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Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease

Primary Purpose

Parkinson's Disease, Treadmill

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rate group
magnitude treadmill group
regular treadmill walking
Sponsored by
Wilfrid Laurier University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring treadmill, parkinson's, proprioception, cadence, step length, intrinsic feedback

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of Parkinson's disease
  • must be able to walk unassisted for 10 metres

Exclusion Criteria:

  • cardiovascular disease/history of stroke
  • Dementia
  • lower body injury that would be worsened by repetitive walking

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Treadmill Intervention 1: Rate Group

    Magnitude treadmill group

    regular treadmill walking

    Arm Description

    Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.

    In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs

    participants will walk at a comfortable self-selected pace on a treadmill

    Outcomes

    Primary Outcome Measures

    Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)
    A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure. The UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment).

    Secondary Outcome Measures

    Spatiotemporal Aspects of Gait
    Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined. Quantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis. Spotters are always present to ensure safety during this assessment.
    Static Posturography (Balance/Postural Control)
    A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.

    Full Information

    First Posted
    October 9, 2013
    Last Updated
    June 12, 2015
    Sponsor
    Wilfrid Laurier University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01987557
    Brief Title
    Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease
    Official Title
    The Therapeutic Contributions of Somatosensory Feedback During Exercise in Parkinson's Disease; A Randomized, Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Treadmill training has been shown to be beneficial for reducing motor symptoms of Parkinson's disease (PD). The mechanisms for the therapeutic effects of treadmill training remain unknown. However, specific types of intrinsic feedback generated from muscle spindles (detect changes in length of muscle) and golgi tendon organs (detect muscle force) seem to be an important factor for achieving the reductions in motor scores. This study will compare a treadmill program that generates a high rate of intrinsic feedback to a treadmill program focused on generating a high magnitude of intrinsic feedback.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease, Treadmill
    Keywords
    treadmill, parkinson's, proprioception, cadence, step length, intrinsic feedback

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    48 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treadmill Intervention 1: Rate Group
    Arm Type
    Experimental
    Arm Description
    Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.
    Arm Title
    Magnitude treadmill group
    Arm Type
    Experimental
    Arm Description
    In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs
    Arm Title
    regular treadmill walking
    Arm Type
    Placebo Comparator
    Arm Description
    participants will walk at a comfortable self-selected pace on a treadmill
    Intervention Type
    Behavioral
    Intervention Name(s)
    rate group
    Intervention Description
    walking with a high cadence (steps per minute)
    Intervention Type
    Behavioral
    Intervention Name(s)
    magnitude treadmill group
    Intervention Type
    Behavioral
    Intervention Name(s)
    regular treadmill walking
    Primary Outcome Measure Information:
    Title
    Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III)
    Description
    A measure of the motor symptom severity within Parkinsons. UPDRS III is a qualitative assessment performed by a trained clinician. Specifically, a change in UPDRS III from pre to post is the main outcome measure. The UPDRS-III score is a summation of 27 tasks that are scored from 0-4. 0 meaning no impairment, and 4 representing extreme impairment, inability to complete task. Possible scores on the UPDRS-III range from 0 (no impairment) to 108 (extreme impairment).
    Time Frame
    Pre assessments are conducted in the week prior to the treadmill program. Post are conducted during the week immediately following the program. Changes after the 6 week treadmill program are being examined
    Secondary Outcome Measure Information:
    Title
    Spatiotemporal Aspects of Gait
    Description
    Participants will walk on a pressure sensitive GAITRite carpet (Sparta, NJ), at both comfortable and fast paced walking speeds. Changes in gait characteristics from pre to post are what is being examined. Quantitative measures of gait such as step time, step length, walking velocity, and others will be used in the analysis. Spotters are always present to ensure safety during this assessment.
    Time Frame
    pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.
    Title
    Static Posturography (Balance/Postural Control)
    Description
    A Balance SD system from BIODEX (Shirley, NY) will be used to assess postural control. Changes from pre to post are what is being examined.
    Time Frame
    pre test occurs within the week prior to the start of the treadmill training program. Post testing will occur during the week immediately following the 6 week treadmill training program.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: diagnosis of Parkinson's disease must be able to walk unassisted for 10 metres Exclusion Criteria: cardiovascular disease/history of stroke Dementia lower body injury that would be worsened by repetitive walking

    12. IPD Sharing Statement

    Learn more about this trial

    Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease

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