Clinical trial NCT06214546: Effect of Different Support Systems on Gait
Official title: Effect of a Body Weight Support System and a Soft Exosuit on Gait in People With Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Keywords: ZeroG
Myosuit
Gait
Rehabilitation
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Dynamic balance during gait: medio-lateral center of mass excursion (cm)
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
measure: Gait kinematics: maximum knee extention
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Secondary outcomes:
measure: Dynamic balance during gait: step width (cm)
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
measure: Gait kinematics: maximum hip extension
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
measure: Gait kinematics: range of motion of the knee
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
measure: Gait kinematics: range of motion of the hip
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
measure: Gait kinematics: trunk inclination angle
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
measure: Walking speed (m/s)
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
measure: Stride length (m)
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
measure: Step time (s)
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
measure: Double support phase (%)
timeFrame: At baseline (during regular walking, during walking with the Myosuit, during walking with the ZeroG)
Other outcomes:
measure: Sex (man/woman)
timeFrame: Subject enrollment
measure: Age (years)
timeFrame: Subject enrollment
measure: Body Mass Index
timeFrame: Subject enrollment
measure: Time since spinal cord injury (years)
timeFrame: Subject enrollment
measure: Spinal cord injury classification defined by the American Spinal Injury Association (ASIA) impairment scale (C or D)
timeFrame: Subject enrollment
measure: Level of spinal cord injury
timeFrame: Subject enrollment
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
affiliation: Sint Maartenskliniek
name: Bart van den Bemt
role: PRINCIPAL_INVESTIGATOR
References: