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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03298503
Other study ID # 201701080RINB
Secondary ID
Status Recruiting
Phase N/A
First received May 4, 2017
Last updated December 29, 2017
Start date December 5, 2017
Est. completion date July 2019

Study information

Verified date May 2017
Source National Taiwan University Hospital
Contact Cheng-Ya Huang, Ph.D.
Phone +886-3366-8131
Email rcyhuang@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 2019
Est. primary completion date December 5, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
task-priority strategies
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).

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Electroencephalography (EEG) to collect the brain activity (unit: uV) about 30 seconds for each trial, total about 30 minutes
Primary Electromyography (EMG) to collect the muscle activity (unit: mV) about 30 seconds for each trial, total about 30 minutes
Secondary Gait parameters (GAITRite) to know how the subjects walk during the trial about 30 seconds for each trial, total about 30 minutes
Secondary Center of pressure (COP) to know how the subjects stand during the trial about 30 seconds for each trial, total about 30 minutes
Secondary Tilting angle of inclinometer to know how the subjects perform the suprapostural task during the trial about 30 seconds for each trial, total about 30 minutes
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