The Efficiency of Home Based Dual Task Training in Parkinson Disease

NCT03939559 | Unknown

• 1 other identifier: İstanbulUCerrahpasa
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

dual task; balance; postural control; rehabilitation; home-based exercise

Outcome Measures

Primary Outcomes (5)

• Mini Best Test

  The Mini-BEST test to be used for dynamic balance assessment is a 14-item balance scale and is a one-dimensional and highly reliable measurement method that requires approximately 15 minutes to complete.

  8 weeks

• Wii Balance Board

  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.

  8 weeks

• Biodex Balance System

  The Biodex Balance System (BBS; Biodex Medical System Inc., Shirley, NY, USA) will be used to measure the displacement of the foot pressure center (CoP).

  8 weeks

• Timed Up and Go Test

  Timed Up and Go Test is a simple, widely used and rapid test for assessing mobility, balance and fall risk

  8 weeks

• Gait Assessment with G walk

  Spatio temporal parameters of the gait are planned to be evaluated using the G-walk sensor.

  8 weeks

Secondary Outcomes (6)

• Activity Balance Confidence Scale

  8 weeks

• Parkinson Disease Questionnaire- 39

  8 weeks

• Number Range Test

  8 weeks

• Verbal Memory Processes Test

  8 weeks

• Mental Flexibility Test

  8 weeks

Study Arms (2)

Balance Exercises Group

EXPERIMENTAL

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

Procedure: Static, dynamic and functional balance exercises

Dual Task Based Balance Exercises Group

EXPERIMENTAL

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.

Procedure: Static, dynamic and functional balance exercises with dual task

Interventions

Static, dynamic and functional balance exercises PROCEDURE

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

Balance Exercises Group

Static, dynamic and functional balance exercises with dual task PROCEDURE

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.

Dual Task Based Balance Exercises Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Guzin Kaya Aytutuldu, MSc.

  Yeditepe University

  STUDY CHAIR

• Yonca Zenginler Yazgan, Assist.Prof.

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Burcu Ersoz Huseyinsinoglu, Assoc.Prof.

CONTACT

+905427274316; burcu.ersoz@istanbul.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Model Details: Patients who meet the inclusion criteria of the study will be included in the study and will be randomized into two groups.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 7, 2019
• Study Start: June 10, 2019
• Primary Completion: September 10, 2019
• Study Completion: February 10, 2020
• Last Updated: May 14, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share