Effect of Different Support Systems on Gait

NCT06214546 | Completed

• 1 other identifier: 1124
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Incomplete Spinal Cord Injury

Keywords

ZeroG; Myosuit; Gait; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Dynamic balance during gait: step width (cm)

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

• Gait kinematics: maximum hip extension

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

• Gait kinematics: range of motion of the knee

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

• Gait kinematics: range of motion of the hip

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

• Gait kinematics: trunk inclination angle

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

Other Outcomes (6)

• Sex (man/woman)

  Subject enrollment

• Age (years)

  Subject enrollment

• Body Mass Index

  Subject enrollment

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sint Maartenskliniek: lead

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Netherlands

Location

Study Officials

• Bart van den Bemt

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof N.L.W Keijsers

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: January 19, 2024
• Study Start: October 25, 2023
• Primary Completion: August 28, 2024
• Study Completion: August 28, 2024
• Last Updated: May 16, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)