Effect of Different Support Systems on Gait

Incomplete Spinal Cord Injury Clinical Trial

Official title:

Effect of a Body Weight Support System and a Soft Exosuit on Gait in People With Incomplete Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06214546
• Other study ID #: 1124
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2023
• Source: Sint Maartenskliniek
• Contact: Lara Visch
• Phone: 024-3272701
• Email: la.visch[@]maartenskliniek.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Incomplete Spinal Cord Injury
• Spinal Cord Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Netherlands	Sint Maartenskliniek	Ubbergen

Sponsors (1)

Lead Sponsor	Collaborator
Sint Maartenskliniek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex (man/woman)	Descriptive outcome measure	Subject enrollment
Other	Age (years)	Descriptive outcome measure	Subject enrollment
Other	Body Mass Index	Descriptive outcome measure. Calculated with weight and height.	Subject enrollment
Other	Time since spinal cord injury (years)	Descriptive outcome measure.	Subject enrollment
Other	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
Other	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
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)