Clinical trial NCT03939559: The Efficiency of Home Based Dual Task Training in Parkinson Disease
Official title: The Efficiency of Home Based Dual Task Training in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: dual task
balance
postural control
rehabilitation
home-based exercise
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with 1-3 levels according to Hoehn Yahr scale
* Have 3 or fewer scores in the Freezing of Gait Questionnaire
* Obtain at least 24 points from the Mini Mental State Assessment test
* Independent walking on a flat surface without an auxiliary device

Exclusion Criteria:

* Serious hearing or vision problems
* Have any cardiac or orthopedic disorder that may prevent walking be
* Any other neurological disorder (eg, dementia, cerebrovascular disease)
* To have a level of education of less than 5 years.

Primary outcomes:
measure: Mini Best Test
timeFrame: 8 weeks
measure: Wii Balance Board
timeFrame: 8 weeks
measure: Biodex Balance System
timeFrame: 8 weeks
measure: Timed Up and Go Test
timeFrame: 8 weeks
measure: Gait Assessment with G walk
timeFrame: 8 weeks
Secondary outcomes:
measure: Activity Balance Confidence Scale
timeFrame: 8 weeks
measure: Parkinson Disease Questionnaire- 39
timeFrame: 8 weeks
measure: Number Range Test
timeFrame: 8 weeks
measure: Verbal Memory Processes Test
timeFrame: 8 weeks
measure: Mental Flexibility Test
timeFrame: 8 weeks
measure: Word Fluency Test
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Yeditepe University
name: Guzin Kaya Aytutuldu, MSc.
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Yonca Zenginler Yazgan, Assist.Prof.
role: STUDY_CHAIR
References: