Spinal Cord InjuryNCT01407354
Comparison of Lokomat and Aquatic Exercise for Individuals With Chronic Incomplete Spinal Cord Injury
A study testing Lokomat treadmill training and Aquatic exercise therapy in people with Spinal Cord Injury, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
Many people with spinal cord injury (SCI) hold some ability to move their leg muscles, and are therefore considered to demonstrate a motor incomplete injury. After such a spinal cord injury, individuals are able to walk less both in their home and in their community. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Lokomat treadmill training and Aquatic exercise therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Level of injury between C4 and T12 based on ASIA classification
- Chronic (greater than 12 months) spinal injury
- Completion of all conventional inpatient rehabilitation therapy
- Motor incomplete spinal cord injury (AIS C or D)
- Competency to provide informed consent
- Ability to tolerate a standing frame for at least 30 minutes
Who cannot join
- Currently performing aquatic therapy or Lokomat training as part of clinical care
- Complete or concurrent lower motor neuron injury as defined by the absence of reflexes bilaterally at the knees and the ankles
- Uncontrolled seizures
- Skin opening greater than 2 cm in diameter
- Alcohol consumption > 3 oz liquor, or 3 x 4oz of wine, or 36 oz of beer per day
- Cardiac history of (a) unstable angina, (b) recent (< 3 months) myocardial infarction, (c) congestive heart failure (NYHA category II), or (d) hemodynamically significant valvular dysfunction
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- Medical history of (a) recent hospitalization for severe disease or surgery, (b)undiagnosed diabetics (fasting glucose > 120) or poorly controlled diabetics (those not on a stable regimen for >6 months) unable to be controlled with medical treatment, (c) significant orthopedic or chronic pain conditions limiting exercise, (d) active neoplastic disease, (e) pulmonary or renal disease, and (f) presence of any serious medical condition with a prognosis for death or dependency in the next 2 months
- History of long bone fracture in the legs
- Frequent bouts of autonomic dysreflexia (as determined by the principal investigator)
- Any other medical co-morbidities that based on the judgment of the local principal investigator would preclude safe participation in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Shepherd Center, Virginia C. Crawford Research Institute
Atlanta, Georgia, 30309-1465
University of Maryland Rehabilitation & Orthopaedic Institute (formerly known as Kernan Hospital)
Baltimore, Maryland, 21207
About this study
Official title: Lokomat and Aquatic Therapy in Chronic Motor Incomplete Spinal Cord Injury
Many people with spinal cord injury (SCI) hold some ability to move their leg muscles, and are therefore considered to demonstrate a motor incomplete injury. After such a spinal cord injury, individuals are able to walk less both in their home and in their community. De-conditioning, or a lack of endurance and fitness also occurs. Several methods are available to try to improve walking ability and the fitness of persons with motor incomplete spinal cord injury. This study examines two of these methods. The first is the use of robotically assisted body-weight supported walking using a device called the Lokomat. The second is aquatic or pool-based exercise. The investigators are researching the impact of these two techniques on walking ability and fitness in people who experienced motor incomplete spinal cord injury for at least 12 months.
Read the detailed description
This research will occur in two centers Kernan Orthopedics and Rehabilitation Hospital in Baltimore, Maryland and Shepherd Center in Atlanta, Georgia. A total of 36 volunteers over a three year period are needed. In order to qualify for this study, individuals must be 18 to 65 years old with a motor incomplete SCI. The level of injury can range from the fourth cervical level in the neck to the twelfth thoracic level in the back. Potential volunteers must be able to tolerate standing in a standing frame for at least 30 minutes. Individuals will be assessed by a physician to determine their eligibility for the study and if participating in this type of exercise would be safe. Participants must be able to understand the study requirements and sign an informed consent document.
Participants will need to commit to a total of seven months. Included in this time is: testing, then the 3 months of exercise, testing, 2 week break, then the second 3 months of exercise, and a final testing. Half of the group will start with the Lokomat training and half will start wtih aquatic exercise. Each group will then switch to the other exercise condition. Exercise sessions will occur three times per week and last approximately 45-55 minutes. A physical therapist will provide personal direction for each of the exercise groups. Walking ability and cardiovascular fitness, as well as muscle strength will be assessed before starting exercise, at the three-month point and then at the six month point.
It is hoped that that this type of exercise therapy will help individuals with motor incomplete spinal injury both walk better and experience better heart-lung fitness and endurance. The risks associated with this type of study are similar to any type of cardiovascular exercise. In addition, individuals with spinal cord injury may present with some medical conditions, there may be other risks of the study. The physicians and therapists involved in the research will discuss these risks in detail with the individuals who enroll.
This type of research is important to better understand how best to prescribe exercise treatments to people with spinal injury. This is especially true with regards to aquatic therapy, since there is very little scientific data on its effect in this group of individuals. The rigorous assessment of aquatic exercise, which is already available in many communities, may expand the fitness opportunities for individuals with incomplete spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- Lokomat treadmill training, Aquatic exercise therapy
- Keywords
- robotic weight support, aquatic exercise, incomplete motor spinal cord injury, ASIA C and D
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat treadmill trainingDevice
Also called Robotic Body Weight Supported Locomotor Training
Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session
Aquatic exercise therapyOther
Also called Aquatic Therapy
Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session
| Study group | Role | What they receive |
|---|---|---|
| Lokomat Training | Experimental | Lokomat robotic assisted treadmill training Lokomat Treadmill Training Receives: Device: Lokomat treadmill training |
| Aquatic Therapy | Active comparator | Aquatic exercise therapy Receives: Other: Aquatic exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak
Peak VO2 via Arm Ergometer and Lokomat with metabolic cart
Measured: 7 months
Secondary outcomes (1)
Number of Movement Recorded by Activity Monitor (SAM)
SAM movements not just steps were gathered one time pre, crossover and post and worn on ankle for 5 days; percent change for each intervention
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Shepherd Center, Atlanta GA
- Responsible party
- Principal investigator, Peter Gorman, University of Maryland, Baltimore
- Investigators
- Paula R Geigle, PT, PhD, Principal investigator, University of Maryland Rehabilitation and Orthopaedic InstitutePeter H Gorman, MD, FAAN, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407354
- Sponsor's protocol ID
- HP-00047439
- Other IDs
- SC090147
- Status last verified
- May 2021
- First submitted
- 12 Jul 2011
- Last updated
- 26 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gorman PH, Scott W, VanHiel L, Tansey KE, Sweatman WM, Geigle PR. Comparison of peak oxygen consumption response to aquatic and robotic therapy in individuals with chronic motor incomplete spinal cord injury: a randomized controlled trial. Spinal Cord. 2019 Jun;57(6):471-481. doi: 10.1038/s41393-019-0239-7. Epub 2019 Jan 18.
PubMed 30659286
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lokomat and Aquatic Therapy in Chronic Motor Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01407354
- Acronym / sponsor ID
- HP-00047439
- Conditions
- Spinal Cord Injury
- Keywords
- robotic weight support, aquatic exercise, incomplete motor spinal cord injury, ASIA C and D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Shepherd Center, Atlanta GA
- Study start
- Apr 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Posted 8 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many people with spinal cord injury (SCI) hold some ability to move their leg muscles, and are therefore considered to demonstrate a motor incomplete injury. After such a spinal cord injury, individuals are able to walk less both in their home and in their community. De-conditioning, or a lack of endurance and fitness also occurs. Several methods are available to try to improve walking ability and the fitness of persons with motor incomplete spinal cord injury. This study examines two of these methods. The first is the use of robotically assisted body-weight supported walking using a device called the Lokomat. The second is aquatic or pool-based exercise. The investigators are researching the impact of these two techniques on walking ability and fitness in people who experienced motor incomplete spinal cord injury for at least 12 months.
Detailed description
This research will occur in two centers Kernan Orthopedics and Rehabilitation Hospital in Baltimore, Maryland and Shepherd Center in Atlanta, Georgia. A total of 36 volunteers over a three year period are needed. In order to qualify for this study, individuals must be 18 to 65 years old with a motor incomplete SCI. The level of injury can range from the fourth cervical level in the neck to the twelfth thoracic level in the back. Potential volunteers must be able to tolerate standing in a standing frame for at least 30 minutes. Individuals will be assessed by a physician to determine their eligibility for the study and if participating in this type of exercise would be safe. Participants must be able to understand the study requirements and sign an informed consent document.
Participants will need to commit to a total of seven months. Included in this time is: testing, then the 3 months of exercise, testing, 2 week break, then the second 3 months of exercise, and a final testing. Half of the group will start with the Lokomat training and half will start wtih aquatic exercise. Each group will then switch to the other exercise condition. Exercise sessions will occur three times per week and last approximately 45-55 minutes. A physical therapist will provide personal direction for each of the exercise groups. Walking ability and cardiovascular fitness, as well as muscle strength will be assessed before starting exercise, at the three-month point and then at the six month point.
It is hoped that that this type of exercise therapy will help individuals with motor incomplete spinal injury both walk better and experience better heart-lung fitness and endurance. The risks associated with this type of study are similar to any type of cardiovascular exercise. In addition, individuals with spinal cord injury may present with some medical conditions, there may be other risks of the study. The physicians and therapists involved in the research will discuss these risks in detail with the individuals who enroll.
This type of research is important to better understand how best to prescribe exercise treatments to people with spinal injury. This is especially true with regards to aquatic therapy, since there is very little scientific data on its effect in this group of individuals. The rigorous assessment of aquatic exercise, which is already available in many communities, may expand the fitness opportunities for individuals with incomplete spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lokomat Training | Experimental | Device: Lokomat treadmill trainingLokomat robotic assisted treadmill training Lokomat Treadmill Training |
| Aquatic Therapy | Active comparator | Other: Aquatic exercise therapyAquatic exercise therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-65 years
- Level of injury between C4 and T12 based on ASIA classification
- Chronic (greater than 12 months) spinal injury
- Completion of all conventional inpatient rehabilitation therapy
- Motor incomplete spinal cord injury (AIS C or D)
Key exclusion criteria (10 listed)
- Currently performing aquatic therapy or Lokomat training as part of clinical care
- Complete or concurrent lower motor neuron injury as defined by the absence of reflexes bilaterally at the knees and the ankles
- Uncontrolled seizures
- Skin opening greater than 2 cm in diameter
- Alcohol consumption > 3 oz liquor, or 3 x 4oz of wine, or 36 oz of beer per day
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 treadmill trainingAlso: Robotic Body Weight Supported Locomotor TrainingLokomat treadmill training: 12 wks, 3x/wk, 45 mins@session | Device | Lokomat Training |
| Aquatic exercise therapyAlso: Aquatic TherapyAquatic exercise training: 12 wks, 3x/wk, 45 mins@session | Other | Aquatic Therapy |
Primary outcome
Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak
Time frame: 7 months
Peak VO2 via Arm Ergometer and Lokomat with metabolic cart
1 secondary outcome
Number of Movement Recorded by Activity Monitor (SAM)
Time frame: 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30659286Gorman PH, Scott W, VanHiel L, Tansey KE, Sweatman WM, Geigle PR. Comparison of peak oxygen consumption response to aquatic and robotic therapy in individuals with chronic motor incomplete spinal cord injury: a randomized controlled trial. Spinal Cord. 2019 Jun;57(6):471-481. doi: 10.1038/s41393-019-0239-7. Epub 2019 Jan 18.
- 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.
Paula R Geigle, PT, PhD principal investigator
University of Maryland Rehabilitation and Orthopaedic Institute
Peter H Gorman, MD, FAAN principal investigator
University of Maryland, Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lokomat treadmill training and Aquatic exercise therapy in people with Spinal Cord Injury, run by University of Maryland, Baltimore at 2 sites 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 7 inclusion and 10 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 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 8 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407354, which also lists 1 linked publication.
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 26 May 2021.