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

NCT ID: NCT03972241

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

different interventions including foot insole or kinetic training

Group Type: EXPERIMENTAL

foot insole

Intervention Type: DEVICE

arch support and toe extension

control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

foot insole

arch support and toe extension

Intervention Type: DEVICE

Other Intervention Names

spiral drawing

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: collaborator

Kwan-Hwa Lin

OTHER

Sponsor Role: lead

Responsible Party

Kwan-Hwa Lin

Department of Tzu Chi University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kwan-Hwa Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Tzu Chi University

Locations

Tzu Chi University

Hualien City, Hualien County, Taiwan

Countries

Taiwan

References

Yen CY, Lin KH, Hu MH, Wu RM, Lu TW, Lin CH. Effects of virtual reality-augmented balance training on sensory organization and attentional demand for postural control in people with Parkinson disease: a randomized controlled trial. Phys Ther. 2011 Jun;91(6):862-74. doi: 10.2522/ptj.20100050. Epub 2011 Apr 7.

Reference Type: BACKGROUND

PMID: 21474638 (View on PubMed)

Chen CH, Lin KH, Lu TW, Chai HM, Chen HL, Tang PF, Hu MH. Immediate effect of lateral-wedged insole on stance and ambulation after stroke. Am J Phys Med Rehabil. 2010 Jan;89(1):48-55. doi: 10.1097/PHM.0b013e3181c1ea8a.

Reference Type: BACKGROUND

PMID: 19884813 (View on PubMed)

Myers KA, Long JT, Klein JP, Wertsch JJ, Janisse D, Harris GF. Biomechanical implications of the negative heel rocker sole shoe: gait kinematics and kinetics. Gait Posture. 2006 Nov;24(3):323-30. doi: 10.1016/j.gaitpost.2005.10.006. Epub 2005 Nov 21.

Reference Type: BACKGROUND

PMID: 16300949 (View on PubMed)

Morris ME, Huxham F, McGinley J, Dodd K, Iansek R. The biomechanics and motor control of gait in Parkinson disease. Clin Biomech (Bristol). 2001 Jul;16(6):459-70. doi: 10.1016/s0268-0033(01)00035-3.

Reference Type: BACKGROUND

PMID: 11427288 (View on PubMed)

Lee HJ, Chou LS. Detection of gait instability using the center of mass and center of pressure inclination angles. Arch Phys Med Rehabil. 2006 Apr;87(4):569-75. doi: 10.1016/j.apmr.2005.11.033.

Reference Type: BACKGROUND

PMID: 16571399 (View on PubMed)

Other Identifiers

IRB103-42-A

Identifier Type: OTHER

Identifier Source: secondary_id

IRB 103-173-A

Identifier Type: OTHER

Identifier Source: secondary_id

IRB103-43-A

Identifier Type: -

Identifier Source: org_study_id