Multiple SclerosisPhase 1/2NCT00766272
Lokomat Training Effects on MS Gait Abnormalities
A Phase 1/2 study testing Lokomat in people with Multiple Sclerosis, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Multiple sclerosis is a degenerative disease that affects more than 400,000 people in the US alone. MS is in fact the most common disabling neurological disorder in young adults. Symptoms of the disease can include problems with balance, walking, fatigue, weakness and vision. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Lokomat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2008
- 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
- Diagnosis of MS by McDonald criteria
- Ability to clearly understand written and oral direction in English
- Self-reported gait problem
- One or more falls in the past 6 months
- The ability to walk 25 feet with no more than a cane for assistance (The subject must be comfortable using a cane)
- Age 18-70
- Written informed consent to participate in the study
- Approval from subject's primary care physician for physical activity
Who cannot join
- No relapse within the last 3 months
- No more than two relapses within the past 12 months
- Recent myocardial infarction
- Uncontrolled hypertension or diabetes
- Symptomatic fall in blood pressure when standing
- Vascular claudication or pitting edema
Show all 20Show fewer
- Cognitive impairments that limit comprehension of protocol instructions (assessed by Comprehension Test of Consent Form)
- Body weight over 150 kg
- FES-I < 25
- 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
- Unstable fractures
- Pressure sores with any skin breakdown in areas in contact with the body harness or the robot-driven gait orthotic apparatus
- Currently enrolled in an alcohol or drug treatment program
- A complicating medical condition that would prevent completion of the trial
- Enrolled in or planning to enroll in another interventional research trial using procedures proposed to enhance or limit the function of the upper or lower extremities (such as adjuvant rehabilitation or Botox injections) during the 24 weeks of participation
- A difference of more than 2cm between subjects' right and left leg lengths
- Unable to be properly fit into the harness or Lokomat device
- Hypertonicity or spasticity that it interferes with a proper fit into the Lokomat
- Pregnancy at enrollment, as determined by a home pregnancy test kit at screening visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence VA Medical Center
Providence, Rhode Island, 02908-4799
About this study
Official title: Gait Rehabilitation for Multiple Sclerosis Using Robot-assisted Body-weight-supported Treadmill Training (Lokomat)
Multiple sclerosis is a degenerative disease that affects more than 400,000 people in the US alone. MS is in fact the most common disabling neurological disorder in young adults. Symptoms of the disease can include problems with balance, walking, fatigue, weakness and vision. Over 85% of people with Multiple Sclerosis have problems walking. This can cause them to fall or have a constant fear of falling. To prevent falling, MS patients rely on equipment, such as walkers and canes. These costs can cause financial difficulties for MS patients and families.
A significant problem that is only recently being studied is the relationship between falling and MS. Recent studies have shown that MS patients fall more often than those without MS, and also fall more than the elderly population. The consequent fear of falling is also an important problem, as those worried about falling will probably change their daily habits to lower their risk. This can mean keeping from certain physical and social activities or even staying indoors. Thus, falls and fear of falling can have negative medical, physical, psychological, and social consequences for the patient.
Read more
Improving patients' walking may help reduce falls and the fear of falling. Treadmill training has been shown to improve walking in patients with MS and to lower their risk of falling. One way to train patients on a treadmill is with the use of robots that can help move their limbs in a more normal way. This kind of robot-assisted treadmill training may provide even greater benefits than treadmill training alone.
The study is expected to last 6-7.5 months. One group of participants will receive weekly telephone calls and will be asked questions on other physical activities, falls, and activity limitations the patient had during the week. Participants assigned to robot-assisted treadmill training will receive twice weekly training session for 8 weeks, for a total of 16 sessions. Each session will last about 65 to 90 minutes.
The goal of this study is to see if robot-assisted treadmill training will reduce falls and fear of falling in patients with MS. Robot-assisted treadmill training has been shown to be effective in reducing falls and fear of falling in Parkinson's disease patients. This type of training has not been tested in patients with Multiple Sclerosis. The proposed study will help to address this gap and also provide additional data on other possible improvements due to robot-assisted treadmill training including ambulation, social participation, fatigue, and balance.
- Conditions
- Multiple Sclerosis
- Being tested
- Lokomat
- Keywords
- Rehabilitation, Treadmill, MS, Gait, Robot
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LokomatDevice
Body-weight will be supported using a harness, which suspends the subject above a motorized treadmill (Lokomat, Hocoma, Zurich, Switzerland). The system also incorporates a robot-driven gait orthotic, called the Lokomat, which will be secured to the subject's lower extremity and pelvis using adjustable cuffs and pads. The Lokomat uses computer-controlled motors to drive the hips and knees toward more normative kinematic patterns for gait.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Body-weight supported treadmill training Receives: Device: Lokomat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Falls
Measured: 6-7.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Study re-designed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- 20 participants (actual)
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
- NCT00766272
- Sponsor's protocol ID
- LO-0003
- Status last verified
- Sep 2013
- First submitted
- 2 Oct 2008
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Rehabilitation for Multiple Sclerosis Using Robot-assisted Body-weight-supported Treadmill Training (Lokomat)
- ClinicalTrials.gov ID
- NCT00766272
- Acronym / sponsor ID
- LO-0003
- Conditions
- Multiple Sclerosis
- Keywords
- Rehabilitation, Treadmill, MS, Gait, Robot
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study re-designed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Oct 2008 (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.
Multiple sclerosis is a degenerative disease that affects more than 400,000 people in the US alone. MS is in fact the most common disabling neurological disorder in young adults. Symptoms of the disease can include problems with balance, walking, fatigue, weakness and vision. Over 85% of people with Multiple Sclerosis have problems walking. This can cause them to fall or have a constant fear of falling. To prevent falling, MS patients rely on equipment, such as walkers and canes. These costs can cause financial difficulties for MS patients and families.
A significant problem that is only recently being studied is the relationship between falling and MS. Recent studies have shown that MS patients fall more often than those without MS, and also fall more than the elderly population. The consequent fear of falling is also an important problem, as those worried about falling will probably change their daily habits to lower their risk. This can mean keeping from certain physical and social activities or even staying indoors. Thus, falls and fear of falling can have negative medical, physical, psychological, and social consequences for the patient.
Improving patients' walking may help reduce falls and the fear of falling. Treadmill training has been shown to improve walking in patients with MS and to lower their risk of falling. One way to train patients on a treadmill is with the use of robots that can help move their limbs in a more normal way. This kind of robot-assisted treadmill training may provide even greater benefits than treadmill training alone.
The study is expected to last 6-7.5 months. One group of participants will receive weekly telephone calls and will be asked questions on other physical activities, falls, and activity limitations the patient had during the week. Participants assigned to robot-assisted treadmill training will receive twice weekly training session for 8 weeks, for a total of 16 sessions. Each session will last about 65 to 90 minutes.
The goal of this study is to see if robot-assisted treadmill training will reduce falls and fear of falling in patients with MS. Robot-assisted treadmill training has been shown to be effective in reducing falls and fear of falling in Parkinson's disease patients. This type of training has not been tested in patients with Multiple Sclerosis. The proposed study will help to address this gap and also provide additional data on other possible improvements due to robot-assisted treadmill training including ambulation, social participation, fatigue, and balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Device: LokomatBody-weight supported treadmill training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of MS by McDonald criteria
- Ability to clearly understand written and oral direction in English
- Self-reported gait problem
- One or more falls in the past 6 months
- The ability to walk 25 feet with no more than a cane for assistance (The subject must be comfortable using a cane)
Key exclusion criteria (20 listed)
- No relapse within the last 3 months
- No more than two relapses within the past 12 months
- Recent myocardial infarction
- Uncontrolled hypertension or diabetes
- Symptomatic fall in blood pressure when standing
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 |
|---|---|---|
| LokomatBody-weight will be supported using a harness, which suspends the subject above a motorized treadmill (Lokomat, Hocoma, Zurich, Switzerland). The system also incorporates a robot-driven gait orthotic, called the Lokomat, which will be secured to the subject's lower extremity and pelvis using adjustable cuffs and pads. The Lokomat uses computer-controlled motors to drive the hips and knees toward more normative kinematic patterns for gait. | Device | Arm 1 |
Primary outcome
Frequency of Falls
Time frame: 6-7.5 months
Results and safety
The study was stopped early (reason given: Study re-designed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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 Lokomat in people with 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 8 inclusion and 20 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: stopped early, as of the sponsor's last update on 23 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 was stopped early (reason given: Study re-designed). Results are not available in the source record.
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?
Frequency of Falls (time frame: 6-7.5 months). 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 23 Sep 2013.