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

NCT07137780 | Completed

• 1 other identifier: AnkaraCHBilkent-PMR-MSS-03
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; Robot-Assisted Gait Training; Functional Mobility; Guidance Force

Outcome Measures

Primary Outcomes (1)

• Walking Index in Spinal Cord Injury II

  Walking Index in Spinal Cord Injury II for walking independence level assessment

  24 months

Secondary Outcomes (5)

• Timed Up and Go Test

  24 months

• Berg Balance Scale

  24 months

• ASIA Lower Extremity Muscle Score

  24 months

• Spinal Cord Independence Measure (SCIM III)

  24 months

• World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)

  24 months

Study Arms (3)

Lok90- (GF < 90% with Lokomat®)

EXPERIMENTAL

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.

Device: Lokomat® V6 (GF < 90%)

Lok90+ (GF ≥ 90% with Lokomat®)

EXPERIMENTAL

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.

Device: Lokomat® V6 (GF ≥ 90%)

RG (RoboGait®)

EXPERIMENTAL

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.

Device: RoboGait®

Interventions

Lokomat® V6 (GF ≥ 90%) 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.

Lok90+ (GF ≥ 90% with Lokomat®)

RoboGait® 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.

RG (RoboGait®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Çankaya, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: November 23, 2022
• Primary Completion: November 23, 2024
• Study Completion: November 23, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

TU (1)