Effect of Different Support Systems on Gait

May 13, 2025 updated by: Noel Keijsers, Sint Maartenskliniek

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Netherlands
      • Ubbergen, Netherlands
        • Sint Maartenskliniek

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
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
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
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
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
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
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
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
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
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
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
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
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
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
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
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.
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
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
At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sex (man/woman)
Time Frame: Subject enrollment
Descriptive outcome measure
Subject enrollment
Age (years)
Time Frame: Subject enrollment
Descriptive outcome measure
Subject enrollment
Body Mass Index
Time Frame: Subject enrollment
Descriptive outcome measure. Calculated with weight and height.
Subject enrollment
Time since spinal cord injury (years)
Time Frame: Subject enrollment
Descriptive outcome measure.
Subject enrollment
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).
Subject enrollment
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.
Subject enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sint Maartenskliniek

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bart van den Bemt, Sint Maartenskliniek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Incomplete Spinal Cord Injury

Clinical Trials on Regular walking

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings