Myosuit in Incomplete Spinal Cord Injury

NCT05605912 | Completed DMC

• 2 other identifiers: 1033NL80641.091.22
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incomplete Spinal Cord Injury

Keywords

Myosuit; Exosuit; Rehabilitation; Walking

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (21)

• Daily life gait performance as assessed by gait quality

  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)

  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)

  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)

  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)

  Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)

Other Outcomes (11)

• Sex (man/woman)

  Baseline: Week 1 (T0)

• Age (years)

  Baseline: Week 1 (T0)

• Height (cm)

  Baseline: Week 1 (T0)

Study Arms (2)

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.

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.

Other: Control; Device: Myosuit

Interventions

Control OTHER

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.

Control

Myosuit DEVICE

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

Control; Myosuit intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sint Maartenskliniek: lead

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Netherlands

Location

Related Publications (19)

• 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.

  PMID: 25254140 BACKGROUND

• 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.

  PMID: 26364282 BACKGROUND

• 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.

  PMID: 29976900 BACKGROUND

• 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.

  PMID: 31374751 BACKGROUND

• 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.

  PMID: 33032627 BACKGROUND

• 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.

  PMID: 32206335 BACKGROUND

• 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.

  PMID: 22234663 BACKGROUND

• 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.

  PMID: 35320878 BACKGROUND

• 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.

  PMID: 30649497 BACKGROUND

• 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.

  PMID: 33191498 BACKGROUND

• 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.

  PMID: 33182658 BACKGROUND

• 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.

  PMID: 32816676 BACKGROUND

• 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.

  PMID: 20022997 BACKGROUND

• 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.

  PMID: 29163120 BACKGROUND

• 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.

  PMID: 29610110 BACKGROUND

• 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.

  PMID: 15644078 BACKGROUND

• 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.

  PMID: 30524356 BACKGROUND

• 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.

  PMID: 26645499 BACKGROUND

• Visch L, Groen BE, Geurts ACH, van Nes IJW, Keijsers NLW. Effect of a soft exosuit on daily life gait performance in people with incomplete spinal cord injury: study protocol for a randomized controlled trial. Trials. 2024 Sep 6;25(1):592. doi: 10.1186/s13063-024-08412-2.

  PMID: 39242508 DERIVED

Related Links

• Link to the research project website

Study Officials

• Bart van den Bemt

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof N.L.W Keijsers

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 4, 2022
• Study Start: October 3, 2022
• Primary Completion: August 21, 2025
• Study Completion: August 21, 2025
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)