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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01987557
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : June 17, 2015
Last Update Posted : June 17, 2015
Information provided by (Responsible Party):
Matthew Lasswell, Wilfrid Laurier University

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Treadmill Behavioral: rate group Behavioral: magnitude treadmill group Behavioral: regular treadmill walking Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Therapeutic Contributions of Somatosensory Feedback During Exercise in Parkinson's Disease; A Randomized, Controlled Trial.
Study Start Date : October 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treadmill Intervention 1: Rate Group
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.
Behavioral: rate group
walking with a high cadence (steps per minute)

Experimental: Magnitude treadmill group
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
Behavioral: magnitude treadmill group
Placebo Comparator: regular treadmill walking
participants will walk at a comfortable self-selected pace on a treadmill
Behavioral: regular treadmill walking

Primary Outcome Measures :
  1. Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) [ 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 ]

    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 :
  1. Spatiotemporal Aspects of Gait [ 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. ]

    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.

  2. Static Posturography (Balance/Postural Control) [ 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. ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: Matthew Lasswell, Mr. Matthew Lasswell, Wilfrid Laurier University Identifier: NCT01987557    
Other Study ID Numbers: MDRC
First Posted: November 19, 2013    Key Record Dates
Results First Posted: June 17, 2015
Last Update Posted: June 17, 2015
Last Verified: June 2015
Keywords provided by Matthew Lasswell, Wilfrid Laurier University:
step length
intrinsic feedback
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases