Amplitude and Rate of Intrinsic Feedback During Treadmill Training for Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT01987557|
Recruitment Status : Completed
First Posted : November 19, 2013
Results First Posted : June 17, 2015
Last Update Posted : June 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Treadmill||Behavioral: rate group Behavioral: magnitude treadmill group Behavioral: regular treadmill walking||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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|
- 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).
- 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.
- 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.