Computer-based Cognitive Training for Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Effects of Computer-based Cognitive Training on Gait Function in Individuals With Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121627
• Other study ID #: K-10-0036-ctil
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: August 21, 2015
• Start date: July 2010
• Est. completion date: April 2012

Study information

• Verified date: August 2015
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gait
• Parkinson Disease

Intervention

Other:
• Computerized cognitive training
A 12 week computerized cognitive training at home with the Attengo™ software program.

Locations

Country	Name	City	State
Israel	Clalit Health Services, Haifa and Western Galilee District	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Clalit Health Services	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 weeks	No
Secondary	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.	18 weeks	No
Secondary	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.	18 weeks	No