Effect of Different Support Systems on Gait

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: Completed
• Conditions: Incomplete Spinal Cord Injury
• Intervention / Treatment: Other: Regular walking; Device: Myosuit; Device: ZeroG

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: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Ubbergen, Netherlands
    • Sint Maartenskliniek

Participation Criteria

Eligibility Criteria

• 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

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

Outcome Measure	Measure Description	Time Frame
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	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	At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dynamic balance during gait: step width (cm)	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	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	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	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	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)	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)	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)	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 (%)	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

Outcome Measure	Measure Description	Time Frame
Sex (man/woman)	Descriptive outcome measure	Subject enrollment
Age (years)	Descriptive outcome measure	Subject enrollment
Body Mass Index	Descriptive outcome measure. Calculated with weight and height.	Subject enrollment
Time since spinal cord injury (years)	Descriptive outcome measure.	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).	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.	Subject enrollment

Collaborators and Investigators

• Sponsor: Sint Maartenskliniek
• Investigators: Principal Investigator: Bart van den Bemt, Sint Maartenskliniek

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Actual): August 28, 2024
• Study Completion (Actual): August 28, 2024

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Rehabilitation; Gait; Myosuit; ZeroG
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID 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