Spinal Cord InjuriesNCT00883142
Functional and Physiological Responses to Lokomat Therapy (Pilot Study)
An observational study of Spinal Cord Injuries and Multiple Sclerosis, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Individuals with neurological deficiencies such as those who have spinal cord injury, stroke, traumatic brain injury, Parkinson's disease, and multiple sclerosis often lose their ability to ambulate over ground. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Multiple Sclerosis, Stroke
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Mar 2013
- Phase
- Observational
- 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
Study population: Lokomat Rehabilitation Clinic
Who may be able to join
- The inclusion criteria are based on the guidelines set by the clinical Lokomat therapy program.
- Patients will have been evaluated on the Rehabilitation Service for entry into the clinical therapy program.
- Any patient who is already eligible for Lokomat therapy is a candidate for this research project.
Who cannot join
- Pregnant women
- History of fractures of the lower extremities
- Bone density study indicating bone loss greater than 5 standard deviations from normal.
- Fixed contractures of the ankles, knees or hips
- Uncontrolled spasticity that significantly interferes with movement of lower extremities.
- Uncooperative, unmotivated patients or patients whom cannot follow instructions on a consistent basis or communicate effectively with the treating clinicians.
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- Pressure ulcers over the greater trochanters, ischial tuberosities and sacrum.
- Weight greater than 250 lbs
- severe orthostatic hypotension (drop in blood pressure more than 30mm Hg when moving from sitting to standing posture)
- Acute medical illness (i.e. infection)
- Recently documented DVT in lower extremities
- SCI ASIA's A and B
Trial locations and contacts
1 site in 1 country.
About this study
Individuals with neurological deficiencies such as those who have spinal cord injury, stroke, traumatic brain injury, Parkinson's disease, and multiple sclerosis often lose their ability to ambulate over ground. Loss of functional mobility not only impedes everyday life, but may also affect many systems and organs in the body. The investigators are interested in obtaining a wide variety of data in order to obtain a better understanding of changes that occur as a result of receiving Lokomat therapy. The investigators will be studying body composition, cardiac, pulmonary, endocrine, metabolic, and molecular changes after a 12-week clinical therapy program.
Read the detailed description
Description of the Clinical Lokomat Therapy program:
This is a 12-week program with 3 to 5 sessions per week. Each session includes: 15-20 minutes of patient set-up (set-up time becomes about 5 to 10 minutes after a few sessions), 5-10 minutes of warm-up, 20-40 minutes of Lokomat therapy, 5-10 minutes of cool-down, and 5-10 minutes to remove the patient from the system. During the Lokomat sessions, heart rate and blood pressure are monitored by the therapist and recorded. Work performed is measured and recorded in the Lokomat computer for time, speed, amount of weight bearing, and distance.
Description of the Research Component:
A pre and post, prospective study design will be employed. Baseline measurements (Please see below and Table 1 for detailed descriptions) will be performed prior to start of the Lokomat therapy program and then again after completion of the 12-week program. A chart review will be performed at baseline only for documentation of medical history and medications. In a subset of patients a muscle biopsy will be performed for gene expression at baseline and week 12.
As part of Clinical Care, during each of the Lokomat therapy sessions the following information is collected:
- Work (total time, speed, distance, amount of weight bearing)
- Heart rate (HR)
- Blood Pressure (SBP, DBP)
- Perception of exertion (Borg Scale)
- Lipid profile (pre and post)
- Albumin (pre and post)
For Research purposes the following is being proposed:
Review and record work, HR, BP, Borg Scale from all clinical sessions
Baseline and Week 12 measurements (performed on a separate days or prior to the sessions):
- Resting energy expenditure (REE)
- Body Composition [dual energy x-ray absorptiometry (DEXA) ) - [scans include total body, dual femur, and the knee], partial body potassium counting (PBKleg), bioelectrical impedance analysis (BIA), anthropometric and skin fold measurements]
- Fasting blood draw for plasma glucose and insulin (FPG, FPI), lipid profile, testosterone, sex hormone binding globulin (SHBG), insulin-like growth factor 1 (IGF-1), bone markers, coagulation factors, platelet aggregation, 2 hour standard oral glucose tolerance testing (OGTT) with insulin levels.
- Autonomic and blood pressure regulation studies [resting and tilt table provocation, for heart rate and blood pressure variability (HRV, BPV), arterial blood flow, and venous occlusion]
- Disability-specific quality of life (QOL) and activities of daily living surveys [GI-Bowel survey, brief pain inventory (BPI), fatigue survey, spasticity scale, mini mental status exam (MMSE)]. These disease-specific QOLs will include the question "How do you rate your general health and well-being over the past week?" A Lickert scale response will be incorporated.
- Functional Mobility Assessment
- Muscle biopsy for gene expression (subset of patients only).
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Stroke
- Keywords
- Lokomat, Suspended walking, Body Weight Supported, Treadmill Training
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
This pilot study for power calculations on future studies that will characterize the potential benefits of Lokomat rehabilitation training on cardiovascular function, body composition and endocrine/metabolic function
Measured: After completion of 24 clinical Lokomat rehabilitation sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startOct 2006
- Primary completionAug 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ann M. Spungen, EdD, Principal investigator, VA Medical Center, Bronx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883142
- Sponsor's protocol ID
- B4162C-11
- Status last verified
- Jun 2013
- First submitted
- 16 Apr 2009
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Physiological Responses to Lokomat Therapy (Pilot Study)
- ClinicalTrials.gov ID
- NCT00883142
- Acronym / sponsor ID
- B4162C-11
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Stroke
- Keywords
- Lokomat, Suspended walking, Body Weight Supported, Treadmill Training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2006
- Primary completion
- Aug 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 Apr 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.
Individuals with neurological deficiencies such as those who have spinal cord injury, stroke, traumatic brain injury, Parkinson's disease, and multiple sclerosis often lose their ability to ambulate over ground. Loss of functional mobility not only impedes everyday life, but may also affect many systems and organs in the body. The investigators are interested in obtaining a wide variety of data in order to obtain a better understanding of changes that occur as a result of receiving Lokomat therapy. The investigators will be studying body composition, cardiac, pulmonary, endocrine, metabolic, and molecular changes after a 12-week clinical therapy program.
Detailed description
Description of the Clinical Lokomat Therapy program:
This is a 12-week program with 3 to 5 sessions per week. Each session includes: 15-20 minutes of patient set-up (set-up time becomes about 5 to 10 minutes after a few sessions), 5-10 minutes of warm-up, 20-40 minutes of Lokomat therapy, 5-10 minutes of cool-down, and 5-10 minutes to remove the patient from the system. During the Lokomat sessions, heart rate and blood pressure are monitored by the therapist and recorded. Work performed is measured and recorded in the Lokomat computer for time, speed, amount of weight bearing, and distance.
Description of the Research Component:
A pre and post, prospective study design will be employed. Baseline measurements (Please see below and Table 1 for detailed descriptions) will be performed prior to start of the Lokomat therapy program and then again after completion of the 12-week program. A chart review will be performed at baseline only for documentation of medical history and medications. In a subset of patients a muscle biopsy will be performed for gene expression at baseline and week 12.
As part of Clinical Care, during each of the Lokomat therapy sessions the following information is collected:
- Work (total time, speed, distance, amount of weight bearing)
- Heart rate (HR)
- Blood Pressure (SBP, DBP)
- Perception of exertion (Borg Scale)
- Lipid profile (pre and post)
- Albumin (pre and post)
For Research purposes the following is being proposed:
Review and record work, HR, BP, Borg Scale from all clinical sessions
Baseline and Week 12 measurements (performed on a separate days or prior to the sessions):
- Resting energy expenditure (REE)
- Body Composition [dual energy x-ray absorptiometry (DEXA) ) - [scans include total body, dual femur, and the knee], partial body potassium counting (PBKleg), bioelectrical impedance analysis (BIA), anthropometric and skin fold measurements]
- Fasting blood draw for plasma glucose and insulin (FPG, FPI), lipid profile, testosterone, sex hormone binding globulin (SHBG), insulin-like growth factor 1 (IGF-1), bone markers, coagulation factors, platelet aggregation, 2 hour standard oral glucose tolerance testing (OGTT) with insulin levels.
- Autonomic and blood pressure regulation studies [resting and tilt table provocation, for heart rate and blood pressure variability (HRV, BPV), arterial blood flow, and venous occlusion]
- Disability-specific quality of life (QOL) and activities of daily living surveys [GI-Bowel survey, brief pain inventory (BPI), fatigue survey, spasticity scale, mini mental status exam (MMSE)]. These disease-specific QOLs will include the question "How do you rate your general health and well-being over the past week?" A Lickert scale response will be incorporated.
- Functional Mobility Assessment
- Muscle biopsy for gene expression (subset of patients only).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lokomat Rehabilitation Clinic
Key inclusion criteria (3 listed)
- The inclusion criteria are based on the guidelines set by the clinical Lokomat therapy program.
- Patients will have been evaluated on the Rehabilitation Service for entry into the clinical therapy program.
- Any patient who is already eligible for Lokomat therapy is a candidate for this research project.
Key exclusion criteria (12 listed)
- Pregnant women
- History of fractures of the lower extremities
- Bone density study indicating bone loss greater than 5 standard deviations from normal.
- Fixed contractures of the ankles, knees or hips
- Uncontrolled spasticity that significantly interferes with movement of lower extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
This pilot study for power calculations on future studies that will characterize the potential benefits of Lokomat rehabilitation training on cardiovascular function, body composition and endocrine/metabolic function
Time frame: After completion of 24 clinical Lokomat rehabilitation 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 11 Jun 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.
Ann M. Spungen, EdD principal investigator
VA Medical Center, Bronx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and 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 12 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 11 Jun 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.
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?
This pilot study for power calculations on future studies that will characterize the potential benefits of Lokomat rehabilitation training on cardiovascular function, body composition and endocrine/metabolic function (time frame: After completion of 24 clinical Lokomat rehabilitation 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 11 Jun 2013; AzTrials last refreshed its copy on 30 Oct 2026.