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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Matthew Lasswell, Wilfrid Laurier University
ClinicalTrials.gov Identifier:
NCT01987557
First received: October 9, 2013
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 Intervention
Parkinson's Disease
Treadmill
Behavioral: rate group
Behavioral: magnitude treadmill group
Behavioral: regular treadmill walking

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Wilfrid Laurier University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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) [ 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. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Matthew Lasswell, Mr. Matthew Lasswell, Wilfrid Laurier University
ClinicalTrials.gov Identifier: NCT01987557     History of Changes
Other Study ID Numbers: MDRC
Study First Received: October 9, 2013
Last Updated: November 12, 2013
Health Authority: Wilfrid Laurier University Ethics Review Board: Canada

Keywords provided by Wilfrid Laurier University:
treadmill
parkinson's
proprioception
cadence
step length
intrinsic feedback

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 20, 2014