Trial Outcomes & Findings for Improving Ambulation Post Stroke With Robotic Training (NCT NCT00975156)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

Results posted on

2013-02-25

Participant milestones
Measure	Lokomat Intervention	Standard of Care Conventional physical therapy
Overall Study STARTED	11	10
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal
Measure	Lokomat Intervention	Standard of Care Conventional physical therapy
Overall Study Protocol Violation	0	1

Improving Ambulation Post Stroke With Robotic Training

Baseline characteristics by cohort
Measure	Lokomat Intervention n=11 Participants	Standard of Care n=10 Participants Conventional physical therapy	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants	5 Participants n=4 Participants	9 Participants n=27 Participants
Age, Categorical >=65 years	7 Participants n=93 Participants	5 Participants n=4 Participants	12 Participants n=27 Participants
Age Continuous	66.91 years STANDARD_DEVIATION 8.50 • n=93 Participants	64.33 years STANDARD_DEVIATION 10.91 • n=4 Participants	65.75 years STANDARD_DEVIATION 9.48 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants
Region of Enrollment United States	11 participants n=93 Participants	10 participants n=4 Participants	21 participants n=27 Participants

Timeframe: Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

Population: Analysis was determined per protocol (i.e.between-group variation)

Outcome measures
Measure	Lokomat Intervention 10-meter Walking Test (10mWT) Outcome n=11 Participants Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.	Standard of Care 10mWT Outcome n=9 Participants Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.	All Participants 10mWT Outcome n=20 Participants Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
10-meter Walking Test (10mWT) Baseline	0.20 meters per second (m/s) Standard Deviation 0.10	0.18 meters per second (m/s) Standard Deviation 0.12	0.19 meters per second (m/s) Standard Deviation 0.11
10-meter Walking Test (10mWT) Post-Intervention (mean=5.05 days post-therapy)	0.20 meters per second (m/s) Standard Deviation 0.10	0.27 meters per second (m/s) Standard Deviation 0.27	0.23 meters per second (m/s) Standard Deviation 0.19
10-meter Walking Test (10mWT) Three-Month Follow-up	0.21 meters per second (m/s) Standard Deviation 0.10	0.28 meters per second (m/s) Standard Deviation 0.29	0.24 meters per second (m/s) Standard Deviation 0.20

Timeframe: Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention

Outcome measures
Measure	Lokomat Intervention 10-meter Walking Test (10mWT) Outcome n=11 Participants Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.	Standard of Care 10mWT Outcome n=9 Participants Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.	All Participants 10mWT Outcome n=20 Participants Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
6 Minute Walking Distance (6MWD) Baseline	53.94 meters (m) Standard Deviation 30.53	48.77 meters (m) Standard Deviation 21.04	51.61 meters (m) Standard Deviation 26.16
6 Minute Walking Distance (6MWD) Post-Intervention (mean=5.05 days post-therapy)	57.02 meters (m) Standard Deviation 25.50	70.26 meters (m) Standard Deviation 60.40	62.98 meters (m) Standard Deviation 43.86
6 Minute Walking Distance (6MWD) Three-Month Follow-up	57.82 meters (m) Standard Deviation 25.99	76.89 meters (m) Standard Deviation 62.29	66.40 meters (m) Standard Deviation 45.65

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events
Measure	Lokomat Intervention n=11 participants at risk Robotic-assisted gait therapy	Standard of Care n=9 participants at risk Conventional physical therapy
Skin and subcutaneous tissue disorders Skin breakdown	9.1% 1/11 • Number of events 1	0.00% 0/9
Cardiac disorders Hypotensive episode	0.00% 0/11	11.1% 1/9 • Number of events 1
Cardiac disorders Chest pain	0.00% 0/11	11.1% 1/9 • Number of events 1
Vascular disorders Stroke	9.1% 1/11 • Number of events 1	0.00% 0/9

Other adverse events
Measure	Lokomat Intervention n=11 participants at risk Robotic-assisted gait therapy	Standard of Care n=9 participants at risk Conventional physical therapy
Skin and subcutaneous tissue disorders Minor skin breakdown	45.5% 5/11 • Number of events 12	33.3% 3/9 • Number of events 3

Mischer Neuroscience Institute, Memorial Hermann-TMC