NCT01121627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 12, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

May 10, 2010

Last Update Submit

August 21, 2015

Conditions

Parkinson DiseaseGait

Keywords

Computerized Cognitive trainingQuality of lifeGait FunctionExecutive Function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Executive function

    18 weeks

  • Quality of life.

    18 weeks

Study Arms (1)

Computerized cognitive training

EXPERIMENTAL

A 12 week computerized cognitive training

Other: Computerized cognitive training

Interventions

Computerized cognitive trainingOTHER

A 12 week computerized cognitive training at home with the Attengo™ software program.

Computerized cognitive training

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clalit Health Services, Haifa and Western Galilee District

Haifa, Israel

Location

Related 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.

    PMID: 24322063RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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.

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 12, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

IL(1)