Clinical trial NCT03972241: Strategy for Daily Activity Improvement in Patients With Parkinson's Disease
Official title: Three Dimensional Motion Analysis of Daily Activities With Functional Insole in Parkinsonian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson disease
Quality of life
Physical therapy
tremor
coordination
gait analysis
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
Collaborators: name: Buddhist Tzu Chi General Hospital
First posted: 2019-06-03
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To compare between experimental and control groups.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Ambulation
timeFrame: 1 year
Secondary outcomes:
measure: Foot pressure
timeFrame: 1 year
measure: Spiral drawing
timeFrame: 1 year
measure: Coordination
timeFrame: 1 year
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Tzu Chi University
state: Hualien County
Study officials:
affiliation: Tzu Chi University
name: Kwan-Hwa Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.