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Incomplete Spinal Cord InjuryNCT06214546

Effect of Different Support Systems on Gait

A study testing Regular walking, Myosuit and ZeroG in people with Incomplete Spinal Cord Injury, run by Sint Maartenskliniek at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Incomplete Spinal Cord Injury
What is being tested?
Regular walking, Myosuit and ZeroG
Type of treatment
Medical device
How many people
15 participants
Where
1 siteNetherlands
Study dates
25 Oct 2023to 28 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Sint Maartenskliniek

    Ubbergen

Other trials in Netherlands

About this study

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

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.

Read the detailed description

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.

Being tested
Regular walking, Myosuit, ZeroG
Keywords
ZeroG, Myosuit, Gait, Rehabilitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regular walkingOther

    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.

  • MyosuitDevice

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

  • ZeroGDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

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

Secondary outcomes (9)

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

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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. Gait kinematics: trunk inclination angle

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

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

  6. Walking speed (m/s)

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

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

  7. Stride length (m)

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

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

  8. Step time (s)

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

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

  9. Double support phase (%)

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start25 Oct 2023
  3. Primary completion28 Aug 2024
  4. Study completion28 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06214546
Sponsor's protocol ID
1124
Status last verified
Dec 2024
First submitted
23 Nov 2023
Last updated
16 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Regular walking, Myosuit and ZeroG in people with Incomplete Spinal Cord Injury, run by Sint Maartenskliniek at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06214546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.

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