Study Results
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Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2022-10-03
2025-08-21
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Control
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.
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.
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.
Myosuit intervention
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Sint Maartenskliniek
OTHER
Responsible Party
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Noel Keijsers
Prof N.L.W Keijsers
Principal Investigators
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Bart van den Bemt
Role: PRINCIPAL_INVESTIGATOR
Sint Maartenskliniek
Locations
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Sint Maartenskliniek
Ubbergen, , Netherlands
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Link to the research project website
Other Identifiers
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NL80641.091.22
Identifier Type: OTHER
Identifier Source: secondary_id
1033
Identifier Type: -
Identifier Source: org_study_id
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