Parkinson DiseaseNCT02809391
Orthotics and Parkinson's Disease: The Acute and Long-term Effects of Increased Somatosensory Feedback
A study testing Orthotics alone and Orthotics+textured top cover in people with Parkinson Disease, run by Wilfrid Laurier University at 1 site in Canada.
Trial summary
The purpose of this study is to increase clinical knowledge of the relationship between increased plantar sensory information and orthotics in a Parkinsonian gait. The objectives of this study are to determine if orthotics, with and without a textured top cover, can alter muscle activation, gait parameters, balance… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Orthotics alone and Orthotics+textured top cover
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Aug 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with idiopathic Parkinson' disease
- Exclusion Criteria: A pre-screening questionnaire will assess the following:
- peripheral neuropathy, vestibular concerns, cognitive impairment, severe arthritic conditions, or other conflicting medical conditions
- deep brain stimulation
- currently wearing orthotics, or previously worn in the last two years
- decreased plantar sole sensation
- requires the ability to walk 10m unassisted
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to increase clinical knowledge of the relationship between increased plantar sensory information and orthotics in a Parkinsonian gait. The objectives of this study are to determine if orthotics, with and without a textured top cover, can alter muscle activation, gait parameters, balance, functional mobility, and decrease fall risks in Parkinson's participants.
Read the detailed description
The purpose of this study is to increase clinical knowledge of the relationship between increased plantar sensory information and orthotics in a Parkinsonian gait. Observing gait parameters and muscle activation changes, in orthotics with and without a textured top cover, provides an increased understanding of conservative treatment options available to the Parkinson's population. It is hypothesized that balance and functional mobility in Parkinson's Disease (PD) patients will increase, while decreasing fall risks, when wearing both types of orthotics. Larger improvements are expected with the orthotics with a textured top cover, thus increasing plantar sensory feedback. Male and female participants, aged 55-75, with a diagnosis of idiopathic Parkinson's disease can participate in the study. Two types of orthotic design will be examined: 1) Customizable over-the-counter orthotics and 2) Customizable over-the-counter orthotics with a textured top cover. Five different assessments will be performed during three different testing sessions: 1) baseline testing; 2) 6-weeks post-baseline; and 3) 12-weeks post-baseline. The administered assessments include: 1) Static balance, double limb stance; 2) The Berg Balance Scale (BBS); 3) Timed Up and Go (TUG), 4) Functional Gait Assessment (FGA); and 5) Walking task.
- Conditions
- Parkinson Disease
- Being tested
- Orthotics alone, Orthotics+textured top cover
- Keywords
- Postural Balance, Gait, Foot Orthotic, Proprioception, Somatosensory
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthotics aloneDevice
Also called Sole thin sport orthotic
The sole thin sport orthotic will be heat moulded to participants footwear. A top cover will be used of similar cushioning thickness and durometer properties as the orthotics+texture intervention.
Orthotics+textured top coverDevice
Also called Sole thin sport orthotics with textured top cover
The sole thin sport orthotic will be heat moulded to participants footwear. A textured material will be used as the orthotic top cover in this intervention.
| Study group | Role | What they receive |
|---|---|---|
| Orthotic | Active comparator | Recruited participants will be asked to wear the customizable foot orthotic, from baseline testing to a follow-up at 6 weeks post-baseline. Outcome measures at 6 weeks will be compared to those at baseline. Receives: Device: Orthotics alone |
| Orthotic+Textured Top Cover | Active comparator | At 6 weeks post-baseline, participants will received a different orthotic which has a textured material used as its top cover. Testing at 6 weeks post-baseline will determine if acute changes occur as a result of wearing the orthotic with textured top cover. Testing at 12 weeks post-baseline will determine if long-term changes occur as a result of the orthotic with textured top cover. Receives: Device: Orthotics+textured top cover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postural Sway during Static Stance
Static balance will be measured by the amount of postural sway in both the medio-lateral (ML) and antero-posterior (AP) directions. Participants will be asked to stand, without movement, on the pressure platform for 2 minutes. The force platform will measure the amount of spatio-temporal firing patterns from the sensory afferents in the plantar surface of participant's feet. Secondly, the IRED markers placed on participants clothing, will measure the center of mass (COM) changes in relation to the base of support (BOS). An improvement in the location of the COM in relation to the BOS suggests an improvement in balance, resulting from increased cutaneous sensation from the textured material.
Measured: 6 weeks and 12 weeks post-baseline
Change in Dynamic Balance, using the Berg Balance Scale, Timed Up and Go, and the Functional Gait Assessment
Improvements in dynamic balance and postural stability will be defined by score improvements on the BBS, TUG, and FGA assessments. Furthermore, plantar pressure changes will be recorded during the walking task to determine if simple changes in top cover design can alter the cutaneous information from the plantar surface of the foot. Observations will be made of the plantar pressure distribution changes between the orthotic, with and without a textured top cover, in comparison to participants walking patterns with footwear alone.
Measured: 6 weeks and 12 weeks post-baseline
Secondary outcomes (6)
Change in Plantar Pressure Distribution
Force platform data will detail participant's plantar pressure distribution. Changes in plantar pressures will be recorded at 6-weeks and 12-weeks post-baseline. Pressure patterns can visually demonstrate the precise location of pressure changes on the plantar sole of the foot. Secondly, peak forces and increased load can be isolated to specific areas of the plantar sole of the foot, in relation to the total stance phase of the gait cycle (heel strike, midstance, forefoot load, and toe-off).
Measured: 6 weeks and 12 weeks post-baseline
Change in Stride Length
Force platform data will be recorded for each participant. The anterior-posterior displacement of the ankle markers will be used to determine stride length, defined as the distance between heel strikes of the same limb.
Measured: 6 weeks and 12 weeks post-baseline
Change in Stride Width
Force platform data will be recorded for each participant. Platform data and marker placement on participants will determine stride width, also known as base of gait, which is defined as the lateral distance between midlines of each foot.
Measured: 6 weeks and 12 weeks post-baseline
Change in Single Limb Support Time
Force platform data will be recorded for each participant. Single limb support time is the duration of weight bearing, when only 1 limb is on contact with the ground. The force platform will record the duration of time a participant spends weight bearing on each limb.
Measured: 6 weeks and 12 weeks post-baseline
Change in Walking Velocity
Walking velocity, or speed of gait, will be recoded by the force platform data.
Measured: 6 weeks and 12 weeks post-baseline
Change in Electromyography (EMG) Activity
Muscle activity will be measured through EMG recordings of the tibialis anterior, peroneus longus, and gastrochnemius musculature. Secondly, changes in muscle activity will be observed in the orthotics alone compared to the textured top cover condition. The study will evaluate if the length, timing, and magnitude of the tibialis anterior, peroneus longus, and gastrochnemius properties altered with the use of orthotics, with and without a textured top cover, compared to footwear alone.
EMG data analysis will be isolated to the stance phase of gait for each of the three muscles. The time of muscle onset and offset will be recorded within the stance phase. This will determine the location and total percentage of the stance phase each muscle activity occupied. The length of activation, the muscle's specific start and stop time of activation, and magnitude of activation will be recorded.
Measured: 6 weeks and 12 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Robb, Wilfrid Laurier University
- Investigators
- Kelly Robb, B.A.Kin, C Ped. (C), Principal investigator, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809391
- Sponsor's protocol ID
- KR_POG
- Status last verified
- Jun 2016
- First submitted
- 13 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Jenkins ME, Almeida QJ, Spaulding SJ, van Oostveen RB, Holmes JD, Johnson AM, Perry SD. Plantar cutaneous sensory stimulation improves single-limb support time, and EMG activation patterns among individuals with Parkinson's disease. Parkinsonism Relat Disord. 2009 Nov;15(9):697-702. doi: 10.1016/j.parkreldis.2009.04.004. Epub 2009 May 20.
PubMed 19467910Gross MT, Mercer VS, Lin FC. Effects of foot orthoses on balance in older adults. J Orthop Sports Phys Ther. 2012 Jul;42(7):649-57. doi: 10.2519/jospt.2012.3944. Epub 2012 Jan 25.
PubMed 22282317
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthotics and Parkinson's Disease: The Acute and Long-term Effects of Increased Somatosensory Feedback
- ClinicalTrials.gov ID
- NCT02809391
- Acronym / sponsor ID
- KR_POG
- Conditions
- Parkinson Disease
- Keywords
- Postural Balance, Gait, Foot Orthotic, Proprioception, Somatosensory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- 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 purpose of this study is to increase clinical knowledge of the relationship between increased plantar sensory information and orthotics in a Parkinsonian gait. The objectives of this study are to determine if orthotics, with and without a textured top cover, can alter muscle activation, gait parameters, balance, functional mobility, and decrease fall risks in Parkinson's participants.
Detailed description
The purpose of this study is to increase clinical knowledge of the relationship between increased plantar sensory information and orthotics in a Parkinsonian gait. Observing gait parameters and muscle activation changes, in orthotics with and without a textured top cover, provides an increased understanding of conservative treatment options available to the Parkinson's population. It is hypothesized that balance and functional mobility in Parkinson's Disease (PD) patients will increase, while decreasing fall risks, when wearing both types of orthotics. Larger improvements are expected with the orthotics with a textured top cover, thus increasing plantar sensory feedback. Male and female participants, aged 55-75, with a diagnosis of idiopathic Parkinson's disease can participate in the study. Two types of orthotic design will be examined: 1) Customizable over-the-counter orthotics and 2) Customizable over-the-counter orthotics with a textured top cover. Five different assessments will be performed during three different testing sessions: 1) baseline testing; 2) 6-weeks post-baseline; and 3) 12-weeks post-baseline. The administered assessments include: 1) Static balance, double limb stance; 2) The Berg Balance Scale (BBS); 3) Timed Up and Go (TUG), 4) Functional Gait Assessment (FGA); and 5) Walking task.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthotic | Active comparator | Device: Orthotics aloneRecruited participants will be asked to wear the customizable foot orthotic, from baseline testing to a follow-up at 6 weeks post-baseline. Outcome measures at 6 weeks will be compared to those at baseline. |
| Orthotic+Textured Top Cover | Active comparator | Device: Orthotics+textured top coverAt 6 weeks post-baseline, participants will received a different orthotic which has a textured material used as its top cover. Testing at 6 weeks post-baseline will determine if acute changes occur as a result of wearing the orthotic with textured top cover. Testing at 12 weeks post-baseline will determine if long-term changes occur as a result of the orthotic with textured top cover. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosed with idiopathic Parkinson' disease
- peripheral neuropathy, vestibular concerns, cognitive impairment, severe arthritic conditions, or other conflicting medical conditions
- deep brain stimulation
- currently wearing orthotics, or previously worn in the last two years
- decreased plantar sole sensation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Orthotics aloneAlso: Sole thin sport orthoticThe sole thin sport orthotic will be heat moulded to participants footwear. A top cover will be used of similar cushioning thickness and durometer properties as the orthotics+texture intervention. | Device | Orthotic |
| Orthotics+textured top coverAlso: Sole thin sport orthotics with textured top coverThe sole thin sport orthotic will be heat moulded to participants footwear. A textured material will be used as the orthotic top cover in this intervention. | Device | Orthotic+Textured Top Cover |
Primary outcome
Change in Postural Sway during Static Stance
Time frame: 6 weeks and 12 weeks post-baseline
Static balance will be measured by the amount of postural sway in both the medio-lateral (ML) and antero-posterior (AP) directions. Participants will be asked to stand, without movement, on the pressure platform for 2 minutes. The force platform will measure the amount of spatio-temporal firing patterns from the sensory afferents in the plantar surface of participant's feet. Secondly, the IRED markers placed on participants clothing, will measure the center of mass (COM) changes in relation to the base of support (BOS). An improvement in the location of the COM in relation to the BOS suggests an improvement in balance, resulting from increased cutaneous sensation from the textured material.
Change in Dynamic Balance, using the Berg Balance Scale, Timed Up and Go, and the Functional Gait Assessment
Time frame: 6 weeks and 12 weeks post-baseline
Improvements in dynamic balance and postural stability will be defined by score improvements on the BBS, TUG, and FGA assessments. Furthermore, plantar pressure changes will be recorded during the walking task to determine if simple changes in top cover design can alter the cutaneous information from the plantar surface of the foot. Observations will be made of the plantar pressure distribution changes between the orthotic, with and without a textured top cover, in comparison to participants walking patterns with footwear alone.
6 secondary outcomes
Change in Plantar Pressure Distribution
Time frame: 6 weeks and 12 weeks post-baseline
Change in Stride Length
Time frame: 6 weeks and 12 weeks post-baseline
Change in Stride Width
Time frame: 6 weeks and 12 weeks post-baseline
Change in Single Limb Support Time
Time frame: 6 weeks and 12 weeks post-baseline
Change in Walking Velocity
Time frame: 6 weeks and 12 weeks post-baseline
Change in Electromyography (EMG) Activity
Time frame: 6 weeks and 12 weeks post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- Background: PubMed 19467910Jenkins ME, Almeida QJ, Spaulding SJ, van Oostveen RB, Holmes JD, Johnson AM, Perry SD. Plantar cutaneous sensory stimulation improves single-limb support time, and EMG activation patterns among individuals with Parkinson's disease. Parkinsonism Relat Disord. 2009 Nov;15(9):697-702. doi: 10.1016/j.parkreldis.2009.04.004. Epub 2009 May 20.
- Background: PubMed 22282317Gross MT, Mercer VS, Lin FC. Effects of foot orthoses on balance in older adults. J Orthop Sports Phys Ther. 2012 Jul;42(7):649-57. doi: 10.2519/jospt.2012.3944. Epub 2012 Jan 25.
- 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.
Kelly Robb, B.A.Kin, C Ped. (C) principal investigator
Wilfrid Laurier 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 Orthotics alone and Orthotics+textured top cover in people with Parkinson Disease, run by Wilfrid Laurier University at 1 site in Canada.
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 7 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Jun 2016. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Robb, B.A.Kin, C Ped. (C) ((519) 884-1970 ext. 3298, robb8660@mylaurier.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postural Sway during Static Stance (time frame: 6 weeks and 12 weeks post-baseline). The study lists 2 primary outcomes in all. 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 NCT02809391, which also lists 2 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 22 Jun 2016.