N/A
Completed N=35
Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)
Paraplegia · Quadriplegia · Spinal Cord Injury · Tetraplegia
Source: ClinicalTrials.gov NCT00385918 ↗
Enrolled (actual)
35
Serious AEs
4.8%
Results posted
May 2014
Primary outcomePrimary: Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments — 20.2; 12.9; 22.5; 11.6 ml/kg/min
Summary
This proposal investigates the hypothesis that progressive aerobic exercise with Lokomat is feasible in people with motor incomplete spinal cord injury, and three months of training will improve cardiovascular fitness and gait functionality when compared to physical therapy controls
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments |
20.2; 12.9; 22.5; 11.6; 22.7; 13.4 | — |
| PRIMARY Cardiovascular Fitness as Determined by Arm Cycle Ergometry VO2 Peak Assessments. |
20.0; 13.5; 19.8; 11.1; 21.7; 13.7 | — |
| SECONDARY Body Mass |
80.8; 94.3; 79.8; 92.3; NA; 93.4 | — |
| SECONDARY Percent Body Fat |
33.6; 34.2; 32.4; 33.3; NA; 33.3 | — |
| SECONDARY Lean Muscle Mass |
51.2; 58.9; 51.4; 58.3; NA; 59.0 | — |
| SECONDARY Bone Mineral Content |
3.04; 3.18; 3.02; 3.16; NA; 3.17 | — |
| SECONDARY Six Minute Walk |
179.5; 203.0; 201.6; 250.8 | — |
| SECONDARY 10-meter Walk |
23.0; 16.5; 21.3; 14.6 | — |
| SECONDARY Step Activity Monitor |
1674.8; 1531.3; 1579.9; 1652.4 | — |
Eligibility Criteria
Inclusion Criteria
- Acute onset Spinal Cord Injury or Disease at least 12 months prior to enrollment
- Age 18 to 80
- Level of injury from C4 to L2
- ASIA impairment scale either C or D
- Able to tolerate standing frame for at least 30 minutes
Exclusion Criteria
- History of unstable angina, recent MI (myocardial infarction), CHF (congestive heart failure) or clinically significant valvular dysfunction
- History of recent hospitalization (<3 months) for a major medical problem
Data sourced from ClinicalTrials.gov (NCT00385918). 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. Informational only — not medical advice.