The aim of this study was to investigate the effects of dual task home based exercise program on balance, gait and cognitive functions. The study is planned to include 60 patients with Parkinson's disease, whose levels are 1-3 according to the Hoehn-Yahr scale and will be admitted to Istanbul University Capa Medical Faculty Neurology Department Movement and Behavior Disorders Unit between June 2019 and February 2020. The aim of the study, duration, possible side effects of treatment will be given to the volunteers to participate in the study. The "Informed Consent Form am prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul Faculty of Medicine will be approved and the study will be conducted in accordance with the Declaration of Helsinki.
Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. Both groups will be given information with brochures containing the importance of exercise in Parkinson's disease and will be given DVD copies with weekly recordings. The time and activity schedule created at the end of the brochures will be required to record daily home exercises of the patients. In the balance exercises group; static, dynamic and functional balance exercise packages will be taught in Parkinson 's disease. In the dual task based balance exercises group; motor or cognitive dual task training will be combined these static dynamic and functional balance exercises. In both groups, exercises will be performed 3 days a week for 8 weeks.
Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease | Procedure: Static, dynamic and functional balance exercises Procedure: Static, dynamic and functional balance exercises with dual task | Not Applicable |
The aim of this study was to investigate the effects of dual task home based exercise program on balance, gait and cognitive functions. The study is planned to include 60 patients with Parkinson's disease, whose levels are 1-3 according to the Hoehn-Yahr scale and will be admitted to Istanbul University Capa Medical Faculty Neurology Department Movement and Behavior Disorders Unit between June 2019 and February 2020. The aim of the study, duration, possible side effects of treatment will be given to the volunteers to participate in the study. The "Informed Consent Form am prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul Faculty of Medicine will be approved and the study will be conducted in accordance with the Declaration of Helsinki.
Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. Both groups will be given information with brochures containing the importance of exercise in Parkinson's disease and DVD copies where the exercises are recorded weekly. The time and activity schedule created at the end of the brochures, daily recording of home exercises of the patients will be requested. Home exercise training and assessments will be provided by different physiotherapists. The evaluator physiotherapist will be blind to the treatment group to which the patient belongs. In the balance exercises group; 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session. In the dual task based balance exercises group; 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session.
The number of subjects to be taken for each group in the 95% confidence interval was considered to be 26, considering the minimal clinical significant change (Minimal Clinically Important Difference, MCID) 3.5 for the Timed Up and Go Test. Considering that the patients did not continue treatment, it was decided to take 30 patients to each group and to carry out the study with a total of 60 patients. The primary outcomes are Mini Best Test,Timed Get Up and Go Test. Also objective datas will be obtained from Biodex Balance System, Wii Balance Board and G Walk Sensory Walking System.The secondary outcome measures include activity balance confidence scale, Parkinson's Disease Questionnaire-39 and cognitive tests such as number range test, verbal memory processes test, mental flexibility and word fluency test.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Home exercise training and assessments will be provided by different physiotherapists. The evaluator physiotherapist will be blind to the treatment group to which the patient belongs |
Primary Purpose: | Treatment |
Official Title: | The Efficiency of Home Based Dual Task Training in Parkinson Disease |
Estimated Study Start Date : | June 10, 2019 |
Estimated Primary Completion Date : | September 10, 2019 |
Estimated Study Completion Date : | February 10, 2020 |
Arm | Intervention/treatment |
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Experimental: Balance Exercises Group
Balance exercises group, 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session
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Procedure: Static, dynamic and functional balance exercises
In the first group (G1), 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks
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Experimental: Dual Task Based Balance Exercises Group
Dual task based balance exercises group, 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks.
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Procedure: Static, dynamic and functional balance exercises with dual task
In the second group (G2), 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks.
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With the Wii Balance Board (WDT), the patients' static balances will be evaluated.
The WDT includes a component similar to a typical force platform with four strain gauge based load sensors that can obtain data about changes in the pressure center and can be wirelessly connected to a computer via Bluetooth.
Ages Eligible for Study: | 30 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Burcu Ersoz Huseyinsinoglu, Assoc.Prof. | +905427274316 | burcu.ersoz@istanbul.edu.tr |
Study Chair: | Guzin Kaya Aytutuldu, MSc. | Yeditepe University | |
Study Chair: | Yonca Zenginler Yazgan, Assist.Prof. | Istanbul University-Cerrahpasa |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 3, 2019 | ||||||
First Posted Date ICMJE | May 7, 2019 | ||||||
Last Update Posted Date | May 14, 2019 | ||||||
Estimated Study Start Date ICMJE | June 10, 2019 | ||||||
Estimated Primary Completion Date | September 10, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | The Efficiency of Home Based Dual Task Training in Parkinson Disease | ||||||
Official Title ICMJE | The Efficiency of Home Based Dual Task Training in Parkinson Disease | ||||||
Brief Summary |
The aim of this study was to investigate the effects of dual task home based exercise program on balance, gait and cognitive functions. The study is planned to include 60 patients with Parkinson's disease, whose levels are 1-3 according to the Hoehn-Yahr scale and will be admitted to Istanbul University Capa Medical Faculty Neurology Department Movement and Behavior Disorders Unit between June 2019 and February 2020. The aim of the study, duration, possible side effects of treatment will be given to the volunteers to participate in the study. The "Informed Consent Form am prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul Faculty of Medicine will be approved and the study will be conducted in accordance with the Declaration of Helsinki. Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. Both groups will be given information with brochures containing the importance of exercise in Parkinson's disease and will be given DVD copies with weekly recordings. The time and activity schedule created at the end of the brochures will be required to record daily home exercises of the patients. In the balance exercises group; static, dynamic and functional balance exercise packages will be taught in Parkinson 's disease. In the dual task based balance exercises group; motor or cognitive dual task training will be combined these static dynamic and functional balance exercises. In both groups, exercises will be performed 3 days a week for 8 weeks. |
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Detailed Description |
The aim of this study was to investigate the effects of dual task home based exercise program on balance, gait and cognitive functions. The study is planned to include 60 patients with Parkinson's disease, whose levels are 1-3 according to the Hoehn-Yahr scale and will be admitted to Istanbul University Capa Medical Faculty Neurology Department Movement and Behavior Disorders Unit between June 2019 and February 2020. The aim of the study, duration, possible side effects of treatment will be given to the volunteers to participate in the study. The "Informed Consent Form am prepared in accordance with the standards determined by the Clinical Research Ethics Committee of Istanbul Faculty of Medicine will be approved and the study will be conducted in accordance with the Declaration of Helsinki. Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. Both groups will be given information with brochures containing the importance of exercise in Parkinson's disease and DVD copies where the exercises are recorded weekly. The time and activity schedule created at the end of the brochures, daily recording of home exercises of the patients will be requested. Home exercise training and assessments will be provided by different physiotherapists. The evaluator physiotherapist will be blind to the treatment group to which the patient belongs. In the balance exercises group; 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session. In the dual task based balance exercises group; 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks. After the four weeks, the exercises should be progressed in the last 4 weeks in the second training session. The number of subjects to be taken for each group in the 95% confidence interval was considered to be 26, considering the minimal clinical significant change (Minimal Clinically Important Difference, MCID) 3.5 for the Timed Up and Go Test. Considering that the patients did not continue treatment, it was decided to take 30 patients to each group and to carry out the study with a total of 60 patients. The primary outcomes are Mini Best Test,Timed Get Up and Go Test. Also objective datas will be obtained from Biodex Balance System, Wii Balance Board and G Walk Sensory Walking System.The secondary outcome measures include activity balance confidence scale, Parkinson's Disease Questionnaire-39 and cognitive tests such as number range test, verbal memory processes test, mental flexibility and word fluency test. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups. Masking: Single (Outcomes Assessor)Masking Description: Home exercise training and assessments will be provided by different physiotherapists. The evaluator physiotherapist will be blind to the treatment group to which the patient belongs Primary Purpose: Treatment
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Condition ICMJE | Parkinson Disease | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Unknown status | ||||||
Estimated Enrollment ICMJE |
60 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | February 10, 2020 | ||||||
Estimated Primary Completion Date | September 10, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 30 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Not Provided | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03939559 | ||||||
Other Study ID Numbers ICMJE | İstanbulUCerrahpasa | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Burcu Ersoz Huseyinsinoglu, Istanbul University-Cerrahpasa | ||||||
Study Sponsor ICMJE | Istanbul University-Cerrahpasa | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Istanbul University-Cerrahpasa | ||||||
Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |