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Computer-based Cognitive Training for Parkinson Disease

Primary Purpose

Parkinson Disease, Gait

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Computerized cognitive training
Sponsored by
Clalit Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Computerized Cognitive training, Quality of life, Gait Function, Executive Function

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clalit Health Services, Haifa and Western Galilee District

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Computerized cognitive training

Arm Description

A 12 week computerized cognitive training

Outcomes

Primary Outcome Measures

Gait Function
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
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.
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.

Full Information

First Posted
May 10, 2010
Last Updated
August 21, 2015
Sponsor
Clalit Health Services
Collaborators
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01121627
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clalit Health Services
Collaborators
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Gait
Keywords
Computerized Cognitive training, Quality of life, Gait Function, Executive Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized cognitive training
Arm Type
Experimental
Arm Description
A 12 week computerized cognitive training
Intervention Type
Other
Intervention Name(s)
Computerized cognitive training
Intervention Description
A 12 week computerized cognitive training at home with the Attengo™ software program.
Primary Outcome Measure Information:
Title
Gait Function
Description
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.
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Executive function
Description
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.
Time Frame
18 weeks
Title
Quality of life.
Description
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.
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Idiopathic PD. Aged 50-80, living in north region of Israel. Receive regular medications for PD. Not suffering from irregular cognitive disturbance or MMSE<25. Measured 1-3 on the Hoehn & Yahr scale. Have access to a computer and the ability to operate it. Exclusion Criteria: Brain operation, including DBS transplant. History of orthopedic problems that can impair gait (hip/knee fractures and back problems). Orthopedic operation on lower limbs performed no later than six months prior to the beginning of the study. Unbalanced general health: uncontrolled diabetes or blood pressure, etc. Inability to walk independently. Immunodeficiency diseases, active cancer, ischemic diseases. Vision impairment, partial/full blindness. Having participated in similar research or cognitive assessment during the previous year. Have received cognitive or gait training under physical therapy or other programs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uzi Milman, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeffrey M Hausdorff, PhD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anat Mirelman, Phd
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hagit Atias, BA
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clalit Health Services, Haifa and Western Galilee District
City
Haifa
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
24322063
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.
Results Reference
result

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Computer-based Cognitive Training for Parkinson Disease

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