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Completed

NCT Number: NCT01987557

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies Treadmill

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rate group

Behavioral

walking with a high cadence (steps per minute)

magnitude treadmill group

Behavioral

regular treadmill walking

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wilfrid Laurier University

Other

Registry information

Official study title

The Therapeutic Contributions of Somatosensory Feedback During Exercise in Parkinson's Disease; A Randomized, Controlled Trial.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 19, 2013
Registry last updated
Jun 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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