Spinal Cord Injuries
Conditions
Keywords
Spinal Cord Injury, Robot-Assisted Gait Training, Functional Mobility, Guidance Force
Brief summary
This study compares two robotic-assisted gait training systems, Lokomat® and RoboGait®, used under different guidance force (GF) settings, in people with motor-incomplete spinal cord injury (iSCI). Nineteen adults, aged 18 years or older, with injury at T3 level or below and classified as AIS C or D within two years of injury, participated. They were assigned to one of three groups based on the average GF used during training: Lok90- (GF \< 90% with Lokomat®), Lok90+ (GF ≥ 90% with Lokomat®), and RG (GF ≥ 90% with RoboGait®). All participants completed 10 treadmill-based gait training sessions over 4 weeks, in addition to standard physiotherapy including stretching, strengthening, balance, and walking exercises. Walking ability, mobility, muscle strength, balance, independence in daily activities, and quality of life were assessed before and after the program. The study aimed to see whether the type of robot and GF setting affected recovery. Results showed modest improvements in some outcomes, with changes depending on the group and outcome measured. Findings suggest that adjusting GF settings may help tailor robotic gait training to individual needs.
Detailed description
This pilot study investigated the effects of two robotic-assisted gait training systems, Lokomat® V6 (Hocoma AG, Switzerland) and RoboGait® (BAMA Teknoloji, Türkiye), applied under different guidance force (GF) settings, on walking ability, functional mobility, and health-related quality of life in individuals with motor-incomplete spinal cord injury (iSCI). Eligible participants were aged 18 years or older, with injury at T3 level or below, AIS C or D classification, and injury duration of 2 years or less. Exclusion criteria included severe spasticity (Modified Ashworth Scale ≥ 3), joint disorders, implanted electronic devices, orthostatic hypotension, cardiac problems, or conditions preventing secure positioning in the robotic systems. Participants were assigned to three groups according to their average GF during training: Lok90- (GF \< 90% with Lokomat®), Lok90+ (GF ≥ 90% with Lokomat®), and RG (GF ≥ 90% with RoboGait®). All participants completed 10 treadmill-based gait training sessions over 4 weeks, with three sessions per week. Walking speed and angular parameters were individually adjusted to enhance comfort, reduce fatigue, and encourage active participation. Alongside robotic gait training, all participants received conventional physiotherapy that included stretching, strengthening, balance, walking, and mobility exercises. The primary outcome was walking status, measured using the Walking Index for Spinal Cord Injury II (WISCI II). Secondary outcomes included, functional mobility (Timed Up and Go Test, TUG), lower extremity muscle strength (LEMS), balance (Berg Balance Scale, BBS), functional independence (Spinal Cord Independence Measure III, SCIM III), and health-related quality of life (WHOQOL-BREF-TR). The study aimed to determine whether the type of robotic system and GF settings influence functional outcomes in iSCI rehabilitation.
Interventions
DEVICELokomat® V6 (GF < 90%)
Robotic-assisted gait training using the Lokomat® V6 system (Hocoma AG, Switzerland) with an average guidance force of less than 90%. Training was delivered three times per week for 4 weeks, totaling 10 sessions. In addition to robotic gait training, participants received conventional physiotherapy, including stretching, strengthening, balance, walking, and mobility exercises.
DEVICELokomat® V6 (GF ≥ 90%)
Robotic-assisted gait training using the Lokomat® V6 system (Hocoma AG, Switzerland) with an average guidance force of 90% or higher. Training was delivered three times per week for 4 weeks, totaling 10 sessions. In addition to robotic gait training, participants received conventional physiotherapy, including stretching, strengthening, balance, walking, and mobility exercises.
DEVICERoboGait®
Robotic-assisted gait training using the RoboGait® system (BAMA Teknoloji, Türkiye) with an average guidance force of 90% or higher. Training was delivered three times per week for 4 weeks, totaling 10 sessions. In addition to robotic gait training, participants received conventional physiotherapy, including stretching, strengthening, balance, walking, and mobility exercises.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Diagnosis of spinal cord injury (SCI) at T3 level or below. * Injury duration of no more than 2 years. * Functional classification of C or D based on the American Spinal Injury Association (ASIA) Impairment Scale. * ICD-10 diagnosis codes between S24.73-S24.77 or S34.70
Exclusion criteria
* Participation in another study. * Joint disorders affecting mobility. * Implanted electronic devices. * Orthostatic hypotension. * Severe spasticity in the lower extremities (Modified Ashworth Scale score ≥ 3). * Cardiac problems or conditions impairing stabilization in the robotic systems. * Presence of a colostomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Index in Spinal Cord Injury II | 24 months | Walking Index in Spinal Cord Injury II for walking independence level assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test | 24 months | Timed Up and Go Test overground walking assessment |
| Berg Balance Scale | 24 months | Berg Balance Scale for balance assessment |
| ASIA Lower Extremity Muscle Score | 24 months | Assessment of lower extremity muscle strength using the American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS) |
| Spinal Cord Independence Measure (SCIM III) | 24 months | Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment |
| World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) | 24 months | World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment |
Countries
Turkey (Türkiye)
Outcome results
None listed