An interventional study of Control and Myosuit in Incomplete Spinal Cord Injury, sponsored by Sint Maartenskliniek. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Sint Maartenskliniek · Not applicable, Interventional, and Treatment
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.
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:
Additional measurements for the control group who receive the Myosuit intervention after the conventional program:
Sint Maartenskliniek is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants perform Myosuit training sessions. After the clinical Myosuit training program, participants receive the Myosuit at their disposal at home for six weeks and a recommendation for physical activity at home.
Device: Myosuit
Participants perform conventional training sessions. After the clinical training program, participants receive a recommendation for physical activity at home. After the conventional training program the control group will receive the Myosuit intervention.
Other: Control · Device: Myosuit
Participants perform five one-hour conventional training sessions at the Sint Maartenskliniek in which they perform functional exercises. After the conventional training program, the control group will receive a recommendation for physical activity at home for six weeks.
Participants perform five one-hour Myosuit training sessions at the Sint Maartenskliniek in which they perform functional exercises and learn to don, doff and use the device for standing, walking, climbing the stairs and sit-to-stand transitions. After the clinical Myosuit training program, participants receive the Myosuit at their disposal at home and a recommendation for physical activity at home for six weeks.
Also known as: Myoswiss
Change from baseline daily life gait performance to the home period as assessed by walking time per day (minutes)
Measured by the Activ8 for 7 days. At baseline (T0) 7 days are averaged to calculate mean walking time per day. During the 6-week home period all days are averaged to calculate mean walking time per day. (RCT)
Time frame: Baseline: Week 1 (T0), During the 6-week home period: average over week 6, 8, 11 (T2, T3, T4)
Change in preferred walking speed between with and without Myosuit as assessed by the 10 meter walk test (m/s)
Measure for gait capacity. (experimental design)
Time frame: After the clinical training program: Week 5 (Myosuit intervention, T1) or week 16 (Control, T6)
Daily life gait performance as assessed by gait quality
Measured by inertial measurement units. (RCT)
Time frame: Baseline: Week 1 (T0), During the 6-week home period: week 6 and 11 (T2, T4) and week 17 and 22 (T7, T9)
Change from baseline preferred walking speed at T5 as assessed by the 10 meter walk test (m/s)
Measure for gait capacity. (RCT)
Time frame: Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Maximum walking speed as assessed by the 10 meter walk test (m/s)
Measure for gait capacity. (RCT)
Time frame: Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Walking speed as assessed by the 6 minutes walk test (m/s)
Measure for gait capacity. (RCT)
Time frame: Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Functional ambulation as assessed by the spinal cord injury functional ambulation profile (SCI-FAP)
Measure for gait capacity. The SCI-FAP is composed of 7 tasks: carpet, up \& go, obstacles, stairs, carry, step, and door. The highest total score is 2100. The SCI-FAP is a timed measure, a low score indicates better function. (RCT)
Time frame: Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Usability as assessed by the System Usability Scale (SUS)
The range is between 0 and 100, with a higher score indicating better usability. (RCT)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6), After the 6-week home period: Week 12 and 23 (T5, T10)
Usability as assessed by the Dutch version of the quebec user evaluation of satisfaction with assistive technology (D-QUEST)
The range is between 1 and 5, with a higher score indicating greater satisfaction. (RCT)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6), After the 6-week home period: Week 12 and 23 (T5, T10)
Quality-adjusted-life years gain assessed by EuroQol five-dimension scale questionnaire (EQ5D-5L)
Measure for quality of life to investigate cost-utility. The EQ5D-5L consists of five levels with a maximum score of 1 which indicates the best health state. In addition there is a visual analogue scale with a maximum score of 100 to indicate general health status. (RCT)
Time frame: Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
General and Disease Specific Self-efficacy Scale
Questionnaire contains confidence in general, confidence in managing with your physical condition and confidence in walking. The range is between 0 and 160, with a higher score indicating higher confidence. (RCT)
Time frame: Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Maximum walking speed as assessed by the 10 meter walk test (m/s)
Measure for gait capacity. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Walking speed as assessed by the 6 minutes walk test (m/s)
Measure for gait capacity. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Preferred walking speed as assessed by walking on the GRAIL (m/s)
Measure for gait capacity. Preferred walking speed is measured during 2 minutes self-paced walking on the GRAIL. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Step length as assessed by walking on the GRAIL
Measure for gait capacity. Step length is measured during 2 minutes walking on fixed speed on the GRAIL. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Step time as assessed by walking on the GRAIL
Measure for gait capacity. Step time is measured during 2 minutes walking on fixed speed on the GRAIL. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Ankle range of motion as assessed by walking on the GRAIL
Measure for gait capacity. Ankle range of motion is measured during 2 minutes walking on fixed speed on the GRAIL. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Maximum ankle plantar flexion as assessed by walking on the GRAIL
Measure for gait capacity. Maximum ankle plantar flexion is measured during 2 minutes walking on fixed speed on the GRAIL. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Knee range of motion as assessed by walking on the GRAIL
Measure for gait capacity. Knee range of motion is measured during 2 minutes walking on fixed speed on the GRAIL. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Maximum knee extension as assessed by walking on the GRAIL
Measure for gait capacity. Maximum knee extension is measured during 2 minutes walking on fixed speed on the GRAIL. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Hip range of motion as assessed by walking on the GRAIL
Measure for gait capacity. Hip range of motion is measured during 2 minutes walking on fixed speed on the GRAIL. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Maximum hip extension as assessed by walking on the GRAIL
Measure for gait capacity. Maximum hip extension is measured during 2 minutes walking on fixed speed on the GRAIL. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Variable error of the precision stepping task as assessed by walking on the GRAIL
Measure for gait adaptability. (experimental design)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Sex (man/woman)
Descriptive outcome measure.
Time frame: Baseline: Week 1 (T0)
Age (years)
Descriptive outcome measure.
Time frame: Baseline: Week 1 (T0)
Height (cm)
Descriptive outcome measure.
Time frame: Baseline: Week 1 (T0)
Weight (kg)
Descriptive outcome measure.
Time frame: Baseline: Week 1 (T0)
Body Mass Index
Descriptive outcome measure. Calculated with weight and height.
Time frame: Baseline: Week 1 (T0)
Time since spinal cord injury (years)
Descriptive outcome measure.
Time frame: Baseline: Week 1 (T0)
Spinal cord injury classification defined by the American Spinal Injury Association (ASIA) impairment scale (C or D)
Descriptive outcome measure. The scale has five classification levels (A-E), ranging from complete loss of neural function (A) in the affected area to completely normal (E).
Time frame: Baseline: Week 1 (T0)
Level of spinal cord injury
Descriptive outcome measure. There are four sections that impact the level of spinal cord injury: cervical, thoracic, lumbar and sacral.
Time frame: Baseline: Week 1 (T0)
Muscle strength as assessed by Medical Research Council (MRC) scale
Descriptive outcome measure. Range from 0 - 5 with higher scores indicating more strength
Time frame: Baseline: Week 1 (T0)
Spasticity as assessed by Modified Ashworth Scale (MAS)
Descriptive outcome measure. Range from 0 - 4 with higher scores indicating more spasticity
Time frame: Baseline: Week 1 (T0)
Sensory function as assessed by the American Spinal Cord Injury Association (ASIA) Impairment Scale
Descriptive outcome measure. Range from 0 - 2 with lower scores indicating more impaired sensory function
Time frame: Baseline: Week 1 (T0)
Plan to share: No
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