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| ID | Type | Description | Link |
|---|---|---|---|
| SC090147 |
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| Name | Class |
|---|---|
| Shepherd Center, Atlanta GA | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lokomat Training | Experimental | Lokomat robotic assisted treadmill training Lokomat Treadmill Training |
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| Aquatic Therapy | Active Comparator | Aquatic exercise therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lokomat treadmill training | Device | Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak | Peak VO2 via Arm Ergometer and Lokomat with metabolic cart | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula R Geigle, PT, PhD | University of Maryland Rehabilitation and Orthopaedic Institute | Principal Investigator |
| Peter H Gorman, MD, FAAN | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shepherd Center, Virginia C. Crawford Research Institute | Atlanta | Georgia | 30309-1465 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30659286 | Derived | 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. |
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Randomized Controlled Trial (which arm to initiate study) cross over design with no wash out period between arms. Adjusted statistically for change in each arm and arm participation order.
Clinicaltrial.gov, facility IRB approved SCI database, medical community all helped recruit for this study
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| ID | Title | Description |
|---|---|---|
| FG000 | Lokomat First Then Aquatic Exercise | Lokomat robotic assisted treadmill training Lokomat Treadmill Training Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session, participants received aquatic exercise after lokomat |
| FG001 | Aquatic Therapy First Then Lokomat Intervention | Aquatic exercise therapy Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session, participants received lokomat intervention after aquatic exercise |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Baseline data reflects all participants who received both aquatic exercise and lokomat training during the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak | Peak VO2 via Arm Ergometer and Lokomat with metabolic cart | Posted | Number | participants | 7 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lokomat Training | Lokomat robotic assisted treadmill training Lokomat Treadmill Training Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Autonomic Dysreflexia | Nervous system disorders | inappropriate blood pressure response to exercise |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paula Richley Geigle PT PhD | University Maryland Rehabilitation and Orthopaedic Institute | 410 448 6773 | pgeigle@umm.edu |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000088543 | Aquatic Therapy |
| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Aquatic exercise therapy | Other | Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session |
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| University of Maryland Rehabilitation & Orthopaedic Institute (formerly known as Kernan Hospital) |
| Baltimore |
| Maryland |
| 21207 |
| United States |
| Physician Decision |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | 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 | Posted | Mean | Standard Deviation | number of movements | 7 months |
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| 0 |
| 37 |
| 2 |
| 37 |
| EG001 | Aquatic Therapy | Aquatic exercise therapy Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session | 0 | 37 | 1 | 37 |
| parasthesia | Nervous system disorders | pins and needles in non distribution pattern reported |
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| medical instability | Blood and lymphatic system disorders | unstable blood pressure unrelated to aquatic intervention. participant returned to primary care to stabilize medical condition unrelated to study...... |
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| D014947 | Wounds and Injuries |
| 0.024 |
| Superiority or Other (legacy) |