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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treadmill Intervention 1: Rate Group | Experimental | 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. |
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| Magnitude treadmill group | Experimental | 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 |
|
| regular treadmill walking | Placebo Comparator | participants will walk at a comfortable self-selected pace on a treadmill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rate group | Behavioral | walking with a high cadence (steps per minute) |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. rate group: walking with a high cadence (steps per minute) |
| FG001 | 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 magnitude treadmill group |
| FG002 | Regular Treadmill Walking | participants will walk at a comfortable self-selected pace on a treadmill regular treadmill walking |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. rate group: walking with a high cadence (steps per minute) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale (0-4) | 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 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. rate group: walking with a high cadence (steps per minute) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle Strain | Musculoskeletal and connective tissue disorders | Mild Hamstring strain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Lasswell | WilfridLU | 9056992087 | lass3260@mylaurier.ca |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| magnitude treadmill group | Behavioral |
|
| regular treadmill walking | Behavioral |
|
| 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. |
| Adverse Event |
|
| BG001 |
| 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 magnitude treadmill group |
| BG002 | Regular Treadmill Walking | participants will walk at a comfortable self-selected pace on a treadmill regular treadmill walking |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Unified Parkinsons Disease Rating Scale-Motor Subsection (UPDRS III) | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 magnitude treadmill group |
| OG002 | Regular Treadmill Walking | participants will walk at a comfortable self-selected pace on a treadmill regular treadmill walking |
|
|
| Secondary | 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. | Not Posted | 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. |
| Secondary | 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. | Not Posted | 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. |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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 magnitude treadmill group | 0 | 16 | 2 | 16 |
| EG002 | Regular Treadmill Walking | participants will walk at a comfortable self-selected pace on a treadmill regular treadmill walking | 0 | 16 | 0 | 16 |
| back muscle tightness | Musculoskeletal and connective tissue disorders | minor back muscle discomfort leading the participant withdraw from the study |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |