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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Orthotics alone
Orthotics+textured top cover
Sponsored by
Wilfrid Laurier University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Postural Balance, Gait, Foot Orthotic, Proprioception, Somatosensory

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wilfrid Laurier University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Orthotic

Orthotic+Textured Top Cover

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
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.
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.
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.
Change in Walking Velocity
Walking velocity, or speed of gait, will be recoded by the force platform data.
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.

Full Information

First Posted
June 13, 2016
Last Updated
June 18, 2016
Sponsor
Wilfrid Laurier University
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1. Study Identification

Unique Protocol Identification Number
NCT02809391
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wilfrid Laurier University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Postural Balance, Gait, Foot Orthotic, Proprioception, Somatosensory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orthotic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Orthotic+Textured Top Cover
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Orthotics alone
Other Intervention Name(s)
Sole thin sport orthotic
Intervention Description
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
Intervention Name(s)
Orthotics+textured top cover
Other Intervention Name(s)
Sole thin sport orthotics with textured top cover
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Postural Sway during Static Stance
Description
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.
Time Frame
6 weeks and 12 weeks post-baseline
Title
Change in Dynamic Balance, using the Berg Balance Scale, Timed Up and Go, and the Functional Gait Assessment
Description
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.
Time Frame
6 weeks and 12 weeks post-baseline
Secondary Outcome Measure Information:
Title
Change in Plantar Pressure Distribution
Description
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).
Time Frame
6 weeks and 12 weeks post-baseline
Title
Change in Stride Length
Description
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.
Time Frame
6 weeks and 12 weeks post-baseline
Title
Change in Stride Width
Description
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.
Time Frame
6 weeks and 12 weeks post-baseline
Title
Change in Single Limb Support Time
Description
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.
Time Frame
6 weeks and 12 weeks post-baseline
Title
Change in Walking Velocity
Description
Walking velocity, or speed of gait, will be recoded by the force platform data.
Time Frame
6 weeks and 12 weeks post-baseline
Title
Change in Electromyography (EMG) Activity
Description
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.
Time Frame
6 weeks and 12 weeks post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Robb, B.A.Kin, C Ped. (C)
Phone
(519) 884-1970
Ext
3298
Email
robb8660@mylaurier.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Perry, PhD
Phone
519-884-0710
Ext
4215
Email
sperry@wlu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Robb, B.A.Kin, C Ped. (C)
Organizational Affiliation
Wilfrid Laurier University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilfrid Laurier University
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3C5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19467910
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.
Results Reference
background
PubMed Identifier
22282317
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.
Results Reference
background

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

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