Peripheral Nervous System DiseasesNCT03530592
Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
A study testing Seated Ankle Robot Training in people with Peripheral Nervous System Diseases and Gait Disorders, Neurologic, run by Baltimore VA Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Peripheral Nervous System Diseases, Gait Disorders, Neurologic, Foot Drop
- What is being tested?
- Seated Ankle Robot Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, aged 18 to 88 years
- Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
- Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device[s] is permitted)
Who cannot join
- Medical history that would preclude participation in low-intensity seated robotic-assisted rehabilitation
- Current participation in orthopedic or rehabilitation medical programs
- Active deep venous thrombosis
- Distal paretic leg skin lesions, infections, or soft tissue inflammation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
Kate C. Flores
Charlene E. Hafer-Macko, M.D.
About this study
The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.
Read the detailed description
Many individuals with central nervous system (CNS) injuries (e.g., a stroke) or peripheral nervous system (PNS) injuries (e.g., peroneal nerve injury, neuropathy, radiculopathy, and/or musculoskeletal injury) that affect their ankle movement have residual impairments that affect their walking and balance. These impairments include the disability "foot drop," which increases the risk for falling.
This study will focus on PNS injuries that cause foot drop.
Current therapy to address foot drop is limited primarily to the use of ankle foot orthoses (braces) that help keep the foot from hitting the ground to prevent falling. Also, some individuals with foot drop use functional electrical stimulation to the leg nerve to lift the foot. Regardless, none of these, or other existing, methods to address foot drop cures or even improves significantly the underlying neurological deficit behind this disability. Braces improve walking safety only while they are worn, and functional electrical stimulation does not work when it is turned off, or when the nerve has been severely damaged. Thus, the increased fall risk due to foot drop is generally considered life-long and incurable.
The investigators have developed a shoe-interfaced ankle robot with an adaptive control system, to assist an individual with ankle movement only as needed. Data from the investigators' previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals with foot drop. The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop.
- Conditions
- Peripheral Nervous System Diseases, Gait Disorders, Neurologic, Foot Drop, Mobility Limitation
- Being tested
- Seated Ankle Robot Training
- Medical subject headings
- Peripheral Nervous System Diseases, Gait Disorders, Neurologic, Peroneal Neuropathies, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated Ankle Robot TrainingDevice
This intervention employs the use of an adaptive ankle robot control system over a 6-week intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Seated Ankle Robot Training | Experimental | Not described Receives: Device: Seated Ankle Robot Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle dorsiflexion-plantarflexion range of motion
degrees
Measured: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Ankle inversion-eversion range of motion
degrees
Measured: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Gait velocity during self-selected overground walking
cm/sec
Measured: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Postural sway areas during quiet standing
cm^2; extent of postural deviations to assess static postural control
Measured: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Ratio of asymmetric loading in quiet standing
ratio of Newtons of force per leg while standing quietly
Measured: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Push-off forces during gait initiation
Newtons; magnitude of forward ground reaction forces.
Measured: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nervous System DiseasesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Seated Ankle Robot Taining
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Charlene Elaine Hafer-Macko, Baltimore VA Medical Center
- Investigators
- Charlene E. Hafer-Macko, M.D., Principal investigator, Baltimore VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530592
- Sponsor's protocol ID
- HP-68734
- Status last verified
- May 2018
- First submitted
- 10 Apr 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seated Ankle Robot for Foot Drop in Aging and Disabled Populations: A Demonstration Project
- ClinicalTrials.gov ID
- NCT03530592
- Acronym / sponsor ID
- HP-68734
- Conditions
- Peripheral Nervous System Diseases, Gait Disorders, Neurologic, Foot Drop, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test the utility of an ankle robot in people with ankle weakness and foot drop from a peripheral nervous system injury due to neuromuscular or orthopedic injury.
Detailed description
Many individuals with central nervous system (CNS) injuries (e.g., a stroke) or peripheral nervous system (PNS) injuries (e.g., peroneal nerve injury, neuropathy, radiculopathy, and/or musculoskeletal injury) that affect their ankle movement have residual impairments that affect their walking and balance. These impairments include the disability "foot drop," which increases the risk for falling.
This study will focus on PNS injuries that cause foot drop.
Current therapy to address foot drop is limited primarily to the use of ankle foot orthoses (braces) that help keep the foot from hitting the ground to prevent falling. Also, some individuals with foot drop use functional electrical stimulation to the leg nerve to lift the foot. Regardless, none of these, or other existing, methods to address foot drop cures or even improves significantly the underlying neurological deficit behind this disability. Braces improve walking safety only while they are worn, and functional electrical stimulation does not work when it is turned off, or when the nerve has been severely damaged. Thus, the increased fall risk due to foot drop is generally considered life-long and incurable.
The investigators have developed a shoe-interfaced ankle robot with an adaptive control system, to assist an individual with ankle movement only as needed. Data from the investigators' previous studies on foot drop due to stroke show great promise for this ankle robot as a new rehabilitation tool for invididuals with foot drop. The investigators would like to utilize our findings from these stroke studies in learning how they can be used for PNS-related foot drop.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Seated Ankle Robot Taining
| Arm | Type | Receives |
|---|---|---|
| Seated Ankle Robot Training | Experimental | Device: Seated Ankle Robot Training |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women, aged 18 to 88 years
- Chronic foot drop and ankle weakness in one leg from a peripheral nervous system injury due to a neuromuscular or orthopedic injury
- Ability to walk 10 meters and arise from a chair with no human assistance (but usage of usual assistive device[s] is permitted)
Key exclusion criteria (4 listed)
- Medical history that would preclude participation in low-intensity seated robotic-assisted rehabilitation
- Current participation in orthopedic or rehabilitation medical programs
- Active deep venous thrombosis
- Distal paretic leg skin lesions, infections, or soft tissue inflammation
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 |
|---|---|---|
| Seated Ankle Robot TrainingThis intervention employs the use of an adaptive ankle robot control system over a 6-week intervention period. | Device | Seated Ankle Robot Training |
Primary outcome
Ankle dorsiflexion-plantarflexion range of motion
Time frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
degrees
Ankle inversion-eversion range of motion
Time frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
degrees
Gait velocity during self-selected overground walking
Time frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
cm/sec
Postural sway areas during quiet standing
Time frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
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 weeks of training, and 6 weeks after completion of training
ratio of Newtons of force per leg while standing quietly
Push-off forces during gait initiation
Time frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training
Newtons; magnitude of forward ground reaction forces.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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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.
Charlene E. Hafer-Macko, M.D. principal investigator
Baltimore VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seated Ankle Robot Training in people with Peripheral Nervous System Diseases and Gait Disorders, Neurologic, run by Baltimore VA Medical Center 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 May 2018. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate C. Flores ((410) 637-3242, kate.flores@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle dorsiflexion-plantarflexion range of motion (time frame: Change from baseline to: post-6 weeks of training, and 6 weeks after completion of training). 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 21 May 2018.