- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01121627
Computer-based Cognitive Training for Parkinson Disease
Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel
- Clalit Health Services, Haifa and Western Galilee District
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Computerized cognitive training
A 12 week computerized cognitive training
|
A 12 week computerized cognitive training at home with the Attengo™ software program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait Function
Time Frame: 18 weeks
|
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.
|
18 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Executive function
Time Frame: 18 weeks
|
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.
|
18 weeks
|
|
Quality of life.
Time Frame: 18 weeks
|
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.
|
18 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Uzi Milman, MD, Clalit health services
- Principal Investigator: Anat Mirelman, Phd, Tel-Aviv Sourasky Medical Center
- Principal Investigator: Hagit Atias, BA, Clalit health services
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K-10-0036-ctil
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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