Comparison of high-intensive and low-intensive electromechanical-assisted gait training by Exowalk® in patients over 3-month post-stroke.

BACKGROUND: This study was conducted to assess the effect of electromechanical-assisted gait training intensity on walking ability in patients over 3-month post-stroke.

METHODS: Data from two randomized controlled trials (RCTs) were collected under the same study design of assessment and intervention, excluding intervention time per session. After matching the inclusion criteria of two RCTs, the experimental groups of each RCT were defined as low-intensive (LI) and high-intensive (HI) group according to the intervention time per session. Primary outcome was the difference of the change in Functional Ambulatory Categories (FAC) between LI and HI gait training. Secondary outcomes were the difference of changes in mobility, walking speed, walking capacity, leg-muscle strength, balance and daily activity evaluated with Rivermead Mobility Index (RMI), 10 m walk test (10MWT), 6-min walk test (6MWT), Motricity Index (MI), Berg Balance Scale (BBS) and Modified Barthel Index (MBI) respectively.

RESULTS: The FAC improved after gait training in both groups. The secondary outcomes also improved in both groups except RMI and MI in HI group. The change of all outcomes were not different between groups except RMI. The change of RMI in the LI group was greater than that in the HI group statistically, but it did not meet minimal clinically important difference.

CONCLUSIONS: The improvement of walking ability after LI or HI gait training was not different if providing the same total gait training time. By providing the electromechanical gait training intensively, we could shorten the gait training period to improve walking ability and customize the training program according to the patient training abilities.

TRIAL REGISTRATION: Name of the registry: Clinical Research Information Service.

TRIAL REGISTRATION NUMBER: No. KCT0002195(RCT1), No. KCT0002552(RCT2). Date of registration: 10/04/2016(RCT1), 10/05/2017(RCT2). URL of the trial registry record: https://cris.nih.go.kr/cris/search.