Clinical trial NCT01121627: Computer-based Cognitive Training for Parkinson Disease
Official title: Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Gait
Keywords: Computerized Cognitive training
Quality of life
Gait Function
Executive Function
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: Tel-Aviv Sourasky Medical Center
First posted: 2010-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities.

The primary study hypothesis is that computer-based training aimed at improving executive function will have a beneficial effect on gait functions.

Detailed description: Parkinson Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities. Previous studies have revealed some relation between cognitive states and physical functions in healthy adults. Few studies have examined the effect of computer-based cognitive training on various populations. These studies showed a positive emotional-cognitive effect in those populations. This type of intervention plan was also applied to PD patients. However, there are no reports on the effect of intentional cognitive training on gait functions. The purpose of the study is to assess whether cognitive training, designed to improve EF ability, can also improve gait function in PD patients.

Eligibility criteria: Inclusion Criteria:

1. Idiopathic PD.
2. Aged 50-80, living in north region of Israel.
3. Receive regular medications for PD.
4. Not suffering from irregular cognitive disturbance or MMSE\<25.
5. Measured 1-3 on the Hoehn \& Yahr scale.
6. Have access to a computer and the ability to operate it.

Exclusion Criteria:

1. Brain operation, including DBS transplant.
2. History of orthopedic problems that can impair gait (hip/knee fractures and back problems).
3. Orthopedic operation on lower limbs performed no later than six months prior to the beginning of the study.
4. Unbalanced general health: uncontrolled diabetes or blood pressure, etc.
5. Inability to walk independently.
6. Immunodeficiency diseases, active cancer, ischemic diseases.
7. Vision impairment, partial/full blindness.
8. Having participated in similar research or cognitive assessment during the previous year.
9. Have received cognitive or gait training under physical therapy or other programs.

Primary outcomes:
measure: Gait Function
timeFrame: 18 weeks
Secondary outcomes:
measure: Executive function
timeFrame: 18 weeks
measure: Quality of life.
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Clalit Health Services, Haifa and Western Galilee District
Study officials:
affiliation: Clalit Health Services
name: Uzi Milman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel-Aviv Sourasky Medical Center
name: Jeffrey M Hausdorff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tel-Aviv Sourasky Medical Center
name: Anat Mirelman, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Clalit Health Services
name: Hagit Atias, BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milman U, Atias H, Weiss A, Mirelman A, Hausdorff JM. Can cognitive remediation improve mobility in patients with Parkinson's disease? Findings from a 12 week pilot study. J Parkinsons Dis. 2014;4(1):37-44. doi: 10.3233/JPD-130321.