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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: foot insole

• Registration Number: NCT03972241
• Lead Sponsor: Kwan-Hwa Lin

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-01-26
• Primary Completion: 2016-07
• Study Completion: 2017-12
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-30
• Last Update Submitted: 2019-05-30
• Study First Posted: 2019-06-03
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	foot insole	different interventions including foot insole or kinetic training

Primary Outcome Measures

Name	Time	Method
Ambulation	1 year	gait cycle

Secondary Outcome Measures

Name	Time	Method
Foot pressure	1 year	center of pressure
Coordination	1 year	Reaching movement
Spiral drawing	1 year	Figure plot

Trial Locations

Locations (1)

Tzu Chi University; 🇨🇳 Hualien City, Hualien County, Taiwan