StrokeNCT03171207
Evaluation of a Novel Gait Training Device to Support Body Weight
A study testing Lite Run Gait Trainer and Current Harness System in people with Stroke and Brain Injuries, Traumatic, run by Lite Run Inc..
Trial summary
A novel body weight support device that uses pressurized pants may provide advantages in delivering gait therapy. The objectives of this study are to test the following hypotheses that 1) the novel device will allow for increased body weight support while improving or maintaining the same level of patient comfort; 2)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke, Brain Injuries, Traumatic, Spinal Cord Injuries
- What is being tested?
- Lite Run Gait Trainer and Current Harness System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Sep 2017
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans age: 18-90 years, male or female,
- Who are receiving physical therapy as an inpatient at MVAHCS,
- Have Functional Independence Measure (FIM) scores of 0 or 1 (out of 7) in at least one of the five domains of motor tasks: 1) bed, chair, and wheelchair transfers, 2) toilet transfers, 3) tub/shower transfers, 4) walk/wheelchair locomotion, 5) stair locomotion,
- Who are determined by VA standards to require at least 35 pounds of physical support, such that 2 or more physical therapists and/or aides are needed during therapy, and
- Are able to understand informed consent.
Who cannot join
- Patients who have active clostridium difficile,
- An acute diagnosis of deep vein thrombosis, chronic deep vein thrombosis, or phlebitis (unless cleared by clinician to participate in the study),
- A lower body pressure ulcer worse than grade one (EPUAP), or an open wound,
- A history of any drug-resistant pathogen, such as Methicillin-resistant Staphylococcus aureus (MRSA) or Vancomycin-resistant enterococci (VRE), ESBL producing gram-negative bacilli, or others,
- Weigh more than 350 lbs.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of a Novel Gait Training Device Using a Pressurized Lower Body Suit to Support Body Weight
A novel body weight support device that uses pressurized pants may provide advantages in delivering gait therapy. The objectives of this study are to test the following hypotheses that 1) the novel device will allow for increased body weight support while improving or maintaining the same level of patient comfort; 2) the novel device will yield greater patient satisfaction with gait therapy relative to current harness systems; 3) therapists will be more satisfied with the use of the novel device relative to current harness systems; 4) the use of the novel device will require less total therapist time than a harness comparator; 5) the use of the novel device will increase therapeutic treatment time when compared with current harness systems.
Read the detailed description
This is a single group repeated measures ABAB design. The study will include four sessions for each participant, with two sessions conducted using a novel Lite Run Gait Trainer device (Lite Run, Inc., Minneapolis, MN) and two sessions conducted using the comparator method of choice by the physical therapist (harness system). The initial condition (harness or Lite Run) will be randomized. The overall gait training physical therapy session will follow standard of care; the only factor that will change will be the assistive device used during therapy (harness or Lite Run).
Participants will include 10 VA inpatients receiving physical therapy at the Minneapolis VA Health Care System (MVAHCS). Patients will be recruited from three VA rehabilitation units: Physical Medicine and Rehabilitation (PM\&R), Spinal Cord Injury and Disease (SCI/D) Center, and Community Living Center (CLC). Participants will have a range of diagnoses: stroke, traumatic brain injury, spinal cord injury, wounds, obesity.
The number of therapists and their time involvement will be tracked as a primary outcome measure in this study. The effectiveness of treatment will also be assessed for both assistive device methods. The total amount of therapeutic treatment time will be measured as the time spent by the patient in an upright position. At the end of each therapy session, participants will also be asked to rate their pain (comfort), perceived level of exertion, and will fill out a questionnaire about their experience with the Lite Run Gait Trainer. The physical therapists involved in the study will also provide their feedback.
- Being tested
- Lite Run Gait Trainer, Current Harness System
- Keywords
- Gait Therapy
- Medical subject headings
- Stroke, Brain Injuries, Traumatic, Spinal Cord Injuries, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lite Run Gait TrainerDevice
The Lite Run Gait Trainer is a novel device with pneumatic pants that can be used to assist with body support assisted gait therapy.
Current Harness SystemDevice
There are a variety of harness systems (e.g., ceiling lift, Lite Gait) that are currently used to assist with body support assisted gait therapy.
| Study group | Role | What they receive |
|---|---|---|
| Start with Lite Run Gait Trainer | Experimental | Patients start therapy with the Lite Run Gait Trainer device, followed by a Current Harness System in an ABAB design. Receives: Device: Lite Run Gait Trainer; Device: Current Harness System |
| Start with Current Harness System | Experimental | Patients start therapy with a Current Harness System, followed by the Lite Run Gait Trainer in an ABAB design. Receives: Device: Lite Run Gait Trainer; Device: Current Harness System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of therapists and/or aides required for a therapy session
Count of therapists and/or aides involved in therapy
Measured: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Total therapist and/or aide time involved in a session
Total cumulative time (min) for all therapists and aides involved in a therapy session
Measured: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Secondary outcomes (5)
Total time spent by patient in an upright position during a therapy session
Total time spent (min) by patient in an upright position
Measured: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Amount of unweighting
The amount of unweighting (pounds of body support) will be measured using a scale
Measured: Will be assessed during the first five minutes of each therapy session following fitting of harnessing system
Numerical pain rating scale
Patient rating of pain (on a 0-10 numerical scale) will be assessed at the end of each therapy session
Measured: Will be assessed at the end of each therapy session (approximately 60 minutes)
Patient Satisfaction
The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given
Measured: Will be assessed after the last session in each study arm (i.e., after two therapy sessions lasting approximately 60 minutes each)
Therapist Satisfaction
The first 8 questions of the Modified Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) will be given
Measured: Will be assessed at the end of the study (i.e., after four therapy sessions lasting approximately 60 minutes each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study startJun 2017 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lite Run Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Minneapolis Veterans Affairs Medical Center, TREAT
- Responsible party
- Sponsor
- Investigators
- Sara R Koehler-McNicholas, PhD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171207
- Sponsor's protocol ID
- 4698-A
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Gait Training Device Using a Pressurized Lower Body Suit to Support Body Weight
- ClinicalTrials.gov ID
- NCT03171207
- Acronym / sponsor ID
- 4698-A
- Keywords
- Gait Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lite Run Inc.Industry (pharma, biotech, devices)
- Collaborators
- Minneapolis Veterans Affairs Medical Center, TREAT
- Study start
- Jun 2017 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 31 May 2017 (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.
A novel body weight support device that uses pressurized pants may provide advantages in delivering gait therapy. The objectives of this study are to test the following hypotheses that 1) the novel device will allow for increased body weight support while improving or maintaining the same level of patient comfort; 2) the novel device will yield greater patient satisfaction with gait therapy relative to current harness systems; 3) therapists will be more satisfied with the use of the novel device relative to current harness systems; 4) the use of the novel device will require less total therapist time than a harness comparator; 5) the use of the novel device will increase therapeutic treatment time when compared with current harness systems.
Detailed description
This is a single group repeated measures ABAB design. The study will include four sessions for each participant, with two sessions conducted using a novel Lite Run Gait Trainer device (Lite Run, Inc., Minneapolis, MN) and two sessions conducted using the comparator method of choice by the physical therapist (harness system). The initial condition (harness or Lite Run) will be randomized. The overall gait training physical therapy session will follow standard of care; the only factor that will change will be the assistive device used during therapy (harness or Lite Run).
Participants will include 10 VA inpatients receiving physical therapy at the Minneapolis VA Health Care System (MVAHCS). Patients will be recruited from three VA rehabilitation units: Physical Medicine and Rehabilitation (PM\&R), Spinal Cord Injury and Disease (SCI/D) Center, and Community Living Center (CLC). Participants will have a range of diagnoses: stroke, traumatic brain injury, spinal cord injury, wounds, obesity.
The number of therapists and their time involvement will be tracked as a primary outcome measure in this study. The effectiveness of treatment will also be assessed for both assistive device methods. The total amount of therapeutic treatment time will be measured as the time spent by the patient in an upright position. At the end of each therapy session, participants will also be asked to rate their pain (comfort), perceived level of exertion, and will fill out a questionnaire about their experience with the Lite Run Gait Trainer. The physical therapists involved in the study will also provide their feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Start with Lite Run Gait Trainer | Experimental | Device: Lite Run Gait Trainer, Device: Current Harness SystemPatients start therapy with the Lite Run Gait Trainer device, followed by a Current Harness System in an ABAB design. |
| Start with Current Harness System | Experimental | Device: Lite Run Gait Trainer, Device: Current Harness SystemPatients start therapy with a Current Harness System, followed by the Lite Run Gait Trainer in an ABAB design. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veterans age: 18-90 years, male or female,
- Who are receiving physical therapy as an inpatient at MVAHCS,
- Have Functional Independence Measure (FIM) scores of 0 or 1 (out of 7) in at least one of the five domains of motor tasks: 1) bed, chair, and wheelchair transfers, 2) toilet transfers, 3) tub/shower transfers, 4) walk/wheelchair locomotion, 5) stair locomotion,
- Who are determined by VA standards to require at least 35 pounds of physical support, such that 2 or more physical therapists and/or aides are needed during therapy, and
- Are able to understand informed consent.
Key exclusion criteria (5 listed)
- Patients who have active clostridium difficile,
- An acute diagnosis of deep vein thrombosis, chronic deep vein thrombosis, or phlebitis (unless cleared by clinician to participate in the study),
- A lower body pressure ulcer worse than grade one (EPUAP), or an open wound,
- A history of any drug-resistant pathogen, such as Methicillin-resistant Staphylococcus aureus (MRSA) or Vancomycin-resistant enterococci (VRE), ESBL producing gram-negative bacilli, or others,
- Weigh more than 350 lbs.
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 |
|---|---|---|
| Lite Run Gait TrainerThe Lite Run Gait Trainer is a novel device with pneumatic pants that can be used to assist with body support assisted gait therapy. | Device | Start with Current Harness System, Start with Lite Run Gait Trainer |
| Current Harness SystemThere are a variety of harness systems (e.g., ceiling lift, Lite Gait) that are currently used to assist with body support assisted gait therapy. | Device | Start with Current Harness System, Start with Lite Run Gait Trainer |
Primary outcome
Number of therapists and/or aides required for a therapy session
Time frame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Count of therapists and/or aides involved in therapy
Total therapist and/or aide time involved in a session
Time frame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Total cumulative time (min) for all therapists and aides involved in a therapy session
5 secondary outcomes
Total time spent by patient in an upright position during a therapy session
Time frame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)
Amount of unweighting
Time frame: Will be assessed during the first five minutes of each therapy session following fitting of harnessing system
Numerical pain rating scale
Time frame: Will be assessed at the end of each therapy session (approximately 60 minutes)
Patient Satisfaction
Time frame: Will be assessed after the last session in each study arm (i.e., after two therapy sessions lasting approximately 60 minutes each)
Therapist Satisfaction
Time frame: Will be assessed at the end of the study (i.e., after four therapy sessions lasting approximately 60 minutes each)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No
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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.
Sara R Koehler-McNicholas, PhD principal investigator
Minneapolis Veterans Affairs Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Lite Run Gait Trainer and Current Harness System in people with Stroke and Brain Injuries, Traumatic, run by Lite Run Inc..
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 5 inclusion and 5 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Hauck, MSEE (651 336 7405, john@literun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of therapists and/or aides required for a therapy session (time frame: From beginning of each therapy session to the end of each therapy session (approximately 60 minutes)). The study lists 2 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 31 May 2017.