Myosuit in Incomplete Spinal Cord Injury

Incomplete Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605912
• Other study ID #: 1033
• Secondary ID: NL80641.091.22
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Sint Maartenskliniek
• Contact: Lara Visch
• Phone: 024-3272701
• Email: la.visch[@]maartenskliniek.nl
• Is FDA regulated: No
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.
• 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

Exclusion Criteria:

• 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
• 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.

Related Conditions & MeSH terms

• Incomplete Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Control
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.

Device:
• Myosuit
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.

Locations

Country	Name	City	State
Netherlands	Sint Maartenskliniek	Ubbergen

Sponsors (1)

Lead Sponsor	Collaborator
Sint Maartenskliniek

Country where clinical trial is conducted

Netherlands, 

References & Publications (18)

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DiPiro 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. — View Citation

Fanchamps 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. — View Citation

Haufe 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. — View Citation

Haufe 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. — View Citation

Horemans 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. — View Citation

Ishikawa 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. — View Citation

Just 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. — View Citation

Lankhorst 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. — View Citation

Maetzler 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. — View Citation

Mohamed 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. — View Citation

Muthukrishnan 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. — View Citation

Saraf 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. — View Citation

Schmidt 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. — View Citation

Ummels 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. — View Citation

van der Salm A, Nene AV, Maxwell DJ, Veltink PH, Hermens HJ, IJzerman MJ. Gait impairments in a group of patients with incomplete spinal cord injury and their relevance regarding therapeutic approaches using functional electrical stimulation. Artif Organs. 2005 Jan;29(1):8-14. doi: 10.1111/j.1525-1594.2004.29004.x. — View Citation

van Dijsseldonk RB, de Jong LAF, Groen BE, Vos-van der Hulst M, Geurts ACH, Keijsers NLW. Gait Stability Training in a Virtual Environment Improves Gait and Dynamic Balance Capacity in Incomplete Spinal Cord Injury Patients. Front Neurol. 2018 Nov 20;9:963. doi: 10.3389/fneur.2018.00963. eCollection 2018. — View Citation

van Uem JM, Marinus J, Canning C, van Lummel R, Dodel R, Liepelt-Scarfone I, Berg D, Morris ME, Maetzler W. Health-Related Quality of Life in patients with Parkinson's disease--A systematic review based on the ICF model. Neurosci Biobehav Rev. 2016 Feb;61:26-34. doi: 10.1016/j.neubiorev.2015.11.014. Epub 2015 Dec 2. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex (man/woman)	Descriptive outcome measure.	Baseline: Week 1 (T0)
Other	Age (years)	Descriptive outcome measure.	Baseline: Week 1 (T0)
Other	Height (cm)	Descriptive outcome measure.	Baseline: Week 1 (T0)
Other	Weight (kg)	Descriptive outcome measure.	Baseline: Week 1 (T0)
Other	Body Mass Index	Descriptive outcome measure. Calculated with weight and height.	Baseline: Week 1 (T0)
Other	Time since spinal cord injury (years)	Descriptive outcome measure.	Baseline: Week 1 (T0)
Other	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).	Baseline: Week 1 (T0)
Other	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.	Baseline: Week 1 (T0)
Other	Muscle strength as assessed by Medical Research Council (MRC) scale	Descriptive outcome measure. Range from 0 - 5 with higher scores indicating more strength	Baseline: Week 1 (T0)
Other	Spasticity as assessed by Modified Ashworth Scale (MAS)	Descriptive outcome measure. Range from 0 - 4 with higher scores indicating more spasticity	Baseline: Week 1 (T0)
Other	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	Baseline: Week 1 (T0)
Primary	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)	Baseline: Week 1 (T0), During the 6-week home period: average over week 6, 8, 11 (T2, T3, T4)
Primary	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)	After the clinical training program: Week 5 (Myosuit intervention, T1) or week 16 (Control, T6)
Secondary	Daily life gait performance as assessed by gait quality	Measured by inertial measurement units. (RCT)	Baseline: Week 1 (T0), During the 6-week home period: week 6 and 11 (T2, T4) and week 17 and 22 (T7, T9)
Secondary	Change from baseline preferred walking speed at T5 as assessed by the 10 meter walk test (m/s)	Measure for gait capacity. (RCT)	Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Secondary	Maximum walking speed as assessed by the 10 meter walk test (m/s)	Measure for gait capacity. (RCT)	Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Secondary	Walking speed as assessed by the 6 minutes walk test (m/s)	Measure for gait capacity. (RCT)	Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Secondary	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)	Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Secondary	Usability as assessed by the System Usability Scale (SUS)	The range is between 0 and 100, with a higher score indicating better usability. (RCT)	After the clinical training program: Week 5 and 16 (T1, T6), After the 6-week home period: Week 12 and 23 (T5, T10)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6), After the 6-week home period: Week 12 and 23 (T5, T10)
Secondary	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)	Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Secondary	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)	Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Secondary	Maximum walking speed as assessed by the 10 meter walk test (m/s)	Measure for gait capacity. (experimental design)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	Walking speed as assessed by the 6 minutes walk test (m/s)	Measure for gait capacity. (experimental design)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	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)	After the clinical training program: Week 5 and 16 (T1, T6)
Secondary	Variable error of the precision stepping task as assessed by walking on the GRAIL	Measure for gait adaptability. (experimental design)	After the clinical training program: Week 5 and 16 (T1, T6)

External Links

•   Link to the research project website