Parkinson Disease Clinical Trial
Official title:
The Efficiency of Home Based Dual Task Training in Parkinson Disease
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.
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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