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

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson's Disease, Treadmill

Intervention / Treatment
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* Behavioral: rate group
* Behavioral: magnitude treadmill group
* Behavioral: regular treadmill walking


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill Intervention 1: Rate Group<br>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<br>* walking with a high cadence (steps per minute)<br>|
| Experimental: Magnitude treadmill group<br>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<br> <br> |
| Placebo Comparator: regular treadmill walking<br>participants will walk at a comfortable self-selected pace on a treadmill | Behavioral: regular treadmill walking<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 
| 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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treadmill, parkinson's, proprioception, cadence, step length, intrinsic feedback