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Myosuit in Incomplete Spinal Cord Injury

Primary Purpose

Incomplete Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Control
Myosuit
Sponsored by
Sint Maartenskliniek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incomplete Spinal Cord Injury focused on measuring Myosuit, Exosuit, Rehabilitation, Walking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sint MaartenskliniekRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myosuit intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Daily life gait performance as assessed by gait quality
Measured by inertial measurement units. (RCT)
Change from baseline preferred walking speed at T5 as assessed by the 10 meter walk test (m/s)
Measure for gait capacity. (RCT)
Maximum walking speed as assessed by the 10 meter walk test (m/s)
Measure for gait capacity. (RCT)
Walking speed as assessed by the 6 minutes walk test (m/s)
Measure for gait capacity. (RCT)
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)
Usability as assessed by the System Usability Scale (SUS)
The range is between 0 and 100, with a higher score indicating better usability. (RCT)
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)
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)
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)
Maximum walking speed as assessed by the 10 meter walk test (m/s)
Measure for gait capacity. (experimental design)
Walking speed as assessed by the 6 minutes walk test (m/s)
Measure for gait capacity. (experimental design)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Variable error of the precision stepping task as assessed by walking on the GRAIL
Measure for gait adaptability. (experimental design)

Full Information

First Posted
October 19, 2022
Last Updated
November 2, 2022
Sponsor
Sint Maartenskliniek
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1. Study Identification

Unique Protocol Identification Number
NCT05605912
Brief Title
Myosuit in Incomplete Spinal Cord Injury
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sint Maartenskliniek

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incomplete Spinal Cord Injury
Keywords
Myosuit, Exosuit, Rehabilitation, Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myosuit intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Myosuit
Other Intervention Name(s)
Myoswiss
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline daily life gait performance to the home period as assessed by walking time per day (minutes)
Description
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)
Title
Change in preferred walking speed between with and without Myosuit as assessed by the 10 meter walk test (m/s)
Description
Measure for gait capacity. (experimental design)
Time Frame
After the clinical training program: Week 5 (Myosuit intervention, T1) or week 16 (Control, T6)
Secondary Outcome Measure Information:
Title
Daily life gait performance as assessed by gait quality
Description
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)
Title
Change from baseline preferred walking speed at T5 as assessed by the 10 meter walk test (m/s)
Description
Measure for gait capacity. (RCT)
Time Frame
Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Title
Maximum walking speed as assessed by the 10 meter walk test (m/s)
Description
Measure for gait capacity. (RCT)
Time Frame
Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Title
Walking speed as assessed by the 6 minutes walk test (m/s)
Description
Measure for gait capacity. (RCT)
Time Frame
Baseline: Week 1 (T0), After the 6-week home period: Week 12 and 23 (T5, T10)
Title
Functional ambulation as assessed by the spinal cord injury functional ambulation profile (SCI-FAP)
Description
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)
Title
Usability as assessed by the System Usability Scale (SUS)
Description
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)
Title
Usability as assessed by the Dutch version of the quebec user evaluation of satisfaction with assistive technology (D-QUEST)
Description
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)
Title
Quality-adjusted-life years gain assessed by EuroQol five-dimension scale questionnaire (EQ5D-5L)
Description
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)
Title
General and Disease Specific Self-efficacy Scale
Description
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)
Title
Maximum walking speed as assessed by the 10 meter walk test (m/s)
Description
Measure for gait capacity. (experimental design)
Time Frame
After the clinical training program: Week 5 and 16 (T1, T6)
Title
Walking speed as assessed by the 6 minutes walk test (m/s)
Description
Measure for gait capacity. (experimental design)
Time Frame
After the clinical training program: Week 5 and 16 (T1, T6)
Title
Preferred walking speed as assessed by walking on the GRAIL (m/s)
Description
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)
Title
Step length as assessed by walking on the GRAIL
Description
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)
Title
Step time as assessed by walking on the GRAIL
Description
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)
Title
Ankle range of motion as assessed by walking on the GRAIL
Description
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)
Title
Maximum ankle plantar flexion as assessed by walking on the GRAIL
Description
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)
Title
Knee range of motion as assessed by walking on the GRAIL
Description
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)
Title
Maximum knee extension as assessed by walking on the GRAIL
Description
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)
Title
Hip range of motion as assessed by walking on the GRAIL
Description
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)
Title
Maximum hip extension as assessed by walking on the GRAIL
Description
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)
Title
Variable error of the precision stepping task as assessed by walking on the GRAIL
Description
Measure for gait adaptability. (experimental design)
Time Frame
After the clinical training program: Week 5 and 16 (T1, T6)
Other Pre-specified Outcome Measures:
Title
Sex (man/woman)
Description
Descriptive outcome measure.
Time Frame
Baseline: Week 1 (T0)
Title
Age (years)
Description
Descriptive outcome measure.
Time Frame
Baseline: Week 1 (T0)
Title
Height (cm)
Description
Descriptive outcome measure.
Time Frame
Baseline: Week 1 (T0)
Title
Weight (kg)
Description
Descriptive outcome measure.
Time Frame
Baseline: Week 1 (T0)
Title
Body Mass Index
Description
Descriptive outcome measure. Calculated with weight and height.
Time Frame
Baseline: Week 1 (T0)
Title
Time since spinal cord injury (years)
Description
Descriptive outcome measure.
Time Frame
Baseline: Week 1 (T0)
Title
Spinal cord injury classification defined by the American Spinal Injury Association (ASIA) impairment scale (C or D)
Description
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)
Title
Level of spinal cord injury
Description
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)
Title
Muscle strength as assessed by Medical Research Council (MRC) scale
Description
Descriptive outcome measure. Range from 0 - 5 with higher scores indicating more strength
Time Frame
Baseline: Week 1 (T0)
Title
Spasticity as assessed by Modified Ashworth Scale (MAS)
Description
Descriptive outcome measure. Range from 0 - 4 with higher scores indicating more spasticity
Time Frame
Baseline: Week 1 (T0)
Title
Sensory function as assessed by the American Spinal Cord Injury Association (ASIA) Impairment Scale
Description
Descriptive outcome measure. Range from 0 - 2 with lower scores indicating more impaired sensory function
Time Frame
Baseline: Week 1 (T0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lara Visch
Phone
024-3272701
Email
la.visch@maartenskliniek.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Noël Keijsers
Phone
024-3528139
Email
n.keijsers@maartenskliniek.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart van den Bemt
Organizational Affiliation
Sint Maartenskliniek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint Maartenskliniek
City
Ubbergen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara Visch

12. IPD Sharing Statement

Plan to Share IPD
No
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PubMed Identifier
30524356
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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.
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Links:
URL
https://www.maartenskliniek.nl/research-innovation-en/research-innovation-projects/efficacy-of-the-myosuit
Description
Link to the research project website

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Myosuit in Incomplete Spinal Cord Injury

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