Parkinson DiseaseNCT03751371
Robotic Walking Device to Improve Mobility in Parkinson's Disease
A study testing Training with HWA device in people with Parkinson Disease, run by Ohio State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Training with HWA device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 27 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Robotic Walking Device to Improve Home and Community Mobility in People With Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Training with HWA device, Usual Care
- Keywords
- Parkinson, Exoskeleton, Honda, Walking Assist, Walking, Gait, Mobility, Rehabilitation, Physical Therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training with HWA deviceDevice
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.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Walking Training with the HWA Device | Experimental | Training with HWA device Receives: Device: Training with HWA device |
| Usual Care | Other | Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Velocity
Walking speed in meters per second
Measured: 8 weeks
Secondary outcomes (13)
6-Minute Walk Test
Distance walked in 6 minutes, reported in meters
Measured: 8 weeks
Stride Length
Stride length in centimeters
Measured: 8 weeks
Double Support Time
Double support time in seconds
Measured: 8 weeks
Swing Time - Right Leg
Swing time in seconds of right leg
Measured: 8 weeks
Swing Time - Left Leg
Swing time in seconds of left leg
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Number of Participants With Falls
Number of participants who recorded falls in a log during the 8-week intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start15 May 2019
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Honda Research and Development Americas
- Responsible party
- Principal investigator, Anne Kloos, Ohio State University
- Investigators
- Anne Kloos, Principal investigator, Ohio State UniversityDeb Kegelmeyer, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751371
- Sponsor's protocol ID
- 2018H0397
- Status last verified
- May 2023
- First submitted
- 11 Nov 2018
- Last updated
- 18 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Kegelmeyer DA, Minarsch R, Kostyk SK, Kline D, Smith R, Kloos AD. Use of a Robotic Walking Device for Home and Community Mobility in Parkinson Disease: A Randomized Controlled Trial. J Neurol Phys Ther. 2024 Apr 1;48(2):102-111. doi: 10.1097/NPT.0000000000000467. Epub 2024 Mar 4.
PubMed 38441461Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Robotic Walking Device to Improve Home and Community Mobility in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03751371
- Acronym / sponsor ID
- 2018H0397
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Exoskeleton, Honda, Walking Assist, Walking, Gait, Mobility, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Honda Research and Development Americas
- Study start
- 15 May 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Posted 18 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking Training with the HWA Device | Experimental | Device: Training with HWA deviceTraining with HWA device |
| Usual Care | Other | Other: Usual CareUsual Care |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training with HWA deviceGait 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. | Device | Walking Training with the HWA Device |
| Usual CareThe 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. | Other | Usual Care |
Primary outcome
Gait Velocity
Time frame: 8 weeks
Walking speed in meters per second
13 secondary outcomes
6-Minute Walk Test
Time frame: 8 weeks
Stride Length
Time frame: 8 weeks
Double Support Time
Time frame: 8 weeks
Swing Time - Right Leg
Time frame: 8 weeks
Swing Time - Left Leg
Time frame: 8 weeks
Double Support Time Coefficient of Variation
Time frame: 8 weeks
Swing Time Coefficient of Variation of Right Leg
Time frame: 8 weeks
Swing Time Coefficient of Variation of Left Leg
Time frame: 8 weeks
Stride Length Coefficient of Variation
Time frame: 8 weeks
Participants' Perceived Ease of Walking
Time frame: 8 weeks
Self-Efficacy for Measuring Chronic Disease 6-Item Scale
Time frame: 8 weeks
Freezing of Gait Questionnaire
Time frame: 8 weeks
Number of Participants With Falls
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 38441461Kegelmeyer DA, Minarsch R, Kostyk SK, Kline D, Smith R, Kloos AD. Use of a Robotic Walking Device for Home and Community Mobility in Parkinson Disease: A Randomized Controlled Trial. J Neurol Phys Ther. 2024 Apr 1;48(2):102-111. doi: 10.1097/NPT.0000000000000467. Epub 2024 Mar 4.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Kloos principal investigator
Ohio State University
Deb Kegelmeyer principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training with HWA device in people with Parkinson Disease, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Velocity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751371, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.