Lokomat® vs RoboGait® Under Different Guidance Force Settings in Motor-Incomplete SCI

NCT ID: NCT07137780

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2024-11-23

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lok90- (GF < 90% with Lokomat®)

Participants in this arm received robotic-assisted gait training using the Lokomat® V6 system (Hocoma AG, Switzerland) with an average guidance force (GF) of less than 90%. Training was conducted three times per week for 4 weeks, totaling 10 sessions. In addition to robotic gait training, participants also received conventional physiotherapy, including stretching, strengthening, balance, walking, and mobility exercises.

Group Type: EXPERIMENTAL

Lokomat® V6 (GF < 90%)

Intervention Type: DEVICE

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.

Lok90+ (GF ≥ 90% with Lokomat®)

Participants in this arm received robotic-assisted gait training using the Lokomat® V6 system (Hocoma AG, Switzerland) with an average guidance force (GF) of 90% or higher. Training was conducted three times per week for 4 weeks, totaling 10 sessions. In addition to robotic gait training, participants also received conventional physiotherapy, including stretching, strengthening, balance, walking, and mobility exercises.

Group Type: EXPERIMENTAL

Lokomat® V6 (GF ≥ 90%)

Intervention Type: DEVICE

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.

RG (RoboGait®)

Participants in this arm received robotic-assisted gait training using the RoboGait® system (BAMA Teknoloji, Türkiye) with an average guidance force (GF) of 90% or higher. Training was conducted three times per week for 4 weeks, totaling 10 sessions. In addition to robotic gait training, participants also received conventional physiotherapy, including stretching, strengthening, balance, walking, and mobility exercises.

Group Type: EXPERIMENTAL

RoboGait®

Intervention Type: DEVICE

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.

Interventions

Lokomat® 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.

Intervention Type: DEVICE

Lokomat® 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.

Intervention Type: DEVICE

RoboGait®

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ankara City Hospital

Çankaya, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AnkaraCHBilkent-PMR-MSS-03

Identifier Type: -

Identifier Source: org_study_id