Parkinson's Disease, Treadmill
Conditions
Keywords
treadmill, parkinson's, proprioception, cadence, step length, intrinsic feedback
Brief summary
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.
Interventions
BEHAVIORALrate group
walking with a high cadence (steps per minute)
BEHAVIORALmagnitude treadmill group
BEHAVIORALregular treadmill walking
Sponsors
Wilfrid Laurier University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) | 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
| Measure | Time frame | Description |
|---|---|---|
| Spatiotemporal Aspects of Gait | 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) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 13 |
| 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 | 13 |
| Regular Treadmill Walking participants will walk at a comfortable self-selected pace on a treadmill
regular treadmill walking | 13 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Treadmill Intervention 1: Rate Group | Magnitude Treadmill Group | Regular Treadmill Walking | Total |
|---|---|---|---|---|
| Age, Continuous | 63.77 years STANDARD_DEVIATION 7.01 | 70.46 years STANDARD_DEVIATION 9.52 | 66.31 years STANDARD_DEVIATION 9.07 | 66.85 years STANDARD_DEVIATION 8.83 |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 12 Participants | 34 Participants |
| Unified Parkinsons Disease Rating Scale-Motor Subsection (UPDRS III) | 23.35 units on a scale STANDARD_DEVIATION 8.13 | 22.96 units on a scale STANDARD_DEVIATION 6.93 | 22.46 units on a scale STANDARD_DEVIATION 8.64 | 22.92 units on a scale STANDARD_DEVIATION 7.73 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 2 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 |
Outcome results
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).
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treadmill Intervention 1: Rate Group | Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) | PRE | 23.35 units on a scale (0-4) | Standard Deviation 8.13 |
| Treadmill Intervention 1: Rate Group | Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) | POST | 18.81 units on a scale (0-4) | Standard Deviation 7.17 |
| Magnitude Treadmill Group | Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) | PRE | 22.96 units on a scale (0-4) | Standard Deviation 6.93 |
| Magnitude Treadmill Group | Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) | POST | 20.69 units on a scale (0-4) | Standard Deviation 8.39 |
| Regular Treadmill Walking | Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) | PRE | 22.46 units on a scale (0-4) | Standard Deviation 8.64 |
| Regular Treadmill Walking | Motor Section of the Unified Parkinson's Disease Rating Scale (UPDRS-III) | POST | 20.92 units on a scale (0-4) | Standard Deviation 6.14 |
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.
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.
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.
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.