Clinical trial NCT02809391: Orthotics and Parkinson's Disease: The Acute and Long-term Effects of Increased Somatosensory Feedback
Official title: Orthotics and Parkinson's Disease: The Acute and Long-term Effects of Increased Somatosensory Feedback
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Postural Balance
Gait
Foot Orthotic
Proprioception
Somatosensory
Lead sponsor: Wilfrid Laurier University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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, 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Change in Postural Sway during Static Stance
timeFrame: 6 weeks and 12 weeks post-baseline
measure: Change in Dynamic Balance, using the Berg Balance Scale, Timed Up and Go, and the Functional Gait Assessment
timeFrame: 6 weeks and 12 weeks post-baseline
Secondary outcomes:
measure: Change in Plantar Pressure Distribution
timeFrame: 6 weeks and 12 weeks post-baseline
measure: Change in Stride Length
timeFrame: 6 weeks and 12 weeks post-baseline
measure: Change in Stride Width
timeFrame: 6 weeks and 12 weeks post-baseline
measure: Change in Single Limb Support Time
timeFrame: 6 weeks and 12 weeks post-baseline
measure: Change in Walking Velocity
timeFrame: 6 weeks and 12 weeks post-baseline
measure: Change in Electromyography (EMG) Activity
timeFrame: 6 weeks and 12 weeks post-baseline
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Wilfrid Laurier University
state: Ontario
Study officials:
affiliation: Wilfrid Laurier University
name: Kelly Robb, B.A.Kin, C Ped. (C)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Gross 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.