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Completed

NCT Number: NCT03972241

Strategy for Daily Activity Improvement in Patients With Parkinson's Disease

The symptoms and signs of patients with Parkinson's disease (PD) include bradykinesia, rigidity, tremor and poor sensory integration, which result in mobility disability. Present integrated research project tries to investigate the effects of different physical therapy interventions on daily activities in patients with PD. This integrated research project includes 3 subprojects as follows. The title of Subproject 1 is "Three dimensional motion analysis of daily activities with functional insole in Parkinsonian patients". The title of Subproject 2 is "Immediate and long-term effects of novel plantar mechanical device on postural control in standing and gait performance in people with Parkinson's disease". The title of Subproject 3 is "Upper extremity hand function and coordination during functional movement in patients with Parkinson's disease".

This multidisciplinary research project collaborates with Department of Physical Therapy, and Department of Medicine in Tzu Chi University. Furthermore, this integrated study also works with Department of Neurology, Department of Neurosurgery, as well as Department of Rehabilitation in Tzu Chi Hospital to improve the mobility in patients with PD.

This is a three-year integrated project, and the common purposes of this project in each are as follows. In the first year, it is to compare the daily functional difference between the healthy and the Parkinsonian patients. In the second year, it is to examine the immediate and short-term effects of different interventions on daily activities in Parkinsonian patients.The third year is for upper extremity functional assessment.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tzu Chi University

Hualien City, Hualien County, 97004, Taiwan

About this study

In the first year, it is to compare the functional difference of biomechanics and motor control between the healthy and the Parkinsonian patients. In the second year, it is to examine the immediate and short-term effects of functional foot insole and the kinetic training on daily activities in Parkinsonian patients. In the third year, it is to examine the hand tremor during drawing, and the coordination during reaching in Parkinsonian patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stage II~IV of Hoehn and Yahr Staging of Parkinson's Disease and normal subjects, whose age between 40~75.

Exclusion criteria

  • Brain injury or hemorrhage, including stroke, etc.

Treatment and study plan

foot insole

Device

arch support and toe extension

Other names: spiral drawing

Primary outcomes

  1. Ambulation

    Time frame: 1 year

    gait cycle

Secondary outcomes

  1. Foot pressure

    Time frame: 1 year

    center of pressure

  2. Spiral drawing

    Time frame: 1 year

    Figure plot

  3. Coordination

    Time frame: 1 year

    Reaching movement

Sponsors and collaborators

Lead sponsor

Kwan-Hwa Lin

Other

Collaborators

  • Buddhist Tzu Chi General Hospital

Registry information

Official study title

Three Dimensional Motion Analysis of Daily Activities With Functional Insole in Parkinsonian Patients

Acronym: Parkinson

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jun 3, 2019
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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