Incomplete Spinal Cord InjuryNCT05605912
Myosuit in Incomplete Spinal Cord Injury
A study testing Myosuit in people with Incomplete Spinal Cord Injury, run by Sint Maartenskliniek at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incomplete Spinal Cord Injury
- What is being tested?
- Myosuit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 Oct 2022to 21 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People with a stable chronic iSCI (>6 months after injury).
- Having an injury level of C or D on the American Spinal Injury Association Impairment Scale.
- Age ≥ 18 years.
- Need to have sufficient hand function and standing balance to don and doff the Myosuit or they need a caregiver who is available to help the participant to use the Myosuit at home.
- Having reduced gait capacity due to reduced knee and/or hip strength (MRC=<4).
- Must be able to stand up from a chair without deviating to the left or right side for more than 45 degrees during the movement.
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- Can walk for 10 meter without the assistance of another person but can be assisted by assistive devices except knee orthoses.
- People aim to improve walking distance, walking speed or gait capacity.
- Sufficient postural control to walk independently (i.e. without assistance of a person, assistive devices are allowed).
- For the second objective of part B of this study, 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
Who cannot join
- Have another (neurological) disease which can influence motor performance.
- Have wounds which can be worsened by wearing the Myosuit will be excluded.
- Taller than 195 and smaller than 150 cm.
- Body weight of more than 110 kg or less than 45 kg.
- Pregnancy.
- Insufficient mastery of the Dutch language
Show all 11Show fewer
- Psychiatric background.
- Flexion contracture in knee or hip in excess of 10 degrees.
- Knee varus malposition in excess of 10 degrees or knee valgus malposition in excess of 10 degrees.
- Oncological spinal cord injury.
- Unsuitable for participation according to the rehabilitation physician or researcher.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Myosuit for Increasing Daily Life Gait Performance in the Home and Community Setting and Gait Capacity in People With Incomplete Spinal Cord Injury
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.
Read the detailed 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)
- Conditions
- Incomplete Spinal Cord Injury
- Being tested
- Control, Myosuit
- Keywords
- Myosuit, Exosuit, Rehabilitation, Walking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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.
MyosuitDevice
Also called Myoswiss
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.
| Study group | Role | What they receive |
|---|---|---|
| Myosuit intervention | Experimental | 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. Receives: Device: Myosuit |
| Control | Active comparator | 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. Receives: Other: Control; Device: Myosuit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: After the clinical training program: Week 5 (Myosuit intervention, T1) or week 16 (Control, T6)
Secondary outcomes (21)
Daily life gait performance as assessed by gait quality
Measured by inertial measurement units. (RCT)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: After the clinical training program: Week 5 and 16 (T1, T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start3 Oct 2022
- Primary completion21 Aug 2025
- Study completion21 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Keijsers, Sint Maartenskliniek
- Investigators
- Bart van den Bemt, Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05605912
- Sponsor's protocol ID
- 1033
- Other IDs
- NL80641.091.22
- Status last verified
- Feb 2026
- First submitted
- 19 Oct 2022
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balasubramanian CK, Clark DJ, Fox EJ. Walking adaptability after a stroke and its assessment in clinical settings. Stroke Res Treat. 2014;2014:591013. doi: 10.1155/2014/591013. Epub 2014 Aug 28.
PubMed 25254140DiPiro ND, Holthaus KD, Morgan PJ, Embry AE, Perry LA, Bowden MG, Gregory CM. Lower Extremity Strength Is Correlated with Walking Function After Incomplete SCI. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):133-9. doi: 10.1310/sci2102-133. Epub 2015 Apr 12.
PubMed 26364282Fanchamps MHJ, Horemans HLD, Ribbers GM, Stam HJ, Bussmann JBJ. The Accuracy of the Detection of Body Postures and Movements Using a Physical Activity Monitor in People after a Stroke. Sensors (Basel). 2018 Jul 5;18(7):2167. doi: 10.3390/s18072167.
PubMed 29976900Haufe FL, Kober AM, Schmidt K, Sancho-Puchades A, Duarte JE, Wolf P, Riener R. User-driven walking assistance: first experimental results using the MyoSuit. IEEE Int Conf Rehabil Robot. 2019 Jun;2019:944-949. doi: 10.1109/ICORR.2019.8779375.
PubMed 31374751Haufe FL, Schmidt K, Duarte JE, Wolf P, Riener R, Xiloyannis M. Activity-based training with the Myosuit: a safety and feasibility study across diverse gait disorders. J Neuroeng Rehabil. 2020 Oct 8;17(1):135. doi: 10.1186/s12984-020-00765-4.
PubMed 33032627Horemans H, Kooijmans H, van den Berg-Emons R, Bussmann H. The Activ8 activity monitor: Validation of posture and movement classification. J Rehabil Assist Technol Eng. 2020 Mar 16;7:2055668319890535. doi: 10.1177/2055668319890535. eCollection 2020 Jan-Dec.
PubMed 32206335Ishikawa S, Stevens SL, Kang M, Morgan DW. Reliability of daily step activity monitoring in adults with incomplete spinal cord injury. J Rehabil Res Dev. 2011;48(10):1187-94. doi: 10.1682/jrrd.2010.09.0190.
PubMed 22234663Just IA, Fries D, Loewe S, Falk V, Cesarovic N, Edelmann F, Feuerstein A, Haufe FL, Xiloyannis M, Riener R, Schoenrath F. Movement therapy in advanced heart failure assisted by a lightweight wearable robot: a feasibility pilot study. ESC Heart Fail. 2022 Jun;9(3):1643-1650. doi: 10.1002/ehf2.13903. Epub 2022 Mar 23.
PubMed 35320878Lankhorst K, van den Berg-Emons RJ, Bussmann JBJ, Horemans HLD, de Groot JF. A Novel Tool for Quantifying and Promoting Physical Activity in Youths With Typical Development and Youths Who Are Ambulatory and Have Motor Disability. Phys Ther. 2019 Mar 1;99(3):354-363. doi: 10.1093/ptj/pzy152.
PubMed 30649497Maetzler W, Rochester L, Bhidayasiri R, Espay AJ, Sanchez-Ferro A, van Uem JMT. Modernizing Daily Function Assessment in Parkinson's Disease Using Capacity, Perception, and Performance Measures. Mov Disord. 2021 Jan;36(1):76-82. doi: 10.1002/mds.28377. Epub 2020 Nov 15.
PubMed 33191498Muthukrishnan N, Abbas JJ, Krishnamurthi N. A Wearable Sensor System to Measure Step-Based Gait Parameters for Parkinson's Disease Rehabilitation. Sensors (Basel). 2020 Nov 10;20(22):6417. doi: 10.3390/s20226417.
PubMed 33182658Mohamed Refai MI, van Beijnum BF, Buurke JH, Veltink PH. Portable Gait Lab: Tracking Relative Distances of Feet and CoM Using Three IMUs. IEEE Trans Neural Syst Rehabil Eng. 2020 Oct;28(10):2255-2264. doi: 10.1109/TNSRE.2020.3018158. Epub 2020 Aug 20.
PubMed 32816676Saraf P, Rafferty MR, Moore JL, Kahn JH, Hendron K, Leech K, Hornby TG. Daily stepping in individuals with motor incomplete spinal cord injury. Phys Ther. 2010 Feb;90(2):224-35. doi: 10.2522/ptj.20090064. Epub 2009 Dec 18.
PubMed 20022997Schmidt K, Duarte JE, Grimmer M, Sancho-Puchades A, Wei H, Easthope CS, Riener R. The Myosuit: Bi-articular Anti-gravity Exosuit That Reduces Hip Extensor Activity in Sitting Transfers. Front Neurorobot. 2017 Oct 27;11:57. doi: 10.3389/fnbot.2017.00057. eCollection 2017.
PubMed 29163120Ummels D, Beekman E, Theunissen K, Braun S, Beurskens AJ. Counting Steps in Activities of Daily Living in People With a Chronic Disease Using Nine Commercially Available Fitness Trackers: Cross-Sectional Validity Study. JMIR Mhealth Uhealth. 2018 Apr 2;6(4):e70. doi: 10.2196/mhealth.8524.
PubMed 29610110
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Myosuit for Increasing Daily Life Gait Performance in the Home and Community Setting and Gait Capacity in People With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05605912
- Acronym / sponsor ID
- 1033
- Conditions
- Incomplete Spinal Cord Injury
- Keywords
- Myosuit, Exosuit, Rehabilitation, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 21 Aug 2025 (actual)
- First posted
- 4 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myosuit intervention | Experimental | Device: MyosuitParticipants 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. |
| Control | Active comparator | Other: Control, Device: MyosuitParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- People with a stable chronic iSCI (>6 months after injury).
- Having an injury level of C or D on the American Spinal Injury Association Impairment Scale.
- Age ≥ 18 years.
- Need to have sufficient hand function and standing balance to don and doff the Myosuit or they need a caregiver who is available to help the participant to use the Myosuit at home.
- Having reduced gait capacity due to reduced knee and/or hip strength (MRC=<4).
Key exclusion criteria (11 listed)
- Have another (neurological) disease which can influence motor performance.
- Have wounds which can be worsened by wearing the Myosuit will be excluded.
- Taller than 195 and smaller than 150 cm.
- Body weight of more than 110 kg or less than 45 kg.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlParticipants 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. | Other | Control |
| MyosuitAlso: MyoswissParticipants 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. | Device | Control, Myosuit intervention |
Primary outcome
Change from baseline daily life gait performance to the home period as assessed by walking time per day (minutes)
Time frame: Baseline: Week 1 (T0), During the 6-week home period: average over week 6, 8, 11 (T2, T3, T4)
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)
Change in preferred walking speed between with and without Myosuit as assessed by the 10 meter walk test (m/s)
Time frame: After the clinical training program: Week 5 (Myosuit intervention, T1) or week 16 (Control, T6)
Measure for gait capacity. (experimental design)
21 secondary outcomes
Daily life gait performance as assessed by gait quality
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)
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)
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)
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)
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)
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)
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)
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
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)
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)
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)
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Step length as assessed by walking on the GRAIL
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Step time as assessed by walking on the GRAIL
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Ankle range of motion as assessed by walking on the GRAIL
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Maximum ankle plantar flexion as assessed by walking on the GRAIL
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Knee range of motion as assessed by walking on the GRAIL
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Maximum knee extension as assessed by walking on the GRAIL
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Hip range of motion as assessed by walking on the GRAIL
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Maximum hip extension as assessed by walking on the GRAIL
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
Time frame: After the clinical training program: Week 5 and 16 (T1, T6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 25254140Balasubramanian CK, Clark DJ, Fox EJ. Walking adaptability after a stroke and its assessment in clinical settings. Stroke Res Treat. 2014;2014:591013. doi: 10.1155/2014/591013. Epub 2014 Aug 28.
- Background: PubMed 26364282DiPiro ND, Holthaus KD, Morgan PJ, Embry AE, Perry LA, Bowden MG, Gregory CM. Lower Extremity Strength Is Correlated with Walking Function After Incomplete SCI. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):133-9. doi: 10.1310/sci2102-133. Epub 2015 Apr 12.
- Background: PubMed 29976900Fanchamps MHJ, Horemans HLD, Ribbers GM, Stam HJ, Bussmann JBJ. The Accuracy of the Detection of Body Postures and Movements Using a Physical Activity Monitor in People after a Stroke. Sensors (Basel). 2018 Jul 5;18(7):2167. doi: 10.3390/s18072167.
- Background: PubMed 31374751Haufe FL, Kober AM, Schmidt K, Sancho-Puchades A, Duarte JE, Wolf P, Riener R. User-driven walking assistance: first experimental results using the MyoSuit. IEEE Int Conf Rehabil Robot. 2019 Jun;2019:944-949. doi: 10.1109/ICORR.2019.8779375.
- Background: PubMed 33032627Haufe FL, Schmidt K, Duarte JE, Wolf P, Riener R, Xiloyannis M. Activity-based training with the Myosuit: a safety and feasibility study across diverse gait disorders. J Neuroeng Rehabil. 2020 Oct 8;17(1):135. doi: 10.1186/s12984-020-00765-4.
- Background: PubMed 32206335Horemans H, Kooijmans H, van den Berg-Emons R, Bussmann H. The Activ8 activity monitor: Validation of posture and movement classification. J Rehabil Assist Technol Eng. 2020 Mar 16;7:2055668319890535. doi: 10.1177/2055668319890535. eCollection 2020 Jan-Dec.
- Background: PubMed 22234663Ishikawa S, Stevens SL, Kang M, Morgan DW. Reliability of daily step activity monitoring in adults with incomplete spinal cord injury. J Rehabil Res Dev. 2011;48(10):1187-94. doi: 10.1682/jrrd.2010.09.0190.
- Background: PubMed 35320878Just IA, Fries D, Loewe S, Falk V, Cesarovic N, Edelmann F, Feuerstein A, Haufe FL, Xiloyannis M, Riener R, Schoenrath F. Movement therapy in advanced heart failure assisted by a lightweight wearable robot: a feasibility pilot study. ESC Heart Fail. 2022 Jun;9(3):1643-1650. doi: 10.1002/ehf2.13903. Epub 2022 Mar 23.
- Background: PubMed 30649497Lankhorst K, van den Berg-Emons RJ, Bussmann JBJ, Horemans HLD, de Groot JF. A Novel Tool for Quantifying and Promoting Physical Activity in Youths With Typical Development and Youths Who Are Ambulatory and Have Motor Disability. Phys Ther. 2019 Mar 1;99(3):354-363. doi: 10.1093/ptj/pzy152.
- Background: PubMed 33191498Maetzler W, Rochester L, Bhidayasiri R, Espay AJ, Sanchez-Ferro A, van Uem JMT. Modernizing Daily Function Assessment in Parkinson's Disease Using Capacity, Perception, and Performance Measures. Mov Disord. 2021 Jan;36(1):76-82. doi: 10.1002/mds.28377. Epub 2020 Nov 15.
- Background: PubMed 33182658Muthukrishnan N, Abbas JJ, Krishnamurthi N. A Wearable Sensor System to Measure Step-Based Gait Parameters for Parkinson's Disease Rehabilitation. Sensors (Basel). 2020 Nov 10;20(22):6417. doi: 10.3390/s20226417.
- Background: PubMed 32816676Mohamed Refai MI, van Beijnum BF, Buurke JH, Veltink PH. Portable Gait Lab: Tracking Relative Distances of Feet and CoM Using Three IMUs. IEEE Trans Neural Syst Rehabil Eng. 2020 Oct;28(10):2255-2264. doi: 10.1109/TNSRE.2020.3018158. Epub 2020 Aug 20.
- Link to the research project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart van den Bemt principal investigator
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myosuit in people with Incomplete Spinal Cord Injury, run by Sint Maartenskliniek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline daily life gait performance to the home period as assessed by walking time per day (minutes) (time frame: Baseline: Week 1 (T0), During the 6-week home period: average over week 6, 8, 11 (T2, T3, T4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05605912, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.