An interventional study of Regular walking and Myosuit in Incomplete Spinal Cord Injury, sponsored by Sint Maartenskliniek. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Sint Maartenskliniek · Not applicable, Interventional, and Basic science
Body weight support systems are commonly used for gait training. A new breed of devices for gait training are soft exosuits. To optimize rehabilitation outcomes, it is important to gain deeper insight in the effect of these support systems on gait. The aim of this study is to investigate the effect of a body weight support system and soft exosuit on dynamic balance and knee and hip kinematics during gait in people with incomplete spinal cord injury.
Rationale: People with incomplete spinal cord injury (iSCI) often experience gait impairments. Body weight support (BWS) systems are commonly used for gait training. Overground BWS systems could have 2 or 3 degrees of freedom (DoF). A decrease in DoF will reduce the demand's on people's balance capacity during walking. A new breed of devices for gait training are soft exosuits. They could deliver support around the knee and the hip joint, which are the main contributors for bodyweight support. Although a BWS system and a soft exosuit provide both support against gravity these systems differ in the approach of delivering this support. To optimize rehabilitation outcomes, it is important to gain deeper insight in the effect of these support systems on gait. In this study a 2-DoF BWS system, the ZeroG, and a soft exosuit, the Myosuit, will be studied.
Objective: Investigate the effect of a BWS system and soft exosuit on dynamic balance and knee and hip kinematics during gait in people with incomplete spinal cord injury.
Study design: Experimental design.
Study population: Fourteen people with subacute or chronic iSCI (at least 2 weeks after injury) will be included. People with iSCI will be included when having an injury level of C or D on the American Spinal Injury Association Impairment Scale.
Intervention: Participants will visit the Sint Maartenskliniek once and perform overground walking trials in a laboratory setting: regular walking, walking with the ZeroG (BWS system) and walking with the Myosuit (soft exosuit). Each condition consists of 6 walking trials over a distance of 12.5 m.
Main study parameters/endpoints: The main study parameter for dynamic balance during gait will be medio-lateral center of mass excursion. The main study parameter for gait kinematics will be maximum extension of the knee in sagittal plane.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 15 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Sint Maartenskliniek is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants perform 6 overground walking trials (12.5 m) without support system. Participants perform all measurements (regular walking, Myosuit, ZeroG) on one single measurement day.
Participants perform 6 overground walking trials (12.5 m) while wearing the Myosuit. ZeroG and Myosuit intervention will be performed in random order.
Participants perform 6 overground walking trials (12.5 m) while walking in the ZeroG. ZeroG and Myosuit intervention will be performed in random order.
Dynamic balance during gait: medio-lateral center of mass excursion (cm)
Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Medio-lateral center of mass excursion
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Gait kinematics: maximum knee extention
Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Maximum extension of the knee in sagittal plane
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Dynamic balance during gait: step width (cm)
Difference between regular walking, walking with the Myosuit and walking with the ZeroG.
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Gait kinematics: maximum hip extension
Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Maximum extension of the hip in sagittal plane
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Gait kinematics: range of motion of the knee
Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Range of motion of the knee in sagittal plane
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Gait kinematics: range of motion of the hip
Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Range of motion of the hip in sagittal plane
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Gait kinematics: trunk inclination angle
Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Trunk inclination angle excursion
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Walking speed (m/s)
Difference between regular walking, walking with the Myosuit and walking with the ZeroG
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Stride length (m)
Difference between regular walking, walking with the Myosuit and walking with the ZeroG
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Step time (s)
Difference between regular walking, walking with the Myosuit and walking with the Zero.
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Double support phase (%)
Difference between regular walking, walking with the Myosuit and walking with the ZeroG
Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Sex (man/woman)
Descriptive outcome measure
Time frame: Subject enrollment
Age (years)
Descriptive outcome measure
Time frame: Subject enrollment
Body Mass Index
Descriptive outcome measure. Calculated with weight and height.
Time frame: Subject enrollment
Time since spinal cord injury (years)
Descriptive outcome measure.
Time frame: Subject enrollment
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).
Time frame: Subject enrollment
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.
Time frame: Subject enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sint Maartenskliniek