CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 53 enrolled
Drug / intervention
The Stride Management Assist (SMA) System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01994395
NCT01994395N/ACompleted

Randomized Control Trial Comparing Walking Task Specific Training With Stride Management Assist (SMA) Device vs.Functional Task Specific Training on Functional Walking Ability in Outpatient Stroke Rehabilitation

Shirley Ryan AbilityLab·interventional·Posted Nov 25, 2013·Updated Mar 27, 2020

In Brief

A clinical study evaluating The Stride Management Assist (SMA) System and Impairment based therapy for Stroke. Completed, enrolled 53 participants across 1 site.

Detailed Summary

Hypothesis/Specific Aims: The purpose of this study is to determine the effect of training with the Stride Management Assist (SMA) device vs. Impairment based physical therapy (IPT) on descending corticospinal drive to the lower limb muscles in patients post stroke. The investigators hypothesize that long-term SMA use would strengthen the connections between the motor areas of the brain and the lower limbs. Specifically, individuals in the SMA group will show higher corticospinal excitability of the lower limb muscles compared to those in the IPT group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States
CollaboratorsHonda

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 25, 2013
Enrollment StartOct 1, 2013
Primary CompletionFeb 1, 2020
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 12.6 years ago

Interventions

The Stride Management Assist (SMA) Systemdevice

Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.

Impairment based therapyother

Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training