NCT03298503

Brief Summary

Postural-suprapostural task is defined as postural control takes place while at least one other concurrent task is being performed. In a postural-suprapostural task, appropriate prioritization of is necessary to achieve task goals and maintain postural stability. Therefore, regarding to impose task prioritization in a postural-suprapostural task, the optimal task-priority strategy for PD patients is still an issue of debate. With the uses of EEG, EMG and behavioral measures, the purpose of this project is to investigate the differences in performance quality and intrinsic neural mechanisms of a postural-suprapostural task for PD patients, by adopting posture-focus and suprapostural-focus strategies during standing and walking. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of concurrent postural and suprapostural tasks with different task prioritization under standing and walking, but to optimize treatment strategy for PD patients with balance or dual-tasking disturbances.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

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 4, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 5, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2017

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 2, 2018

Status Verified

May 1, 2017

Enrollment Period

Same day

First QC Date

May 4, 2017

Last Update Submit

December 29, 2017

Conditions

Keywords

Parkinson's diseaseposture balanceattention

Outcome Measures

Primary Outcomes (2)

  • Electroencephalography (EEG)

    to collect the brain activity (unit: uV)

    about 30 seconds for each trial, total about 30 minutes

  • Electromyography (EMG)

    to collect the muscle activity (unit: mV)

    about 30 seconds for each trial, total about 30 minutes

Secondary Outcomes (3)

  • Gait parameters (GAITRite)

    about 30 seconds for each trial, total about 30 minutes

  • Center of pressure (COP)

    about 30 seconds for each trial, total about 30 minutes

  • Tilting angle of inclinometer

    about 30 seconds for each trial, total about 30 minutes

Study Arms (2)

early stage or non-freezers PD

ACTIVE COMPARATOR

early stage defined as modified Hoehn and Yahr scale 1, 1.5 and 2, means that symptoms involved unilateral or bilateral without impairment of balance. non-freezers defined as without freezing of gait, means that patients without transient inability to generate effective stepping.

Other: task-priority strategies

moderate stage or freezers PD

EXPERIMENTAL

moderate stage defined as modified Hoehn and Yahr scale 2.5 and 3, means that symptoms involved unilateral or bilateral without impairment of balance. freezers defined as with freezing of gait, means that patients have transient inability to generate effective stepping.

Other: task-priority strategies

Interventions

posture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on postural task (standing/walking). supraposture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on suprapostural task (stabilize the tray).

early stage or non-freezers PDmoderate stage or freezers PD

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with Parkinson's Disease in H\&Y stage from stage 1 to stage 3
  • without other neurological disease with balance impairment
  • can stand and walk without aids for at least 30 seconds

You may not qualify if:

  • Mini-Mental State Examination \> 27
  • Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) \< 10
  • Hamilton Depression Rating Scale (HAM-D) \< 17
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 10048, Taiwan

RECRUITING

Related Publications (9)

  • Peterson DS, Fling BW, Mancini M, Cohen RG, Nutt JG, Horak FB. Dual-task interference and brain structural connectivity in people with Parkinson's disease who freeze. J Neurol Neurosurg Psychiatry. 2015 Jul;86(7):786-92. doi: 10.1136/jnnp-2014-308840. Epub 2014 Sep 15.

    PMID: 25224677BACKGROUND
  • Kelly VE, Eusterbrock AJ, Shumway-Cook A. A review of dual-task walking deficits in people with Parkinson's disease: motor and cognitive contributions, mechanisms, and clinical implications. Parkinsons Dis. 2012;2012:918719. doi: 10.1155/2012/918719. Epub 2011 Oct 27.

    PMID: 22135764BACKGROUND
  • Shumway-Cook A, Woollacott M, Kerns KA, Baldwin M. The effects of two types of cognitive tasks on postural stability in older adults with and without a history of falls. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M232-40. doi: 10.1093/gerona/52a.4.m232.

    PMID: 9224435BACKGROUND
  • Beck EN, Ehgoetz Martens KA, Almeida QJ. Freezing of Gait in Parkinson's Disease: An Overload Problem? PLoS One. 2015 Dec 17;10(12):e0144986. doi: 10.1371/journal.pone.0144986. eCollection 2015.

    PMID: 26678262BACKGROUND
  • Mitra S, Fraizer EV. Effects of explicit sway-minimization on postural--suprapostural dual-task performance. Hum Mov Sci. 2004 Jun;23(1):1-20. doi: 10.1016/j.humov.2004.03.003.

    PMID: 15201038BACKGROUND
  • Vervoort G, Heremans E, Bengevoord A, Strouwen C, Nackaerts E, Vandenberghe W, Nieuwboer A. Dual-task-related neural connectivity changes in patients with Parkinson' disease. Neuroscience. 2016 Mar 11;317:36-46. doi: 10.1016/j.neuroscience.2015.12.056. Epub 2016 Jan 5.

    PMID: 26762801BACKGROUND
  • Knaepen K, Mierau A, Tellez HF, Lefeber D, Meeusen R. Temporal and spatial organization of gait-related electrocortical potentials. Neurosci Lett. 2015 Jul 10;599:75-80. doi: 10.1016/j.neulet.2015.05.036. Epub 2015 May 21.

    PMID: 26003448BACKGROUND
  • Huang CY, Chen YA, Wu RM, Hwang IS. Neural Oscillations and Functional Significances for Prioritizing Dual-Task Walking in Parkinson's Disease. J Parkinsons Dis. 2024;14(2):283-296. doi: 10.3233/JPD-230245.

  • Hung YT, Chen LC, Wu RM, Huang CY. The Effects of Task Prioritization on Dual-Tasking Postural Control in Patients With Parkinson Disease Who Have Different Postural Impairments. Arch Phys Med Rehabil. 2020 Jul;101(7):1212-1219. doi: 10.1016/j.apmr.2020.02.014. Epub 2020 Mar 28.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Cheng-Ya Huang, Ph.D.

    School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Ya Huang, Ph.D.

CONTACT

Fu-Chang Tsai, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

October 2, 2017

Study Start

December 5, 2017

Primary Completion

December 5, 2017

Study Completion

July 1, 2019

Last Updated

January 2, 2018

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations