Gait Re-training in Healthy SubjectsNCT01684267
Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields
A study testing Robotic Gait Rehabilitation (RGR) Trainer in people with Gait Re-training in Healthy Subjects and Gait Re-training in Stroke Survivors, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
To test the usability and effectiveness of a robotic device, called the Robotic Gait Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2) patients with stroke with gait abnormalities secondary to impaired knee function. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Re-training in Healthy Subjects, Gait Re-training in Stroke Survivors
- What is being tested?
- Robotic Gait Rehabilitation (RGR) Trainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2016
- Phase
- Interventional
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Can walk comfortably on a treadmill
- single non-traumatic ischemic or hemorrhagic stroke at least 6 months prior to enrollment
- persistent hemiparesis, mild spasticity, and residual mild-to-moderate weakness of the lower extremity
- residual deficits of gait
- be able to ambulate without the use of assistive devices or assistance of a person
- able to walk at a comfortable walking speed of ~0.6 m/s
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- able to walk safely on a treadmill
- medically stable
- No other neurological problems, or any known cardiovascular or musculoskeletal disorders that effects their gait or excludes them from exercise
Who cannot join
- any known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or gait disorder that results in an abnormal gait pattern
- Females in the second or third trimester of pregnancy
- STROKE
- unable to attend and follow instructions
- require physical assistance for ambulation
- other known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or gait disorder that results in an abnormal gait pattern
- severe joint contractures of the hemi-paretic knee
- females in the second or third trimester of pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
About this study
To test the usability and effectiveness of a robotic device, called the Robotic Gait Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2) patients with stroke with gait abnormalities secondary to impaired knee function.
Read the detailed description
The device is designed to train stroke patients to correct abnormal gait patterns associated with exaggerated and uncoordinated movements of the pelvis by applying force fields to correct the movement of the pelvis. The focus will be on correcting hip hiking (i.e. exaggerated unilateral upward movements of one side of the pelvis) in post-stroke patients. The human-robot interface will be based on impedance control techniques so that the force-field actuators generate smooth virtual spring/damper restitution forces at the patient's pelvic area.
As part of the study we will determine whether the force fields applied by the actuated components of the device can effect an acute change in gait biomechanics, primarily pelvis motion during stance and swing phases, in healthy subjects and patients with stroke during ambulation. The investigators will also evaluate the usability of the orthosis in terms of donning \& doffing, user confidence, and comfort.
- Being tested
- Robotic Gait Rehabilitation (RGR) Trainer
- Keywords
- Stroke, Gait, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Gait Rehabilitation (RGR) TrainerDevice
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Experimental | Healthy individuals Receives: Device: Robotic Gait Rehabilitation (RGR) Trainer |
| Post-stroke | Experimental | Chronic stroke survivors Receives: Device: Robotic Gait Rehabilitation (RGR) Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic obliquity
Change in pelvic obliquity during gait consequent to force application
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Re-training in Healthy SubjectsStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northeastern University
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684267
- Sponsor's protocol ID
- 2009-P-000447
- Status last verified
- Apr 2019
- First submitted
- 10 Sep 2012
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Obliquity Rehabilitation in Stroke Patients Using Robotically Generated Force Fields
- ClinicalTrials.gov ID
- NCT01684267
- Acronym / sponsor ID
- 2009-P-000447
- Keywords
- Stroke, Gait, Rehabilitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Northeastern University
- Study start
- Jan 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 12 Sep 2012 (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.
To test the usability and effectiveness of a robotic device, called the Robotic Gait Rehabilitation (RGR) Trainer, in (1) healthy subjects with no gait impairment and (2) patients with stroke with gait abnormalities secondary to impaired knee function.
Detailed description
The device is designed to train stroke patients to correct abnormal gait patterns associated with exaggerated and uncoordinated movements of the pelvis by applying force fields to correct the movement of the pelvis. The focus will be on correcting hip hiking (i.e. exaggerated unilateral upward movements of one side of the pelvis) in post-stroke patients. The human-robot interface will be based on impedance control techniques so that the force-field actuators generate smooth virtual spring/damper restitution forces at the patient's pelvic area.
As part of the study we will determine whether the force fields applied by the actuated components of the device can effect an acute change in gait biomechanics, primarily pelvis motion during stance and swing phases, in healthy subjects and patients with stroke during ambulation. The investigators will also evaluate the usability of the orthosis in terms of donning \& doffing, user confidence, and comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Experimental | Device: Robotic Gait Rehabilitation (RGR) TrainerHealthy individuals |
| Post-stroke | Experimental | Device: Robotic Gait Rehabilitation (RGR) TrainerChronic stroke survivors |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Can walk comfortably on a treadmill
- single non-traumatic ischemic or hemorrhagic stroke at least 6 months prior to enrollment
- persistent hemiparesis, mild spasticity, and residual mild-to-moderate weakness of the lower extremity
- residual deficits of gait
- be able to ambulate without the use of assistive devices or assistance of a person
Key exclusion criteria (8 listed)
- any known orthopedic, musculoskeletal, neurological, cardiovascular, pulmonary, or gait disorder that results in an abnormal gait pattern
- Females in the second or third trimester of pregnancy
- STROKE
- unable to attend and follow instructions
- require physical assistance for ambulation
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 |
|---|---|---|
| Robotic Gait Rehabilitation (RGR) Trainer | Device | Healthy, Post-stroke |
Primary outcome
Pelvic obliquity
Time frame: 1 day
Change in pelvic obliquity during gait consequent to force application
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Gait Rehabilitation (RGR) Trainer in people with Gait Re-training in Healthy Subjects and Gait Re-training in Stroke Survivors, run by Spaulding Rehabilitation Hospital 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 9 inclusion and 8 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 5 Apr 2019. 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?
The study was stopped early (reason given: Lack of funding). 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?
Pelvic obliquity (time frame: 1 day). 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 5 Apr 2019.