Effect of Different Support Systems on Gait

NCT ID: NCT06214546

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2024-08-28

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.

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.

Conditions

Incomplete Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

Regular walking

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.

Intervention Type: OTHER

Myosuit

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

Intervention Type: DEVICE

ZeroG

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sint Maartenskliniek

OTHER

Sponsor Role: lead

Responsible Party

Noel Keijsers

Prof N.L.W Keijsers

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bart van den Bemt

Role: PRINCIPAL_INVESTIGATOR

Sint Maartenskliniek

Locations

Sint Maartenskliniek

Ubbergen, , Netherlands

Countries

Netherlands

Other Identifiers

1124

Identifier Type: -

Identifier Source: org_study_id