Effect of an exosuit on daily life gait performance in individuals with incomplete spinal cord injury: a randomized controlled trial.

The trial was open-label: participants and treating physical therapists knew which program they received, and the outcome assessor was not blinded. It was conducted at one centre, and participants had to be able to walk 10 m and don the device or have a caregiver, so results may not apply to people with more severe walking limitation. The trial compared whole programs, so the effect of the exosuit alone cannot be separated from training, device-learning time, and usual care. Primary walking-time data were incomplete for some assessments; days were averaged from available complete days rather than always seven full days. Missing data were handled by using the last available measurement, which can bias repeated daily walking estimates. Two intervention-group participants stopped because of pain, and device errors interrupted use, so the null result may reflect poor usability or reliability rather than a pure lack of effect. Home use was recorded in logbooks rather than device data, and participants may have been selected for technology interest. The population was heterogeneous, and secondary analyses did not identify characteristics that predicted response. Cost and quality-of-life comparisons were descriptive and not powered for statistical comparison.

ZonMw is named as funder.

Do not conclude that the exosuit alone caused no benefit. Both groups received physical-therapist training and usual care, and the Myosuit group also learned device operation, so the trial compares whole programs, not the exosuit in isolation. Intervention-group participants used the Myosuit 2.7 times per week on average and reported marginal usability.