Design and implementation
knee joints
CONTRACTIONS
This study is based on analyses as part of a randomized controlled trial (RCT) [The RCT was single blinded, with an assessor blinded to group allocation. Randomization was performed according to block randomization (prepared by a statistician not otherwise involved in the study, using the SAS system, including the variables: blocks of three, treatment and patient). A nurse not otherwise involved in the study randomized the participants after the baseline testing, by pulling the participant’s ID-number one by one from a prepared envelope and placing them in the order of the block starting at the top of each block. The result of the randomization was photographed and saved in the study file. Participants were randomized into three groups 1) One intervention group received gait training with the exoskeleton Hybrid Assistive Limb (HAL) as well as conventional gait and mobility training (HAL-group), 2) A second intervention group received conventional gait and mobility training (Conventional group), and 3) a control group, continued with their usual activities (Control group). The two intervention groups were dose-matched to out rule any variations in intensity and scheduled three times a week for six weeks, (18 sessions). In the HAL-group each session was scheduled for a maximum of 60 minutes of gait training with HAL, plus a maximum of 30 minutes of conventional gait and mobility training to enhance generalizability of the acquired skills to everyday life activities. The HAL was used on a treadmill with a safety harness including body weight support (pre-set to 9 kg) to unburden the weight of the HAL-suit. HAL can be individually set to support movements of the hip and knee joints and includes a hybrid system with a voluntary mode where the level of assistance is individually adjusted and triggered by muscle contractions detected by surface- electromyography (EMG) [