Dual Task Practice in Parkinson's Disease (Duality-PD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Katholieke Universiteit Leuven
Sponsor:
Collaborator:
University Medical Center Nijmegen
Information provided by (Responsible Party):
Alice Nieuwboer, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01375413
First received: June 15, 2011
Last updated: October 10, 2014
Last verified: October 2014
  Purpose

The ability to perform two or more tasks together is impaired in Parkinson's Disease (PD). Based on pilot work we hypothesize that dual tasking is amenable to training in PD and will not compromise safety. In the proposed study we will therefore collect high level evidence on whether 6 weeks of integrated dual task gait training is more effective than consecutive task practice. The investigators will use a randomized, single blind study design and conduct the same protocols in two academic centers (Katholieke Universiteit Leuven and Radboud Universiteit Nijmegen). The investigators intend to test an experimental condition which consists of focused dual task training in the home using a novel program of personalized cognitive tasks. The aim of dual task training is to teach motor-cognitive task integration and achieve optimal levels of automaticity and functionality. The control arm will receive gait practice and separate cognitive training of the same intensity, but offered consecutively. We will test the hypothesis that dual task training (integration) will have more pronounced effects on complex gait than consecutive task training.

Sub-analysis will be conducted on patients with and without freezing of gait. The investigators expect that integrated dual task training may be less effective in patients with freezing, due to the increased fall risk and impaired cognitive profiles.

Overall, this project will provide evidence to support future directions for motor learning and innovative rehabilitation targets.


Condition Intervention Phase
Parkinson's Disease
Behavioral: physical therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Motor Learning in Parkinson's Disease: a Randomized Comparison of Integrated Versus Consecutive Dual Task Training

Resource links provided by NLM:


Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • Gait speed during dual task conditions (untrained Auditory Stroop task, trained Digit Span) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change scores will be calculated, comparing the change over the two baseline timepoints with the change after 6 week intervention. The change between the first baseline timepoint and the last timepoint (24 weeks) will also be compared.


Secondary Outcome Measures:
  • Functional Dual task, single task gait measures, cognitive outcomes, Freezing of Gait Questionnaire, Quality of life scores (PDQ39) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Change scores will be calculated, comparing the change over the two baseline timepoints with the change after 6 week intervention. The change between the first baseline timepoint and the last timepoint (24 weeks) will also be compared.

  • Fall rate as determined by weekly phonecall [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Change scores will be calculated, comparing the change over the two baseline timepoints with the change after 6 week intervention. The change between the first baseline timepoint and the last timepoint (24 weeks) will also be compared.


Estimated Enrollment: 120
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated dual task training
Integrated dual task training delivered by a physiotherapist. In this training mode walking practice will be combined with simultaneously carrying out cognitive discrimination, verbal fluency and memory tasks.
Behavioral: physical therapy
Physical therapy consisting of gait training 3 times a week for 6 weeks
Other Name: Exercise
Active Comparator: Consecutive task training
Consecutive task gait training delivered by a physical therapist. In this training mode, walking practice will be conducted separately, focusing on the motor task only. Training of cognitive discrimination, verbal fluency and memory tasks will be done consecutively while the subjects are sitting.
Behavioral: physical therapy
Physical therapy consisting of gait training 3 times a week for 6 weeks
Other Name: Exercise

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Hoehn & Yahr stage II-III in the on-phase
  2. Able to walk for 10 minutes continuously
  3. Dual task interference of at least 5% using a cognitive secondary task
  4. Without cognitive impairment (MMSE > 24)
  5. On stable medication
  6. Diagnosis of Parkinson's disease made by a movement disorders specialist

Exclusion Criteria:

  1. Deep Brain stimulation
  2. Living alone
  3. Severe medical conditions affecting gait
  4. Hearing problems
  5. Likely to change medication regimen.
  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: NCT01375413

Contacts
Contact: Alice M Nieuwboer, PhD 0032 16 329119 ext 29119 alice.nieuwboer@faber.kuleuven.be
Contact: Marten Munneke, PhD 0031243614701 ext 4701 M.Munneke@neuro.umcn.nl

Locations
Belgium
Department of Rehabilitation Sciences, Katholieke Universiteit Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, B-3001
Contact: Alice Nieuwboer, PhD    003216329119    alice.nieuwboer@faber.kuleuven.be   
Contact: Hilde Feys, PhD    003216329079    Hilde.feys@faber.kuleuven.be   
Sponsors and Collaborators
Katholieke Universiteit Leuven
University Medical Center Nijmegen
Investigators
Principal Investigator: Alice M Nieuwboer, PhD Katholieke Universiteit Leuven
  More Information

No publications provided by Katholieke Universiteit Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alice Nieuwboer, Professor, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01375413     History of Changes
Other Study ID Numbers: Gossweiler Foundation, Duality-Gossweiler
Study First Received: June 15, 2011
Last Updated: October 10, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Katholieke Universiteit Leuven:
Parkinson's disease
Gait
Rehabilitation
Cognition
Freezing of gait

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 October 19, 2014