Orthotics and Parkinson's Disease: The Acute and Long-term Effects of Increased Somatosensory Feedback

NCT ID: NCT02809391

Last Updated: 2016-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-08-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orthotic

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.

Group Type: ACTIVE_COMPARATOR

Orthotics alone

Intervention Type: DEVICE

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.

Orthotic+Textured Top Cover

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.

Group Type: ACTIVE_COMPARATOR

Orthotics+textured top cover

Intervention Type: DEVICE

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.

Interventions

Orthotics alone

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.

Intervention Type: DEVICE

Orthotics+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.

Intervention Type: DEVICE

Other Intervention Names

Sole thin sport orthotic; Sole thin sport orthotics with textured top cover

Eligibility Criteria

Inclusion Criteria

• diagnosed with idiopathic Parkinson' disease

Exclusion Criteria

• 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wilfrid Laurier University

OTHER

Sponsor Role: lead

Responsible Party

Kelly Robb

master's student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelly Robb, B.A.Kin, C Ped. (C)

Role: PRINCIPAL_INVESTIGATOR

Wilfrid Laurier University

Locations

Wilfrid Laurier University

Waterloo, Ontario, Canada

Countries

Canada

Central Contacts

Kelly Robb, B.A.Kin, C Ped. (C)

Role: CONTACT

robb8660@mylaurier.ca

(519) 884-1970 ext. 3298

Stephen Perry, PhD

Role: CONTACT

sperry@wlu.ca

519-884-0710 ext. 4215

References

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.

Reference Type: BACKGROUND

PMID: 19467910 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22282317 (View on PubMed)

Other Identifiers

KR_POG

Identifier Type: -

Identifier Source: org_study_id