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

NCT03972241 | Completed DMC

• 3 other identifiers: IRB103-43-AIRB103-42-AIRB 103-173-A
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Quality of life; Physical therapy; tremor; coordination; gait analysis

Outcome Measures

Primary Outcomes (1)

• Ambulation

  gait cycle

  1 year

Secondary Outcomes (3)

• Foot pressure

  1 year

• Spiral drawing

  1 year

• Coordination

  1 year

Study Arms (2)

Intervention

EXPERIMENTAL

different interventions including foot insole or kinetic training

Device: foot insole

control

NO INTERVENTION

No intervention

Interventions

foot insole DEVICE

arch support and toe extension

Also known as: spiral drawing

Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Brain injury or hemorrhage, including stroke, etc.

Sponsors & Collaborators

• Kwan-Hwa Lin: lead
• Buddhist Tzu Chi General Hospital: collaborator

Study Sites (1)

Tzu Chi University

Hualien City, Hualien County, 97004, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 21474638 BACKGROUND

• 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.

  PMID: 19884813 BACKGROUND

• 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.

  PMID: 16300949 BACKGROUND

• 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.

  PMID: 11427288 BACKGROUND

• 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.

  PMID: 16571399 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Tremor

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Kwan-Hwa Lin, PhD

  Tzu Chi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Tzu Chi University

Model Details: To compare between experimental and control groups.

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: June 3, 2019
• Study Start: August 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2017
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)