Dual Task Practice in Parkinson's Disease

NCT01375413 | Completed Phase 3 DMC

• 2 other identifiers: Gossweiler FoundationDuality-Gossweiler
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Gait; Rehabilitation; Cognition; Freezing of gait

Outcome Measures

Primary Outcomes (1)

• Gait speed during dual task conditions (untrained Auditory Stroop task, trained Digit Span)

  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.

  24 weeks

Secondary Outcomes (2)

• Functional Dual task, single task gait measures, cognitive outcomes, Freezing of Gait Questionnaire, Quality of life scores (PDQ39)

  24 weeks

• Fall rate as determined by weekly phonecall

  24 weeks

Study Arms (2)

Integrated dual task training

EXPERIMENTAL

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

Consecutive task training

ACTIVE COMPARATOR

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

Interventions

physical therapy BEHAVIORAL

Physical therapy consisting of gait training 3 times a week for 6 weeks

Also known as: Exercise

Consecutive task training; Integrated dual task training

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Deep Brain stimulation
• Living alone
• Severe medical conditions affecting gait
• Hearing problems
• Likely to change medication regimen.

Sponsors & Collaborators

• KU Leuven: lead
• University Medical Center Nijmegen: collaborator

Study Sites (1)

Department of Rehabilitation Sciences, Katholieke Universiteit Leuven

Leuven, Vlaams Brabant, B-3001, Belgium

Location

Related Publications (2)

• Strouwen C, Molenaar EA, Keus SH, Munks L, Bloem BR, Nieuwboer A. Test-Retest Reliability of Dual-Task Outcome Measures in People With Parkinson Disease. Phys Ther. 2016 Aug;96(8):1276-86. doi: 10.2522/ptj.20150244. Epub 2016 Feb 4.

  PMID: 26847010 DERIVED

• Strouwen C, Molenaar EA, Keus SH, Munks L, Munneke M, Vandenberghe W, Bloem BR, Nieuwboer A. Protocol for a randomized comparison of integrated versus consecutive dual task practice in Parkinson's disease: the DUALITY trial. BMC Neurol. 2014 Mar 27;14:61. doi: 10.1186/1471-2377-14-61.

  PMID: 24674594 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Interventions

Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alice M Nieuwboer, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 17, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 2, 2015

Record last verified: 2015-10

Locations

BE (1)