Computer-based Cognitive Training for Parkinson Disease

This study has been completed.
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01121627
First received: May 10, 2010
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Parkinson Disease
Gait
Other: Computerized cognitive training

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease

Resource links provided by NLM:


Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • Gait Function [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.


Secondary Outcome Measures:
  • Executive function [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-term cognitive and motor changes.

  • Quality of life. [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    At enrollment eligible individuals will undergo a thorough baseline assessment using a predefined set of tests and performance measurements. Within a week after enrollment each individual will receive guided training on the use of the intervention tool, the Attengo™ software program. Thereafter they will train at their homes, at least three times a week, for a period of 12 weeks. Follow up assessments will be performed within a week of the end of the training period and 4 weeks thereafter to check for long-run cognitive and motor changes.


Enrollment: 30
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized cognitive training
A 12 week computerized cognitive training
Other: Computerized cognitive training
A 12 week computerized cognitive training at home with the Attengo™ software program.

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121627

Locations
Israel
Clalit Health Services, Haifa and Western Galilee District
Haifa, Israel
Sponsors and Collaborators
Clalit Health Services
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Uzi Milman, MD Clalit Health Services
Principal Investigator: Jeffrey M Hausdorff, PhD Tel-Aviv Sourasky Medical Center
Principal Investigator: Anat Mirelman, Phd Tel-Aviv Sourasky Medical Center
Principal Investigator: Hagit Atias, BA Clalit Health Services
  More Information

No publications provided

Responsible Party: Uzi Milman, Director, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District and the Department of Family Medicine, Faculty of Medicine, Technion- Israel Institute of Technology, HAIFA, ISRAEL., Clalit Health Services
ClinicalTrials.gov Identifier: NCT01121627     History of Changes
Other Study ID Numbers: K-10-0036-ctil
Study First Received: May 10, 2010
Last Updated: May 1, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
Computerized Cognitive training
Quality of life
Gait Function
Executive Function

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 28, 2014