N/A N=35 Randomized Treatment

Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)

Paraplegia · Quadriplegia · Spinal Cord Injury · Tetraplegia

Bottom Line

View on ClinicalTrials.gov: NCT00385918 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

May 2014

Primary outcome: Primary: Cardiovascular Fitness as Determined by Lokomat Peak VO2 Assessments — 20.2; 12.9; 22.5; 11.6 ml/kg/min

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lokomat Training (Device); Home stretching then Lokomat training (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Jun 2011

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	—

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

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

View full record on ClinicalTrials.gov →

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.