MS (Multiple Sclerosis)Phase 1/2NCT00872053
Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
A Phase 1/2 study testing Anklebot and Lokomat in people with MS (Multiple Sclerosis), run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The primary aim of this study is to: 1. Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop; 2. Collect pilot data on the use of combination therapy on improving gait in subjects with MS. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- MS (Multiple Sclerosis)
- What is being tested?
- Anklebot and Lokomat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems.
- Presence of unilateral foot drop that is clinically apparent to the PI or PI designate.
- Must be able to ambulate 25 feet without an assisting device.
Who cannot join
- Cardiovascular: recent MI < 4 wk, uncontrolled HTN >190/110 mmHg.
- History of uncontrolled diabetes.
- Symptoms of orthostasis when standing up.
- Circulatory problems, history of vascular claudication or pitting edema.
- Unable to fully understand instructions in order to use the equipment or the process of the study.
- Body weight over 150 kg.
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- Lower extremity injuries that limit range of motion or function.
- Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment.
- Unstable fractures.
- Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus.
- Chronic and ongoing alcohol or drug abuse.
- Pre-morbid, ongoing depression or psychosis.
- Ongoing physical therapy.
- Pregnancy (self-reported)
- PI's determination of inability to complete the test protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center
Providence, Rhode Island, 02908-4799
About this study
The primary aim of this study is to:
- Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;
- Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training.
Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.
- Conditions
- MS (Multiple Sclerosis)
- Being tested
- Anklebot, Lokomat
- Keywords
- robot, treadmill, foot drop, rehabilitation, gait
- Medical subject headings
- Multiple Sclerosis, Peroneal Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnklebotDevice
The Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training "games," the Anklebot can assist ankle movement throughout 3 planes.
LokomatDevice
The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs over a treadmill through position controlled trajectories that mimic normal human gait patterns.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Focused Ankle Training Receives: Device: Anklebot |
| Arm 2 | Experimental | Combination Therapy Receives: Device: Anklebot; Device: Lokomat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle accuracy and stiffness
Measured: At inclusion, after 8 sessions, after 16 sessions
Secondary outcomes (2)
Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)
Measured: At inclusion, after every 4 sessions
Functional assessments (EDSS, MS Functional Composite)
Measured: At inclusion, after 8 sessions, after 16 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MS (Multiple Sclerosis)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Albert Lo, MD PhD, Principal investigator, Providence VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872053
- Sponsor's protocol ID
- B4125K-1
- Status last verified
- Sep 2013
- First submitted
- 27 Mar 2009
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00872053
- Acronym / sponsor ID
- B4125K-1
- Conditions
- MS (Multiple Sclerosis)
- Keywords
- robot, treadmill, foot drop, rehabilitation, gait
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 31 Mar 2009 (estimated)
- 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 primary aim of this study is to:
- Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop;
- Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training.
Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: AnklebotFocused Ankle Training |
| Arm 2 | Experimental | Device: Anklebot, Device: LokomatCombination Therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems.
- Presence of unilateral foot drop that is clinically apparent to the PI or PI designate.
- Must be able to ambulate 25 feet without an assisting device.
Key exclusion criteria (15 listed)
- Cardiovascular: recent MI < 4 wk, uncontrolled HTN >190/110 mmHg.
- History of uncontrolled diabetes.
- Symptoms of orthostasis when standing up.
- Circulatory problems, history of vascular claudication or pitting edema.
- Unable to fully understand instructions in order to use the equipment or the process of 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 |
|---|---|---|
| AnklebotThe Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training "games," the Anklebot can assist ankle movement throughout 3 planes. | Device | Arm 1, Arm 2 |
| LokomatThe Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs over a treadmill through position controlled trajectories that mimic normal human gait patterns. | Device | Arm 2 |
Primary outcome
Ankle accuracy and stiffness
Time frame: At inclusion, after 8 sessions, after 16 sessions
2 secondary outcomes
Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk)
Time frame: At inclusion, after every 4 sessions
Functional assessments (EDSS, MS Functional Composite)
Time frame: At inclusion, after 8 sessions, after 16 sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
Albert Lo, MD PhD principal investigator
Providence 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 Phase 1/2 study testing Anklebot and Lokomat in people with MS (Multiple Sclerosis), run by US Department of Veterans Affairs 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 15 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 Sep 2013. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ankle accuracy and stiffness (time frame: At inclusion, after 8 sessions, after 16 sessions). 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 Sep 2013.