StrokeNCT02483676
Ankle Robot to Reduce Foot Drop in Stroke
A study testing Treadmill plus anklebot and Treadmill only in people with Stroke and Foot Drop, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented adaptive control system, this study tests whether robotic-assisted treadmill training will improve gait and balance functions in chronic stroke… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Treadmill plus anklebot and Treadmill only
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2015to 30 Jun 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic or hemorrhagic stroke > 2 months prior in men or women
- Residual hemiparesis of the lower extremity that includes symptoms of foot drop
- Capable of ambulating on a treadmill with handrail support
- Already completed all conventional physical therapy
- Adequate language and cognitive function to provide informed consent and participate in testing and training
Who cannot join
- Cardiac history of:
- Unstable angina
- Recent (< 3 months) myocardial infarction
- Congestive heart failure (NYHA category II or higher)
- Hemodynamic valvular dysfunction
- Hypertension that is a contraindication for a bout of treadmill training (>160/100 mmHg on two assessments)
Show all 18Show fewer
- Medical history of:
- Recent hospitalization (< 3 months) for any serious condition leading to significant bed-rest or reduction in mobility function
- Symptomatic peripheral arterial occlusive disease
- Orthopedic or chronic pain conditions restricting exercise
- Pulmonary failure requiring oxygen
- Uncompensated renal failure
- Active cancer
- Neurological history and exam consistent with:
- Dementia
- Receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2-point commands
- Non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome, myopathy)
- Untreated major depression
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
Official title: Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented adaptive control system, this study tests whether robotic-assisted treadmill training will improve gait and balance functions in chronic stroke survivors with foot drop impairment. It is hypothesized that, compared to treadmill training alone, integrating adaptive ankle robotics with treadmill training will reduce drop foot during independent overground walking, resulting in greater mobility, improved postural control, and reduced fall risk.
Read the detailed description
This proposal investigates a novel ankle robot (anklebot) adaptive control approach integrated with treadmill training to reduce foot drop and improve mobility function in chronic hemiparetic stroke survivors. Currently, stroke survivors with foot drop are trained to live with a cane or other assistive device, and often ankle foot orthotics (AFOs) for safety. Neither mediates task-practice or neuromotor recovery.
The investigators have developed an adaptive anklebot controller that detects gait cycle sub-events for precise timing of graded robotics assistance to enable deficit severity-adjusted ankle motor learning in the context of walking. The investigators' pilot findings show that 6 weeks treadmill training with anklebot (TMR) timed to assist swing phase dorsiflexion only is more effective than treadmill alone (TM) to improve free-walking swing dorsiflexion at foot strike, floor-walking speed, and the benefits are retained at 6 weeks post-training. Notably, swing-phase TMR training improved paretic leg push-off, and reduced center-of-pressure sway on standing balance, indicating potential benefits to other elements of gait and balance, beyond those robotically targeted toward foot drop.
This randomized study investigates the hypothesis that 6 weeks TMR is more effective to improve durably gait biomechanics, static, and dynamic balance, and mobility function in chronic stroke survivors with dorsiflexion deficits, compared to TM alone. Aims are to determine the compare effectiveness of 6 weeks TMR vs. TM alone on:
- Independent gait function indexed by gait velocity, swing-phase DF (dorsiflexion), terminal stance push-off.
- Balance function indexed by measures of postural sway (CoP), asymmetric loading in quiet standing, peak paretic A-P forces in non-paretic gait initiation, and standardized scales for balance and fall risk.
- Long-term mobility outcomes, assessed by repeated measures of all key gait and balance outcomes at 6 weeks and 3 months after formal training cessation.
- Being tested
- Treadmill plus anklebot, Treadmill only
- Keywords
- Rehabilitation, Robotics, Gait
- Medical subject headings
- Stroke, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill plus anklebotDevice
Also called TMR
This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
Treadmill onlyBehavioural
Also called TM
This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
| Study group | Role | What they receive |
|---|---|---|
| Treadmill+anklebot | Experimental | This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system. Receives: Device: Treadmill plus anklebot |
| Treadmill only | Active comparator | This group will receive gait training on a treadmill, without use of the anklebot. Receives: Behavioral: Treadmill only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Velocity During Self-selected Overground Walking
Gait velocity during self-selected overground walking measured in cm/sec
Measured: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Anterior-posterior Propulsion Forces of Paretic Side During Gait
Newtons: anterior-posterior force generated during push-off phase of the gait cycle
Measured: Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
Peak Dorsiflexion Angle During Swing Phase of Gait
Degrees; extent of ankle dorsiflexion to enable foot clearance
Measured: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Postural Sway Areas During Quiet Standing
cm^2; extent of postural deviations to assess static postural control
Measured: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Ratio of Asymmetric Loading in Quiet Standing
Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Measured: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Peak Paretic Push Off Forces During Gait Initiation
Newtons; magnitude of forward ground reaction forces
Measured: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start1 Sep 2015
- Primary completion1 Apr 2019
- Study completion30 Jun 2019
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.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven J Kittner, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483676
- Sponsor's protocol ID
- N1699-R
- Status last verified
- May 2020
- First submitted
- 19 Jun 2015
- Last updated
- 20 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
- ClinicalTrials.gov ID
- NCT02483676
- Acronym / sponsor ID
- N1699-R
- Keywords
- Rehabilitation, Robotics, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Posted 20 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented adaptive control system, this study tests whether robotic-assisted treadmill training will improve gait and balance functions in chronic stroke survivors with foot drop impairment. It is hypothesized that, compared to treadmill training alone, integrating adaptive ankle robotics with treadmill training will reduce drop foot during independent overground walking, resulting in greater mobility, improved postural control, and reduced fall risk.
Detailed description
This proposal investigates a novel ankle robot (anklebot) adaptive control approach integrated with treadmill training to reduce foot drop and improve mobility function in chronic hemiparetic stroke survivors. Currently, stroke survivors with foot drop are trained to live with a cane or other assistive device, and often ankle foot orthotics (AFOs) for safety. Neither mediates task-practice or neuromotor recovery.
The investigators have developed an adaptive anklebot controller that detects gait cycle sub-events for precise timing of graded robotics assistance to enable deficit severity-adjusted ankle motor learning in the context of walking. The investigators' pilot findings show that 6 weeks treadmill training with anklebot (TMR) timed to assist swing phase dorsiflexion only is more effective than treadmill alone (TM) to improve free-walking swing dorsiflexion at foot strike, floor-walking speed, and the benefits are retained at 6 weeks post-training. Notably, swing-phase TMR training improved paretic leg push-off, and reduced center-of-pressure sway on standing balance, indicating potential benefits to other elements of gait and balance, beyond those robotically targeted toward foot drop.
This randomized study investigates the hypothesis that 6 weeks TMR is more effective to improve durably gait biomechanics, static, and dynamic balance, and mobility function in chronic stroke survivors with dorsiflexion deficits, compared to TM alone. Aims are to determine the compare effectiveness of 6 weeks TMR vs. TM alone on:
- Independent gait function indexed by gait velocity, swing-phase DF (dorsiflexion), terminal stance push-off.
- Balance function indexed by measures of postural sway (CoP), asymmetric loading in quiet standing, peak paretic A-P forces in non-paretic gait initiation, and standardized scales for balance and fall risk.
- Long-term mobility outcomes, assessed by repeated measures of all key gait and balance outcomes at 6 weeks and 3 months after formal training cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill+anklebot | Experimental | Device: Treadmill plus anklebotThis group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system. |
| Treadmill only | Active comparator | Behavioral: Treadmill onlyThis group will receive gait training on a treadmill, without use of the anklebot. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ischemic or hemorrhagic stroke > 2 months prior in men or women
- Residual hemiparesis of the lower extremity that includes symptoms of foot drop
- Capable of ambulating on a treadmill with handrail support
- Already completed all conventional physical therapy
- Adequate language and cognitive function to provide informed consent and participate in testing and training
Key exclusion criteria (18 listed)
- Cardiac history of:
- Medical history of:
- Neurological history and exam consistent with:
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 |
|---|---|---|
| Treadmill plus anklebotAlso: TMRThis intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period. | Device | Treadmill+anklebot |
| Treadmill onlyAlso: TMThis intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period | Behavioural | Treadmill only |
Primary outcome
Gait Velocity During Self-selected Overground Walking
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Gait velocity during self-selected overground walking measured in cm/sec
Anterior-posterior Propulsion Forces of Paretic Side During Gait
Time frame: Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
Newtons: anterior-posterior force generated during push-off phase of the gait cycle
Peak Dorsiflexion Angle During Swing Phase of Gait
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
Degrees; extent of ankle dorsiflexion to enable foot clearance
Postural Sway Areas During Quiet Standing
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
cm^2; extent of postural deviations to assess static postural control
Ratio of Asymmetric Loading in Quiet Standing
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
Peak Paretic Push Off Forces During Gait Initiation
Time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
Newtons; magnitude of forward ground reaction forces
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Steven J Kittner principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill plus anklebot and Treadmill only in people with Stroke and Foot Drop, run by VA Office of Research and Development 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 5 inclusion and 18 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 20 May 2020. 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 20 May 2020). 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 During Self-selected Overground Walking (time frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2020.