Parkinson Disease
Conditions
Keywords
Parkinson, Exoskeleton, Honda, Walking Assist, Walking, Gait, Mobility, Rehabilitation, Physical Therapy
Brief summary
This Phase II randomized controlled trial proposes to examine the impact of long-term use of a novel light-weight and wearable assistive robotic device, called the Honda Walking Assist (HWA) device, to improve mobility in the home and community in individuals with mild to moderate Parkinson's disease (PD). Specific aims of the project are to: 1) determine the short-term impact of mechanical gait assistance on efficiency and ease of walking in individuals with PD, and 2) determine the effect of long-term HWA device usage on the ease and ability to walk unassisted in the home and community in individuals with PD.
Detailed description
Difficulties with walking in people with Parkinson's disease contribute to injurious falls and decreased quality of life. The Honda Walking Assist (HWA) robotic device is designed to assist individuals with gait impairments to take longer strides and walk faster. This study will investigate the impact of HWA usage on mobility in the home and community in individuals with PD. It will also examine feasibility and safety of HWA usage in the PD population. Specific Aim 1: Determine the short-term impact of mechanical gait assistance on efficiency and ease of walking in individuals with PD. With disease progression, individuals with PD develop gait impairments (e.g., slower gait velocity, shorter step lengths, increased step-to-step variability, and freezing of gait), that interfere with their abilities to perform daily living tasks and participate in work, home, and social activities and predispose them to falls. The investigators hypothesize that wearing the HWA device will improve gait efficiency, gait parameters, and perceived ease of walking in individuals with PD compared to unassisted walking over a one session period. Specific Aim 2: Determine the effect of long-term HWA device usage on the ease and ability to walk unassisted in the home and community in individuals with PD. Angular sensors embedded in the HWA monitor the cadence, angular velocity, and degree of hip extension and flexion of the device user. When the user initiates walking, the HWA automatically adjusts leg movements to reach target walk ratios (step length/cadence) by increasing the amount of hip flexion and/or extension using power supplied by the device. Thus, the HWA applies continuous, step-by-step cueing to individuals with PD to take bigger and more symmetrical steps, thereby producing a faster and more efficient walking pattern. By wearing the HWA device over an extended period of time, individuals with PD will repetitively practice walking with a more normal gait pattern, possibly driving neuroplastic changes that will translate to improve unassisted walking. The investigators hypothesize that an 8-week intervention of HWA device usage will improve gait efficiency, gait parameters, perceived ease of walking, self-confidence, and daily physical activity in the home and community in individuals with PD with and without the use of the device.
Interventions
DEVICETraining with HWA device
Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.
OTHERUsual Care
The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
Honda Research and Development Americas
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of idiopathic Parkinson's disease * Age 50-80 years * Able to ambulate without assistance (Hoehn & Yahr stages 1-3) * On stable doses of Parkinson's medications for at least 4 weeks prior to the study.
Exclusion criteria
* Presence of other significant cardiac, neurological or orthopedic problems that affect gait * Weight more than 220 pounds and height greater than 6'8 * Electronic medical devices embedded in the body * Participating in any physical therapy * Inability to understand instructions required by the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gait Velocity | 8 weeks | Walking speed in meters per second |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stride Length | 8 weeks | Stride length in centimeters |
| Double Support Time | 8 weeks | Double support time in seconds |
| Swing Time - Right Leg | 8 weeks | Swing time in seconds of right leg |
| Swing Time - Left Leg | 8 weeks | Swing time in seconds of left leg |
| Double Support Time Coefficient of Variation | 8 weeks | The double support time coefficient of variation was calculated by first calculating the mean and SD of the double support time for each of the participants. The calculation of the coefficient of variation were done by taking the standard deviations and dividing them by the mean. Thus calculation of the double support time coefficient of variation required multiple measures for each participant. After calculating the double support time coefficients of variation for each participant, we then calculated the mean and SD of the double support time coefficients of variation. This explains the data value with the measure of central tendency reported in the data table. |
| Swing Time Coefficient of Variation of Right Leg | 8 weeks | The swing time coefficient of variation of right leg was calculated by first calculating the mean and SD of the swing time of the right leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of right leg coefficient of variation required multiple measures for each participant. After calculating the swing time of right leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the right leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table. |
| 6-Minute Walk Test | 8 weeks | Distance walked in 6 minutes, reported in meters |
| Stride Length Coefficient of Variation | 8 weeks | The stride length coefficient of variation was calculated by first calculating the mean and SD of the stride length for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the stride length coefficient of variation required multiple measures for each participant. After calculating the stride length coefficients of variation for each participant, we then calculated the mean and SD of the stride length coefficients of variation. This explains the data value with the measure of central tendency reported in the data table. |
| Participants' Perceived Ease of Walking | 8 weeks | Indicated on a visual analog scale (line with demarcations of 0-10 spaced evenly and with anchors Not at all easy at 0 on the left end, moderately easy at 5, and Extremely easy at 10 on the right end). Participants are asked to rate where on line it indicates how easy it felt for them to walk during the six minute walk test. |
| Self-Efficacy for Measuring Chronic Disease 6-Item Scale | 8 weeks | Questionnaire to measure participants' confidence (I.e., self-efficacy) in performing daily activities. The score for the scale is the mean of the 6 items with a range of possible scores from 1 to 10. Higher number (10) indicates higher self-efficacy. |
| Freezing of Gait Questionnaire | 8 weeks | The Freezing of Gait Questionnaire assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects. Six items are scored on 0-4 scale for a total score range of 0-24, with higher scores indicating worse outcomes. |
| Number of Participants With Falls | 8 weeks | Number of participants who recorded falls in a log during the 8-week intervention |
| Swing Time Coefficient of Variation of Left Leg | 8 weeks | The swing time coefficient of variation of left leg was calculated by first calculating the mean and SD of the swing time of the left leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of left leg coefficient of variation required multiple measures for each participant. After calculating the swing time of left leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the left leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Walking Training With the HWA Device Training with HWA device
Training with HWA device: Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed. | 23 |
| Usual Care Usual Care
Usual Care: The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period. | 22 |
| Total | 45 |
Baseline characteristics
| Characteristic | Usual Care | Total | Walking Training With the HWA Device |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 17 Participants | 36 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 9 Participants | 4 Participants |
| Age, Continuous | 72 years | 72 years | 72 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 22 participants | 45 participants | 23 participants |
| Sex: Female, Male Female | 2 Participants | 12 Participants | 10 Participants |
| Sex: Female, Male Male | 20 Participants | 33 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 |
| other Total, other adverse events | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 |
Outcome results
Primary
Gait Velocity
Walking speed in meters per second
Time frame: 8 weeks
Population: Missing gait velocity data for one participant in the Training group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Gait Velocity | 1.25 Meters per second | Standard Deviation 0.3 |
| Usual Care | Gait Velocity | 1.25 Meters per second | Standard Deviation 0.33 |
Secondary
6-Minute Walk Test
Distance walked in 6 minutes, reported in meters
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | 6-Minute Walk Test | 416.93 Meters | Standard Deviation 124.35 |
| Usual Care | 6-Minute Walk Test | 426.92 Meters | Standard Deviation 125 |
Secondary
Double Support Time
Double support time in seconds
Time frame: 8 weeks
Population: Missing data for one person in the training group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Double Support Time | 18.01 Seconds | Standard Deviation 5.56 |
| Usual Care | Double Support Time | 16.77 Seconds | Standard Deviation 4.38 |
Secondary
Double Support Time Coefficient of Variation
The double support time coefficient of variation was calculated by first calculating the mean and SD of the double support time for each of the participants. The calculation of the coefficient of variation were done by taking the standard deviations and dividing them by the mean. Thus calculation of the double support time coefficient of variation required multiple measures for each participant. After calculating the double support time coefficients of variation for each participant, we then calculated the mean and SD of the double support time coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.
Time frame: 8 weeks
Population: Missing data for one person in the training group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Double Support Time Coefficient of Variation | 0.20 Coefficient of variation | Standard Deviation 0.09 |
| Usual Care | Double Support Time Coefficient of Variation | 0.23 Coefficient of variation | Standard Deviation 0.17 |
Secondary
Freezing of Gait Questionnaire
The Freezing of Gait Questionnaire assesses Freezing of Gait (FOG) severity unrelated to falls in patients with Parkinson's disease (PD), FOG frequency, disturbances in gait, and relationship to clinical features conceptually associated with gait and motor aspects. Six items are scored on 0-4 scale for a total score range of 0-24, with higher scores indicating worse outcomes.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Freezing of Gait Questionnaire | 9.00 score on a scale | Standard Deviation 6.49 |
| Usual Care | Freezing of Gait Questionnaire | 9.85 score on a scale | Standard Deviation 5.45 |
Secondary
Number of Participants With Falls
Number of participants who recorded falls in a log during the 8-week intervention
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Walking Training With the HWA Device | Number of Participants With Falls | 13 Participants |
| Usual Care | Number of Participants With Falls | 11 Participants |
Secondary
Participants' Perceived Ease of Walking
Indicated on a visual analog scale (line with demarcations of 0-10 spaced evenly and with anchors Not at all easy at 0 on the left end, moderately easy at 5, and Extremely easy at 10 on the right end). Participants are asked to rate where on line it indicates how easy it felt for them to walk during the six minute walk test.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Participants' Perceived Ease of Walking | 6.05 units on a scale | Standard Deviation 1.96 |
| Usual Care | Participants' Perceived Ease of Walking | 7.47 units on a scale | Standard Deviation 2.04 |
Secondary
Self-Efficacy for Measuring Chronic Disease 6-Item Scale
Questionnaire to measure participants' confidence (I.e., self-efficacy) in performing daily activities. The score for the scale is the mean of the 6 items with a range of possible scores from 1 to 10. Higher number (10) indicates higher self-efficacy.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Self-Efficacy for Measuring Chronic Disease 6-Item Scale | 7.71 score on a scale | Standard Deviation 1.5 |
| Usual Care | Self-Efficacy for Measuring Chronic Disease 6-Item Scale | 8.00 score on a scale | Standard Deviation 1.49 |
Secondary
Stride Length
Stride length in centimeters
Time frame: 8 weeks
Population: Missing data for one person in the training group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Stride Length | 128.96 Centimeters | Standard Deviation 25.53 |
| Usual Care | Stride Length | 131.79 Centimeters | Standard Deviation 30.87 |
Secondary
Stride Length Coefficient of Variation
The stride length coefficient of variation was calculated by first calculating the mean and SD of the stride length for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the stride length coefficient of variation required multiple measures for each participant. After calculating the stride length coefficients of variation for each participant, we then calculated the mean and SD of the stride length coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.
Time frame: 8 weeks
Population: Missing data for one person in the training group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Stride Length Coefficient of Variation | 0.07 Coefficient of variation | Standard Deviation 0.04 |
| Usual Care | Stride Length Coefficient of Variation | 0.08 Coefficient of variation | Standard Deviation 0.08 |
Secondary
Swing Time Coefficient of Variation of Left Leg
The swing time coefficient of variation of left leg was calculated by first calculating the mean and SD of the swing time of the left leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of left leg coefficient of variation required multiple measures for each participant. After calculating the swing time of left leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the left leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.
Time frame: 8 weeks
Population: Missing data for one person in the training group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Swing Time Coefficient of Variation of Left Leg | 0.05 Coefficient of variation | Standard Deviation 0.02 |
| Usual Care | Swing Time Coefficient of Variation of Left Leg | 0.06 Coefficient of variation | Standard Deviation 0.05 |
Secondary
Swing Time Coefficient of Variation of Right Leg
The swing time coefficient of variation of right leg was calculated by first calculating the mean and SD of the swing time of the right leg for each of the participants. The calculation of the coefficient of variations were done by taking the standard deviations and dividing them by the mean. Thus calculation of the swing time of right leg coefficient of variation required multiple measures for each participant. After calculating the swing time of right leg coefficients of variation for each participant, we then calculated the mean and SD of the swing time of the right leg coefficients of variation. This explains the data value with the measure of central tendency reported in the data table.
Time frame: 8 weeks
Population: Missing data for one person in the training group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Swing Time Coefficient of Variation of Right Leg | 0.05 Coefficient of variation | Standard Deviation 0.02 |
| Usual Care | Swing Time Coefficient of Variation of Right Leg | 0.05 Coefficient of variation | Standard Deviation 0.05 |
Secondary
Swing Time - Left Leg
Swing time in seconds of left leg
Time frame: 8 weeks
Population: Missing data for one person in the training group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Swing Time - Left Leg | 40.86 Seconds | Standard Deviation 3.06 |
| Usual Care | Swing Time - Left Leg | 41.47 Seconds | Standard Deviation 2.72 |
Secondary
Swing Time - Right Leg
Swing time in seconds of right leg
Time frame: 8 weeks
Population: Missing data for one person in the training group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Walking Training With the HWA Device | Swing Time - Right Leg | 41.28 Seconds | Standard Deviation 2.93 |
| Usual Care | Swing Time - Right Leg | 41.94 Seconds | Standard Deviation 2.37 |