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OpenTrials
Completed

NCT Number: NCT06214546

Effect of Different Support Systems on Gait

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint Maartenskliniek

Ubbergen, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People with subacute or chronic iSCI (at least 2 weeks after injury)
  • Have an injury level of C or D on the American Spinal Injury Association Impairment Scale
  • Age ≥ 18 years
  • Walking speed between 0.4 and 0.8 m/s (limited community ambulation) (24)
  • 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 such as, crutches, walking sticks or ankle foot orthoses except knee orthoses or walkers
  • Reduced knee and/or hip strength (MRC=<4).

Exclusion criteria

  • Have another (neurological) disease which can influence motor performance.
  • Have wounds
  • Taller than 195 and smaller than 150 cm
  • Body weight of more than 110 kg or less than 45 kg
  • Pregnancy
  • 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
  • Insufficient mastery of the Dutch language
  • Psychiatric backgrounds
  • Oncological spinal cord injury
  • Stoma
  • Unsuitable for participation according to the rehabilitation physician or researcher

Treatment and study plan

Regular walking

Other

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.

Myosuit

Device

Participants perform 6 overground walking trials (12.5 m) while wearing the Myosuit. ZeroG and Myosuit intervention will be performed in random order.

ZeroG

Device

Participants perform 6 overground walking trials (12.5 m) while walking in the ZeroG. ZeroG and Myosuit intervention will be performed in random order.

Primary outcomes

  1. Dynamic balance during gait: medio-lateral center of mass excursion (cm)

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Medio-lateral center of mass excursion

  2. Gait kinematics: maximum knee extention

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Maximum extension of the knee in sagittal plane

Secondary outcomes

  1. Dynamic balance during gait: step width (cm)

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG.

  2. Gait kinematics: maximum hip extension

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Maximum extension of the hip in sagittal plane

  3. Gait kinematics: range of motion of the knee

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Range of motion of the knee in sagittal plane

  4. Gait kinematics: range of motion of the hip

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Range of motion of the hip in sagittal plane

  5. Gait kinematics: trunk inclination angle

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG. Trunk inclination angle excursion

  6. Walking speed (m/s)

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG

  7. Stride length (m)

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG

  8. Step time (s)

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the Zero.

  9. Double support phase (%)

    Time frame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

    Difference between regular walking, walking with the Myosuit and walking with the ZeroG

Other outcomes

  1. Sex (man/woman)

    Time frame: Subject enrollment

    Descriptive outcome measure

  2. Age (years)

    Time frame: Subject enrollment

    Descriptive outcome measure

  3. Body Mass Index

    Time frame: Subject enrollment

    Descriptive outcome measure. Calculated with weight and height.

  4. Time since spinal cord injury (years)

    Time frame: Subject enrollment

    Descriptive outcome measure.

  5. Spinal cord injury classification defined by the American Spinal Injury Association (ASIA) impairment scale (C or D)

    Time frame: Subject enrollment

    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).

  6. Level of spinal cord injury

    Time frame: Subject enrollment

    Descriptive outcome measure. There are four sections that impact the level of spinal cord injury: cervical, thoracic, lumbar and sacral.

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Registry information

Official study title

Effect of a Body Weight Support System and a Soft Exosuit on Gait in People With Incomplete Spinal Cord Injury

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2024
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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