HemiparesisPhase 1NCT00075283
Walking Therapy In Hemiparetic Stroke Patients Using Robotic-Assisted Treadmill Training
A Phase 1 study testing Lokomat (Robotic Orthosis) combined with slat belt treadmill in people with Hemiparesis and Stroke, run by U.S. Department of Education at 1 site in United States.
Trial summary
The overall goal of this study is to determine whether robotic-assisted gait training is better than standard physical therapy treatments for improving walking ability in hemiparetic stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiparesis, Stroke
- What is being tested?
- Lokomat (Robotic Orthosis) combined with slat belt treadmill
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to not given
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral brain lesion.
- Within 6 months post-stroke.
- Receiving no other therapy targeting function of lower limb.
- Demonstration of hemiparesis (motor dysfunction in lower limb).
- Able to walk 5 meters without therapist assistance (walking device only).
- Able to follow commands and protocol.
Who cannot join
- Significant cognitive or communication impairments.
- Uncontrolled hypertension.
- Uncontrolled diabetes.
- Clinical depression.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Rehabilitation Hospital
Washington D.C., District of Columbia, 20010
Cheryl M Lacsamana, BBE, 202-877-1889, cheryl.lacsamana@medstar.net
Dr. Joseph M Hidler, Ph.D.
About this study
Official title: Gait Restoration In Hemiparetic Stroke Patients Using Goal-Directed, Robotic-Assisted, Treadmill Training
The overall goal of this study is to determine whether robotic-assisted gait training is better than standard physical therapy treatments for improving walking ability in hemiparetic stroke patients.
Read the detailed description
Subjects enrolled into the study will be randomly assigned to one of 2 groups. The first group will receive one hour of conventional gait training, consisting of lower extremity strengthening exercises, stretching, and full weight bearing walking as tolerated, with appropriate physical assistance from a therapist. The second group will receive walking therapy using a Lokomat, which is a special treadmill that works in conjunction with 2 light-weight robotic arms that assists the subject to move their legs while they try to walk on the treadmill. Some of the subject's body-weight will be supported using a harness. During Lokomat training sessions, subjects will receive feedback of their walking performance on a computer monitor to help them walk. Both groups will be trained for 8-10 weeks, 3 times per week, for 1 hour training sessions (24 total sessions). Resources for transportation to the National Rehabilitation Hospital will be provided to all study participants.
- Conditions
- Hemiparesis, Stroke
- Being tested
- Lokomat (Robotic Orthosis) combined with slat belt treadmill
- Keywords
- Physical Therapy, Locomotion therapy, Gait training, Stroke, Robotics, Rehabilitation, Treadmill, Hemiparetic stroke, Unilateral brain lesion
- Medical subject headings
- Paresis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat (Robotic Orthosis) combined with slat belt treadmillDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2004 (estimated)
- Study startNov 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- U.S. Department of Education
- Sponsor type
- US federal agency
- Investigators
- Dr. Joseph M Hidler, Ph.D., Principal investigator, The Catholic University of America
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075283
- Sponsor's protocol ID
- H133E020724
- Other IDs
- IRB 2002-427
- Status last verified
- Jan 2004
- First submitted
- 8 Jan 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Restoration In Hemiparetic Stroke Patients Using Goal-Directed, Robotic-Assisted, Treadmill Training
- ClinicalTrials.gov ID
- NCT00075283
- Acronym / sponsor ID
- H133E020724
- Conditions
- Hemiparesis, Stroke
- Keywords
- Physical Therapy, Locomotion therapy, Gait training, Stroke, Robotics, Rehabilitation, Treadmill, Hemiparetic stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- U.S. Department of EducationUS federal agency
- Study start
- Nov 2002
- First posted
- 9 Jan 2004 (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 overall goal of this study is to determine whether robotic-assisted gait training is better than standard physical therapy treatments for improving walking ability in hemiparetic stroke patients.
Detailed description
Subjects enrolled into the study will be randomly assigned to one of 2 groups. The first group will receive one hour of conventional gait training, consisting of lower extremity strengthening exercises, stretching, and full weight bearing walking as tolerated, with appropriate physical assistance from a therapist. The second group will receive walking therapy using a Lokomat, which is a special treadmill that works in conjunction with 2 light-weight robotic arms that assists the subject to move their legs while they try to walk on the treadmill. Some of the subject's body-weight will be supported using a harness. During Lokomat training sessions, subjects will receive feedback of their walking performance on a computer monitor to help them walk. Both groups will be trained for 8-10 weeks, 3 times per week, for 1 hour training sessions (24 total sessions). Resources for transportation to the National Rehabilitation Hospital will be provided to all study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral brain lesion.
- Within 6 months post-stroke.
- Receiving no other therapy targeting function of lower limb.
- Demonstration of hemiparesis (motor dysfunction in lower limb).
- Able to walk 5 meters without therapist assistance (walking device only).
Key exclusion criteria (4 listed)
- Significant cognitive or communication impairments.
- Uncontrolled hypertension.
- Uncontrolled diabetes.
- Clinical depression.
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 |
|---|---|---|
| Lokomat (Robotic Orthosis) combined with slat belt treadmill | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Dr. Joseph M Hidler, Ph.D. principal investigator
The Catholic University of America
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lokomat (Robotic Orthosis) combined with slat belt treadmill in people with Hemiparesis and Stroke, run by U.S. Department of Education 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 6 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheryl M Lacsamana, BBE ((202)877-1889, cheryl.lacsamana@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 24 Jun 2005.