and Ring Test in Parkinson's Patients for Upper Extremity Endurance Assessments", 'orgStudyIdInfo': {'id': '2024/77'}}, 'armsInterventionsModule': {'armGroups': [{'label': '6-MPRT Group', 'description': 'There is 1 group in the study. All assessments are made on the same group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34520', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Call Center', 'role': 'CONTACT', 'email': 'info@medilife.com.tr', 'phone': '+90 (212) 866 80 80'}, {'name': 'Adem Aktürk, PhD', 'role': 'CONTACT', 'email': 'aakturk@gelisim.edu.tr', 'phone': '+90 533 310 23 15'}], 'facility': 'İstanbul Medilife Beylikdüzü Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Emre Şenocak, PhD', 'role': 'CONTACT', 'email': 'emre.senocak@windowslive.com', 'phone': '+90 553 569 56 92'}], 'overallOfficials': [{'name': 'Murat Emirzeoğlu, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Karadeniz Technical University'}, {'name': 'Adem Aktürk, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'İstanbul Gelişim University'}, {'name': 'Tuğba Eyigürbüz, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Bağcılar Education and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emre Şenocak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Assisstant', 'investigatorFullName': 'Emre Şenocak', 'investigatorAffiliation': 'Karadeniz Technical University'}}}}