NCT02809391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

June 22, 2016

Status Verified

June 1, 2016

Enrollment Period

6 months

First QC Date

June 13, 2016

Last Update Submit

June 18, 2016

Conditions

Parkinson Disease

Keywords

Postural BalanceGaitFoot OrthoticProprioceptionSomatosensory

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 weeks and 12 weeks post-baseline

Secondary Outcomes (6)

  • Change in Plantar Pressure Distribution

    6 weeks and 12 weeks post-baseline

  • Change in Stride Length

    6 weeks and 12 weeks post-baseline

  • Change in Stride Width

    6 weeks and 12 weeks post-baseline

  • Change in Single Limb Support Time

    6 weeks and 12 weeks post-baseline

  • Change in Walking Velocity

    6 weeks and 12 weeks post-baseline

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Device: Orthotics+textured top cover

Interventions

Orthotics aloneDEVICE

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.

Also known as: Sole thin sport orthotic
Orthotic
Orthotics+textured top coverDEVICE

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.

Also known as: Sole thin sport orthotics with textured top cover
Orthotic+Textured Top Cover

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with idiopathic Parkinson' disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilfrid Laurier University

Waterloo, Ontario, N2L 3C5, Canada

Location

Related Publications (2)

  • 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.

    PMID: 19467910BACKGROUND

  • 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.

    PMID: 22282317BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Braces

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Kelly Robb, B.A.Kin, C Ped. (C)

    Wilfrid Laurier University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

(519) 884-1970robb8660@mylaurier.ca

Stephen Perry, PhD

CONTACT

519-884-0710sperry@wlu.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master's student

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 22, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

August 1, 2017

Last Updated

June 22, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)