N/A
N=37
Comparison of Lokomat and Aquatic Exercise for Individuals With Chronic Incomplete Spinal Cord Injury
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01407354 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak — 17; 13; 17; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lokomat treadmill training (Device); Aquatic exercise therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak |
17; 13; 17; 12 | — |
| SECONDARY Number of Movement Recorded by Activity Monitor (SAM) |
61141; 82692 | 0.05 |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 ( 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
Data sourced from ClinicalTrials.gov (NCT01407354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.