Parkinson DiseaseParkinsonNCT03972241
Strategy for Daily Activity Improvement in Patients With Parkinson's Disease
A study testing foot insole in people with Parkinson Disease, run by Kwan-Hwa Lin at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- foot insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stage II~IV of Hoehn and Yahr Staging of Parkinson's Disease and normal subjects, whose age between 40~75.
Who cannot join
- Brain injury or hemorrhage, including stroke, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Dimensional Motion Analysis of Daily Activities With Functional Insole in Parkinsonian Patients
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.
Read the 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
- Being tested
- foot insole
- Keywords
- Parkinson disease, Quality of life, Physical therapy, tremor, coordination, gait analysis
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
foot insoleDevice
Also called spiral drawing
arch support and toe extension
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | different interventions including foot insole or kinetic training Receives: Device: foot insole |
| control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulation
gait cycle
Measured: 1 year
Secondary outcomes (3)
Foot pressure
center of pressure
Measured: 1 year
Spiral drawing
Figure plot
Measured: 1 year
Coordination
Reaching movement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study startAug 2014
- Primary completionJul 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To compare between experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwan-Hwa Lin
- Sponsor type
- University, hospital or other
- Collaborators
- Buddhist Tzu Chi General Hospital
- Responsible party
- Sponsor-investigator, Kwan-Hwa Lin, Buddhist Tzu Chi General Hospital
- Investigators
- Kwan-Hwa Lin, PhD, Principal investigator, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972241
- Sponsor's protocol ID
- IRB103-43-A
- Other IDs
- IRB103-42-A, IRB 103-173-A
- Acronym
- Parkinson
- Status last verified
- May 2019
- First submitted
- 26 Jan 2015
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21474638Chen 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.
PubMed 19884813Myers 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.
PubMed 16300949Morris 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.
PubMed 11427288Lee 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.
PubMed 16571399
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Motion Analysis of Daily Activities With Functional Insole in Parkinsonian Patients
- ClinicalTrials.gov ID
- NCT03972241
- Acronym / sponsor ID
- Parkinson / IRB103-43-A
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Quality of life, Physical therapy, tremor, coordination, gait analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kwan-Hwa LinUniversity, hospital or other
- Collaborators
- Buddhist Tzu Chi General Hospital
- Study start
- Aug 2014 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- To compare between experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: foot insoledifferent interventions including foot insole or kinetic training |
| control | No intervention | –No intervention |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage II~IV of Hoehn and Yahr Staging of Parkinson's Disease and normal subjects, whose age between 40~75.
Key exclusion criteria (1 listed)
- Brain injury or hemorrhage, including stroke, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| foot insoleAlso: spiral drawingarch support and toe extension | Device | Intervention |
Primary outcome
Ambulation
Time frame: 1 year
gait cycle
3 secondary outcomes
Foot pressure
Time frame: 1 year
Spiral drawing
Time frame: 1 year
Coordination
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Background: PubMed 21474638Yen 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.
- Background: PubMed 19884813Chen 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.
- Background: PubMed 16300949Myers 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.
- Background: PubMed 11427288Morris 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.
- Background: PubMed 16571399Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwan-Hwa Lin, PhD principal investigator
Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing foot insole in people with Parkinson Disease, run by Kwan-Hwa Lin at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03972241, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.