Trial Outcomes & Findings for Comparison of Lokomat and Aquatic Exercise for Individuals With Chronic Incomplete Spinal Cord Injury (NCT NCT01407354)
NCT ID: NCT01407354
Last Updated: 2021-05-26
Results Overview
Peak VO2 via Arm Ergometer and Lokomat with metabolic cart
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
7 months
Results posted on
2021-05-26
Participant Flow
Clinicaltrial.gov, facility IRB approved SCI database, medical community all helped recruit for this study
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
First Intervention
STARTED
|
20
|
17
|
|
First Intervention
COMPLETED
|
18
|
15
|
|
First Intervention
NOT COMPLETED
|
2
|
2
|
|
Second Intervention
STARTED
|
18
|
15
|
|
Second Intervention
COMPLETED
|
18
|
13
|
|
Second Intervention
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
0
|
2
|
|
First Intervention
Adverse Event
|
1
|
0
|
|
First Intervention
Physician Decision
|
1
|
0
|
Baseline Characteristics
Comparison of Lokomat and Aquatic Exercise for Individuals With Chronic Incomplete Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
All Study Participants
n=37 Participants
Baseline data reflects all participants who received both aquatic exercise and lokomat training during the study.
|
|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 monthsPeak VO2 via Arm Ergometer and Lokomat with metabolic cart
Outcome measures
| Measure |
Lokomat Training
n=31 Participants
Lokomat robotic assisted treadmill training Lokomat Treadmill Training
Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session
|
Aquatic Therapy
n=33 Participants
Aquatic exercise therapy
Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session
|
|---|---|---|
|
Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak
Number of participants with 10% changePeak VO2 Arm
|
17 participants
|
13 participants
|
|
Number of Participants Demonstrating 10% Change: Arm Ergometer and Lokomat Metabolic Cart VO2 Peak
number participants with 10% changPeak VO2 lokomat
|
17 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 7 monthsSAM movements not just steps were gathered one time pre, crossover and post and worn on ankle for 5 days; percent change for each intervention
Outcome measures
| Measure |
Lokomat Training
n=31 Participants
Lokomat robotic assisted treadmill training Lokomat Treadmill Training
Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session
|
Aquatic Therapy
n=33 Participants
Aquatic exercise therapy
Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session
|
|---|---|---|
|
Number of Movement Recorded by Activity Monitor (SAM)
|
61141 number of movements
Standard Deviation 1823
|
82692 number of movements
Standard Deviation 1785
|
Adverse Events
Lokomat Training
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Aquatic Therapy
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lokomat Training
n=37 participants at risk
Lokomat robotic assisted treadmill training Lokomat Treadmill Training
Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session
|
Aquatic Therapy
n=37 participants at risk
Aquatic exercise therapy
Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session
|
|---|---|---|
|
Nervous system disorders
Autonomic Dysreflexia
|
2.7%
1/37
|
0.00%
0/37
|
|
Nervous system disorders
parasthesia
|
2.7%
1/37
|
0.00%
0/37
|
|
Blood and lymphatic system disorders
medical instability
|
0.00%
0/37
|
2.7%
1/37
|
Additional Information
Paula Richley Geigle PT PhD
University Maryland Rehabilitation and Orthopaedic Institute
Phone: 410 448 6773
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place