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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03895125
Other study ID # 201812110RINC
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 7, 2019
Est. completion date February 12, 2020

Study information

Verified date March 2019
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

[year1]

1. To compare the effects of dual-task training with two different task priority instruction in people with Parkinson's disease and healthy controls on dual-task weight shifting performances.

2. Investigate the changes of brain activities and functional connectivity after dual-task training with different task priority instructions.

[year 2-3]

To investigate the learning effects of walking with internal/external focus on walking automaticity and brain plasticity in dual-task walking training for PD patients with/without freezing of gait.


Description:

Postural-suprapostural task is defined as postural control takes place while another concurrent task is being performed, belonging to dual-task paradigms. Effective dual-task training is important to patients with Parkinson disease (PD), because they often lose balance and fall in dual-task conditions. Attentional strategy includes 1) task-priority between postural and suprapostural tasks and 2) internal and external focus for the postural task, which is the critical factor for both dual-task control and motor learning. However, the appropriateness of attentional strategy has not been investigated in dual-task training in patients with PD. Besides, there is lack of neural evidence of brain plasticity for previous studies about dual-task training in patients with PD. With the uses of EEG, EMG and behavioral measures, the purpose of this 3-year research project is to investigate the differences in performance quality and intrinsic neural mechanisms of dual-task training in PD, by adopting task-priority strategy and internal/external strategy during weight-shifting and walking. In the first year, the investigators will characterize task-priority effect (posture-priority vs. supraposture-priority) on dual-task training, with a special focus on modulation of brain plasticity and muscle activity patterns in weight-shifting posture for patients with PD. In the second and third years, the learning effects of walking internal/external focus on walking automaticity and brain plasticity will be investigated in dual-task walking training for PD patients with/without freezing of gait. Besides, the transfer effects of dual-task learning will be also investigated on medication "off" state. The present project is expected to have significant contributions not only to gain a better insight to neural correlates of dual-task training with different attentional strategies under weight-shifting and walking, but to optimize treatment strategy for PD patients with balance or dual-tasking disturbances.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date February 12, 2020
Est. primary completion date February 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility [year1]

Inclusion criteria:

1. For people with Parkinson's disease

1. modified Hoehn & Yahr stage 2-3

2. without dementia and able to follow instructions

2. For healthy controls

age and gender matched healthy subjects as control group

Exclusion criteria:

1. MMSE < 26

2. with other disease that may influence balance ability

3. with marked action and postural tremor

[year2-3] inclusion criteria:

1. idiopathic Parkinson's disease

2. modified Hoehn & Yahr stage 2-3

3. without marked action or postural tremor

exclusion criteria:

1. MMSE < 26

2. with other disease that may influence balance ability

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
[year1] dual-task training with task priority strategy
postural focus: focus mainly on postural performances while dual-tasking suprapostural focus: focus mainly on suprapostural performances while dual-tasking
[year2-3] dual-task training with internal and external focus
internal focus: focus mainly on body movements external focus: focus mainly on object in the environment

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary postural performance measuring the amount of body weight shifting (unit: kg) about 36 seconds for each trial for a total of 25 minutes
Primary suprapostural performance measuring the rotation angle of box on the hand (unit: degree) about 36 seconds for each trial for a total of 25 minutes
Primary Walking speed collecting by using the GAITRite electronic walkway (CIR systems, Inc. ,USA) 24 inches(61cm) wide and 192 inches (488cm, 16ft) long, total 18,432 sensor (unit: m/s) about 10-20 seconds for each trial
Primary Cadence collecting by using the GAITRite (unit: step/s) about 10-20 seconds for each trial
Primary Gait symmetry collecting single leg supporting time of right and left leg by using the GAITRite about 10-20 seconds for each trial
Secondary electroencephalography (EEG) to collect the brain activity (unit: uV) about 36 seconds for each trial for a total of 25 minutes
Secondary electromyography (EMG) to collect the muscle activity (unit: mV) about 36 seconds for each trial for a total of 25 minutes
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