Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT05660902
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2022-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFFECT OF EXERCISES IN PATIENTS WITH STROKE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-14', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2022-12-14', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke Specific Quality of Life Scale (SS-QOL)', 'timeFrame': 'When the first patient was included in the group.', 'description': 'The scale, which has a total of 49 items, consists of questions evaluating mobility, energy, upper extremity functioning, self-care, work/productivity, mood, social roles, family roles, vision, language, thinking, and personality traits. The items on the scale are scored according to a five-point Likert scale: 1. strongly agree, 2. partially agree, 3. undecided, 4. partially disagree, 5. strongly disagree.'}, {'measure': 'Stroke Specific Quality of Life Scale (SS-QOL)', 'timeFrame': 'İt was applied face-to-face at the end of the 2nd week', 'description': 'The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,'}, {'measure': 'Stroke Specific Quality of Life Scale (SS-QOL)', 'timeFrame': 'When called for control at the end of the 4th week', 'description': 'The scale, which has a total of 49 items, consists of questions evaluating mobility, energy,'}], 'secondaryOutcomes': [{'measure': 'Functional Independence Measure (FIM)', 'timeFrame': 'When the first patient was included in the group.', 'description': 'The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion, communication, and social cognition. In FIM, a total of 18 activities are evaluated for functional independence using a 7-point scale for each. Level 1 represents total assistance, and level 7 represents complete independence. The highest score that can be obtained in total is 126, and the lowest score is 18. There is a direct correlation between a high score and functional independence level'}, {'measure': 'Functional Independence Measure (FIM)', 'timeFrame': 'İt was applied face-to-face at the end of the 2nd week', 'description': 'The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,'}, {'measure': 'Functional Independence Measure (FIM)', 'timeFrame': 'When called for control at the end of the 4th week', 'description': 'The scale consists of 6 functional sections: self-care, sphincter, transfer, locomotion,'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Independence', 'Stroke', 'ROM Exercises', 'Quality of Life'], 'conditions': ['Stroke', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '28882175', 'type': 'BACKGROUND', 'citation': 'Munce SEP, Perrier L, Shin S, Adhihetty C, Pitzul K, Nelson MLA, Bayley MT. Strategies to improve the quality of life of persons post-stroke: protocol of a systematic review. Syst Rev. 2017 Sep 7;6(1):184. doi: 10.1186/s13643-017-0579-3.'}, {'pmid': '16749870', 'type': 'BACKGROUND', 'citation': 'Thommasen HV, Zhang W. Impact of chronic disease on quality of life in the Bella Coola Valley. Rural Remote Health. 2006 Apr-Jun;6(2):528. Epub 2006 Jun 5.'}, {'pmid': '21192249', 'type': 'BACKGROUND', 'citation': 'Young JA, Tolentino M. Neuroplasticity and its applications for rehabilitation. Am J Ther. 2011 Jan;18(1):70-80. doi: 10.1097/MJT.0b013e3181e0f1a4.'}, {'pmid': '14970894', 'type': 'BACKGROUND', 'citation': 'Xu BH, Yu RQ, Yu W, Xie B, Huang YX. [Effects of early rehabilitation on activities of daily living and complications in acute stroke patients]. Beijing Da Xue Xue Bao Yi Xue Ban. 2004 Feb;36(1):75-8. Chinese.'}, {'pmid': '15644146', 'type': 'BACKGROUND', 'citation': 'Wee HL, Cheung YB, Li SC, Fong KY, Thumboo J. The impact of diabetes mellitus and other chronic medical conditions on health-related Quality of Life: is the whole greater than the sum of its parts? Health Qual Life Outcomes. 2005 Jan 12;3:2. doi: 10.1186/1477-7525-3-2.'}]}, 'descriptionModule': {'briefSummary': 'Aim: This study was conducted as a randomized controlled experimental study to determine the effect of ROM exercises applied to individuals who had a stroke on functional independence and quality of life.\n\nDesign: This study was conducted as a randomized controlled experimental study Methods: The study was conducted with 80 individuals, 40 of whom were in the intervention group and 40 in the control group, who received inpatient treatment in the neurology service of a regional city hospital, and met the inclusion criteria. Planned ROM exercises were applied to the individuals in the intervention group 3 times a day for 2 weeks, and no application was made to the control group other than routine treatment. Data were collected by the researcher using the Questionnaire Form, Patient Information Form, Functional Independence Scale and Stroke Specific Quality of Life Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being over 18 years old,\n* Coming to the hospital within 72 hours of having a stroke,\n* A definitive diagnosis of Cerebrovascular Diseases according to the diagnostic criteria,\n* Having a hemiplegic condition,\n* Having a score of 13 or higher on the Glasgow Coma Scale,\n* Not to be involved in any special exercise program other than the service routine,\n* Having approval from the clinician about there is no harm in doing ROM exercises,\n* Agreeing to participate in the study\n\nExclusion Criteria:\n\n* People with quadriplegia/tetraplegia,\n* Those with psychiatric illnesses,\n* Those who have any extremity amputated,\n* Those who have open wounds that prevent exercise and cause bleeding,\n* Those with fractures in their body and those who had an orthopedic operation'}, 'identificationModule': {'nctId': 'NCT05660902', 'briefTitle': 'EFFECT OF EXERCISES IN PATIENTS WITH STROKE', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'THE EFFECT OF EXERCISES ON FUNCTIONAL INDEPENDENCE AND QUALITY OF LIFE IN INDIVIDUALS WITH A STROKE', 'orgStudyIdInfo': {'id': 'SVHROM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients in this group continued their routine medical treatment program without any treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Patients in this group continued their routine medical treatment program without any treatment. Moreover, ROM exercises were performed by the researcher and health personnel trained by the researcher 3 times a day for 2 weeks, approximately 30 minutes.', 'interventionNames': ['Other: ROM Exercises']}], 'interventions': [{'name': 'ROM Exercises', 'type': 'OTHER', 'otherNames': ['Intervention Group'], 'description': 'The patients were evaluated by the physician, they were put into practice when their condition was stable within the first 72 hours. In addition to their routine treatments, according to the ROM exercise protocol, which was created by taking expert opinions and reviewing the literature ROM exercises were performed by the researcher and health personnel trained by the researcher 3 times a day for 2 weeks, approximately 30 minutes. The movements were started with the upper extremity on the unaffected side and then moved to the affected upper extremity. After the exercise applied to the affected upper extremity was finished, the same exercise was applied to the intact lower extremity and the affected lower extremity. Only the resistance points were mobilized and the exercise applied in each joint was repeated at least three times without applying extra force.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'ERciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Özlem Ceyhan', 'investigatorAffiliation': 'TC Erciyes University'}}}}