NCT06214546

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Sint Maartenskliniek · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2023-10-25
• Primary completion: 2024-08-28
• Completion: 2024-08-28
• First posted: 2024-01-19
• Last updated: 2025-05-16

Locations

1 site across 1 country: Netherlands