Trial Outcomes & Findings for Machines Assisting Recovery From Stroke (NCT NCT02787694)

Last Updated: 2019-04-02

Results Overview

Overground 10 meter walk test consisting of three trials administered at baseline (pre-intervention) and at 10 weeks (post-intervention).

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

Baseline (pre-intervention) and 10 weeks (post-intervention)

Results posted on

2019-04-02

Participant milestones
Measure	Factor Targeted Walking Training Individuals undergo 5x 2 week periods of targeted training based upon evaluation of walking factor results Factor Targeted Walking Training: Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches treadmill
Overall Study STARTED	22
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	5

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Factor Targeted Walking Training n=17 Participants Individuals undergo 5x 2 week periods of targeted training based upon evaluation of walking factor results Factor Targeted Walking Training: Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches treadmill
Age, Categorical <=18 years	0 Participants n=17 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=17 Participants
Age, Categorical >=65 years	9 Participants n=17 Participants
Age, Continuous	56 years STANDARD_DEVIATION 12 • n=17 Participants
Sex: Female, Male Female	7 Participants n=17 Participants
Sex: Female, Male Male	10 Participants n=17 Participants
Region of Enrollment United States	17 Participants n=17 Participants
Overground walking speed Self-determined speed	0.65 m/sec STANDARD_DEVIATION 0.30 • n=17 Participants
Overground walking speed Fast walking speed	0.91 m/sec STANDARD_DEVIATION 0.49 • n=17 Participants

Timeframe: Baseline (pre-intervention) and 10 weeks (post-intervention)

Overground 10 meter walk test consisting of three trials administered at baseline (pre-intervention) and at 10 weeks (post-intervention).

Outcome measures
Measure	Factor Targeted Walking Training n=17 Participants Individuals undergo 5x 2 week periods of targeted training based upon evaluation of walking factor results Factor Targeted Walking Training: Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches treadmill
10 m Walk Test Pre-intervention	0.64 m/s Standard Deviation 0.32
10 m Walk Test Post-intervention	0.79 m/s Standard Deviation 0.30

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Factor Targeted Walking Training n=22 participants at risk Individuals undergo 5x 2 week periods of targeted training based upon evaluation of walking factor results Factor Targeted Walking Training: Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches treadmill
Injury, poisoning and procedural complications Cut to Finger	4.5% 1/22 • Number of events 1 • Through study completion (10 weeks) Participants were monitored for serious and non-serious adverse events according top the definition by clinicaltrials.gov throughout the study.

University of Alabama at Birmingham

Phone: 205-975-2788