Clinical Trials Logo

Clinical Trial Summary

The Myosuit is a light-weighted lower extremity soft exosuit which provide assistance during walking. In this study the Myosuit will be tested in the home and community setting in patients with incomplete spinal cord injury.


Clinical Trial Description

Rationale: People with incomplete spinal cord injury (iSCI) show often impairments and limitations related to gait, which negatively affects daily life gait performance (i.e. ambulation in home and community setting) and quality of life. As a consequence of limited gait capacity, these people are likely to develop a sedentary lifestyle resulting in a vicious circle, causing a further decline in gait capacity and daily life gait performance. One of the potential options to improve gait is the use of assistive technology, such as exoskeletons or exosuits. People with iSCI have voluntary control of the leg muscles may benefit more from light-weighted exosuits which provide assistance during walking. Recently, a lower extremity soft exosuit, the Myosuit (MyoSwiss AG), has been introduced. In a small sample study, participants showed an increased gait speed when using the Myosuit compared to their baseline gait speed. Moreover, only a small number of training sessions was required to use the Myosuit. Hence, the Myosuit seems to have a high potential to increase gait capacity and daily life gait performance in people with residual gait capacity. Objective: The study consists of two parts, randomized controlled trial (RCT) and experimental design. In the RCT, the primary objective is to test the efficacy of the Myosuit for increasing daily life gait performance in the home and community setting in people with iSCI. Secondary, the efficacy of the Myosuit program on gait capacity and its cost-utility will be investigated. Finally, the usability of the Myosuit for use in home and community setting will be evaluated. In the experimental design, we will investigate differences in gait capacity with and without wearing the Myosuit in people with iSCI, by conducting clinical tests. Secondary, differences in gait capacity measured on an instrumented treadmill with and without wearing the Myosuit will be examined. Study design: RCT and within subject experiment. Study population: Thirty-four people with chronic iSCI (>6 months after injury) and reduced gait capacity due to reduced knee and/or hip strength (MRC<5) will be recruited for this study. People with iSCI will be included when having an injury level of C or D on the American Spinal Injury Association Impairment Scale. In addition, participants need to have sufficient hand function to don and doff the Myosuit or they need a caregiver who is available to help the participant to use the Myosuit at home. Patients who have another (neurological) disease which can influence motor performance and/or patients who have small wounds, which can be worsened by wearing the Myosuit will be excluded. For the second objective of the experimental design, only people who are be able to walk consecutively for two minutes on a treadmill without any assistive device and without using the handrails will be included. Intervention: RCT: The intervention group will perform training sessions with the Myosuit at the Sint Maartenskliniek. Thereafter, they will receive the Myosuit at their disposal at home and a recommendation for physical activity for six weeks. The control group will receive a program of conventional physiotherapy at the Sint Maartenskliniek. Thereafter, they receive a recommendation for physical activity for at home for six weeks. Experimental design: Participants perform clinical tests and measurements on an instrumented treadmill with and without the Myosuit. Measurements intervention and control group: - Baseline: Week 1 (T0) - After clinical training program at the Sint Maartenskliniek: Week 5 (T1) - During 6 weeks home period: Week 6, 8, 11 (T2, T3, T4) - After the 6 weeks home period: Week 12 (T5) Additional measurements for the control group who receive the Myosuit intervention after the conventional program: - After clinical training program at the Sint Maartenskliniek: Week 16 (T6) - During 6 weeks home period: Week 17, 19, 22 (T7, T8, T9) - After the 6 weeks home period: Week 23 (T10) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05605912
Study type Interventional
Source Sint Maartenskliniek
Contact Lara Visch
Phone 024-3272701
Email la.visch@maartenskliniek.nl
Status Recruiting
Phase N/A
Start date October 3, 2022
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04102826 - Restoration of Arm Function in People With High-level Tetraplegia N/A
Recruiting NCT04052009 - Locomotor Training in Individuals With Incomplete Spinal Cord Injury. A Pilot Study N/A
Completed NCT01302522 - Mental Practice Impact on Gait and Cortical Organization in Spinal Cord Injury (SCI) Phase 2
Recruiting NCT05975606 - Non-invasive Brain Stimulation Paired With FES Cycling Post SCI N/A
Recruiting NCT04050696 - The Use of Electromagnetic Field (EMF) Treatment in Chronic Spinal Cord Injury (SCI) Patients N/A
Active, not recruiting NCT06079138 - Tele-rehabilitation Using tDCS Combined With Exercise in People With Spinal Cord Injury N/A
Recruiting NCT06214546 - Effect of Different Support Systems on Gait N/A
Completed NCT04340063 - Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury N/A
Recruiting NCT05142943 - Effectiveness of Virtual Bodily Illusion Intervention in Upper Limb Motor Function in People With Incomplete Spinal Cord Injury. N/A
Enrolling by invitation NCT05341466 - The Effect of Acute Intermittent Hypoxia on Motor Learning N/A
Completed NCT04910412 - Effects of tDCS With Gait Training on Leg Performance in Incomplete Spinal Cord Injury N/A
Recruiting NCT05726591 - Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders N/A
Recruiting NCT03057652 - Algorithmic-Based Evaluation and Treatment Approach for Robotic Gait Training N/A
Recruiting NCT05429736 - Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity N/A
Completed NCT01851629 - Walking Adaptability Post-Spinal Cord Injury N/A
Recruiting NCT01961557 - Evaluating a New Knee-Ankle-Foot Brace to Improve Gait in Children With Movement Disorders N/A
Recruiting NCT04977037 - A Telerehabilitation Program for SCI N/A
Active, not recruiting NCT04809987 - Effectiveness of Virtual Gait System Intervention in Motor Function in People With Incomplete Spinal Cord Injury. N/A
Not yet recruiting NCT06169657 - Comparison of Gait Training Methods in Sub-acute Stroke and Spinal Cord Injury
Not yet recruiting NCT05491837 - Effects of Intermittent Hypoxia in Upper and Lower Limb Functions in Persons With Incomplete Spinal Cord Injury N/A