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Task-priority Effects on Postural-suprapostural Task in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
task-priority strategies
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Parkinson's disease, posture balance, attention

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

inclusion criteria:

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

exclusion criteria:

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

early stage or non-freezers PD

moderate stage or freezers PD

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Electroencephalography (EEG)
to collect the brain activity (unit: uV)
Electromyography (EMG)
to collect the muscle activity (unit: mV)

Secondary Outcome Measures

Gait parameters (GAITRite)
to know how the subjects walk during the trial
Center of pressure (COP)
to know how the subjects stand during the trial
Tilting angle of inclinometer
to know how the subjects perform the suprapostural task during the trial

Full Information

First Posted
May 4, 2017
Last Updated
December 29, 2017
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03298503
Brief Title
Task-priority Effects on Postural-suprapostural Task in Patients With Parkinson's Disease
Official Title
Effects of Task Prioritization on Postural-suprapostural Task and Brain Activity in Parkinson's Disease With Different Balance Ability: During Standing and Walking
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
December 5, 2017 (Actual)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. Some studies support that a "posture-first" strategy is favored by patients with Parkinson disease (PD) in order to secure stance stability, but this comes at the cost of reduced suprapostural performance. In addition, overemphasizing on postural task might deteriorate automatic control of posture resulting in increased postural instability, and the best task-priority strategy might vary with balance ability of PD patients. 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 2-year research 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. In the first year, we will characterize task prioritization effect on reciprocity of a postural-suprapostural task, with a special focus on modulation of brain and muscle activity patterns in standing posture for early stage (modified H & Y: 1, 1.5 and 2) and moderate stage (modified H & Y: 2.5 and 3) PD patients. In the second year, the appropriate task prioritization, walking automaticity and power/connectivity of brain areas will be investigated in walking for PD patients with/without freezing of gait. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, posture balance, attention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
early stage or non-freezers PD
Arm Type
Active Comparator
Arm Description
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.
Arm Title
moderate stage or freezers PD
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
task-priority strategies
Intervention Description
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).
Primary Outcome Measure Information:
Title
Electroencephalography (EEG)
Description
to collect the brain activity (unit: uV)
Time Frame
about 30 seconds for each trial, total about 30 minutes
Title
Electromyography (EMG)
Description
to collect the muscle activity (unit: mV)
Time Frame
about 30 seconds for each trial, total about 30 minutes
Secondary Outcome Measure Information:
Title
Gait parameters (GAITRite)
Description
to know how the subjects walk during the trial
Time Frame
about 30 seconds for each trial, total about 30 minutes
Title
Center of pressure (COP)
Description
to know how the subjects stand during the trial
Time Frame
about 30 seconds for each trial, total about 30 minutes
Title
Tilting angle of inclinometer
Description
to know how the subjects perform the suprapostural task during the trial
Time Frame
about 30 seconds for each trial, total about 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
inclusion criteria: 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 exclusion criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng-Ya Huang, Ph.D.
Phone
+886-3366-8131
Email
rcyhuang@ntu.edu.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Fu-Chang Tsai, Ph.D.
Phone
+886-2312-3456
Ext
88576
Email
fctsai@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Ya Huang, Ph.D.
Organizational Affiliation
School & Graduate Institute of Physical Therapy, College of Medicine, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng-Ya Huang, Ph.D.
Phone
+886-3366-8131
Email
rcyhuang@ntu.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25224677
Citation
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.
Results Reference
background
PubMed Identifier
22135764
Citation
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.
Results Reference
background
PubMed Identifier
9224435
Citation
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.
Results Reference
background
PubMed Identifier
26678262
Citation
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.
Results Reference
background
PubMed Identifier
15201038
Citation
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.
Results Reference
background
PubMed Identifier
26762801
Citation
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.
Results Reference
background
PubMed Identifier
26003448
Citation
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.
Results Reference
background
PubMed Identifier
32234414
Citation
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.
Results Reference
derived

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Task-priority Effects on Postural-suprapostural Task in Patients With Parkinson's Disease

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