NCT02809391

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Wilfrid Laurier University · Academic / Other
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-01-01
• Completion: 2017-08-01
• First posted: 2016-06-22
• Last updated: 2016-06-22

Locations

1 site across 1 country: Canada