Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2025-12-27 @ 10:35 PM
Study NCT ID:
NCT05855161
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2023-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Rebound Therapy 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups as rebound group and control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-03', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Static Balance- Baseline', 'timeFrame': 'Assessment will be conducted before the intervention', 'description': 'Assessment will be made with the Biodex Balance System'}, {'measure': 'Static Balance- Post intervention', 'timeFrame': 'Assessment will be conducted immediately after the intervention', 'description': 'Assessment will be made with the Biodex Balance System'}, {'measure': 'Gait speed- Baseline', 'timeFrame': 'Assessment will be conducted before the intervention', 'description': 'Assessment will be made with the BTS G-Walk, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy; SN: 0213-0378) during gait'}, {'measure': 'Gait speed- Post intervention', 'timeFrame': 'Assessment will be conducted immediately after the intervention', 'description': 'Assessment will be made with the BTS G-Walk, (BTS SpA, Via della Croce Rossa, 11 Padova, Italy; SN: 0213-0378) during gait'}, {'measure': 'Knee strength- Baseline', 'timeFrame': 'Assessment will be conducted before the intervention', 'description': 'Assessment will be made with an isokinetic dynamometer (Cybex Humac Norm Testing and Rehabilitation System, CSMI, USA)'}, {'measure': 'Knee strength-Post intervention', 'timeFrame': 'Assessment will be conducted immediately after the intervention', 'description': 'Assessment will be made with an isokinetic dynamometer (Cybex Humac Norm Testing and Rehabilitation System, CSMI, USA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'rebound therapy', 'task oriented training', 'balance and walking performance'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '31516672', 'type': 'BACKGROUND', 'citation': "Daneshvar P, Ghasemi G, Zolaktaf V, Karimi MT. Comparison of the Effect of 8-Week Rebound Therapy-Based Exercise Program and Weight-Supported Exercises on the Range of Motion, Proprioception, and the Quality of Life in Patients with Parkinson's Disease. Int J Prev Med. 2019 Aug 12;10:131. doi: 10.4103/ijpvm.IJPVM_527_18. eCollection 2019."}]}, 'descriptionModule': {'briefSummary': "Today, physiotherapy approaches in Parkinson's Disease (PD) form the basis of optimal treatment together with medical and surgical treatment. It is stated that various rehabilitation interventions may be effective in the field of physiotherapy. The frequently preferred among these rehabilitation interventions is the conventional treatment approach. In the conventional treatment, various exercises are preferred to improve balance and walking, as well as stretching and strengthening. On the other hand, rebound therapy require strong integration of the neuromuscular system and provide more active use of lower extremity muscle strength. Rebound therapy have been shown to be effective in improving balance in many neurological disease groups, but there is very little study on rebound therapy in PD. It was shown that rebound therapy improve proprioceptive sense, joint range of motion and quality of life. On the other hand, no study has been found showing its effect on balance and walking. Therefore, there is a need to investigate the effectiveness of rebound therapy on balance and walking.", 'detailedDescription': 'This study is a randomized controlled study. The patients will be randomly divided into two groups as rebound and control. The rebound group will perform exercises on a trampoline, consisting of 15 minutes of trunk and extremity stretching, 10 minutes of walking, and approximately 30 minutes of task-oriented exercises, twice a week for six weeks. While the control group will follow the same program as the rebound group, they will only perform task-oriented exercises on a stable surface, unlike the rebound group. As the outcome measures, disease severity and disability, balance, and gait performance will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 40-80 years of age\n* Having diagnosed with "Parkinson\'s Disease" by a specialist physician\n* Having between 1-3 stages according to the Hoehn and Yahr Scale\n* Mini-Mental Test score more than or equal 24\n\nExclusion Criteria:\n\n\\- Any orthopedic, vision, hearing, cardiovascular, or perception problems that may affect the research results'}, 'identificationModule': {'nctId': 'NCT05855161', 'briefTitle': "Effectiveness of Rebound Therapy in Parkinson's Patients", 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': "Effectiveness of Rebound Therapy on Balance and Gait in Parkinson's Patients", 'orgStudyIdInfo': {'id': '5-PD-Rebound therapy-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rebound therapy', 'description': 'The group that will perform exercises on a trampoline.', 'interventionNames': ['Other: Rebound therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'The group that will perform exercises on a stable surface.', 'interventionNames': ['Other: Exercises on a stable surface']}], 'interventions': [{'name': 'Rebound therapy', 'type': 'OTHER', 'description': 'Participants will receive exercise-based training on a trampoline', 'armGroupLabels': ['Rebound therapy']}, {'name': 'Exercises on a stable surface', 'type': 'OTHER', 'description': 'Participants will receive exercise-based training on a stable surface', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sivas', 'country': 'Turkey (Türkiye)', 'facility': 'Sivas Cumhuriyet University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation', 'geoPoint': {'lat': 39.74833, 'lon': 37.01611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make PD data but when the statistical analysis of all data is made, all results will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sefa Eldemir', 'investigatorAffiliation': 'Cumhuriyet University'}}}}