Spinal Cord InjuriesNCT07137780
Lokomat® vs RoboGait® Under Different Guidance Force Settings in Motor-Incomplete SCI
A study testing Lokomat® V6 (GF < 90%), Lokomat® V6 (GF ≥ 90%) and RoboGait® in people with Spinal Cord Injuries, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Lokomat® V6 (GF < 90%), Lokomat® V6 (GF ≥ 90%) and RoboGait®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Nov 2022to 23 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lokomat® Versus RoboGait®: Comparative Effects on Walking, Mobility, and Quality of Life Under Different Guidance Force Settings in Motor-Incomplete Spinal Cord Injury
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.
Read the 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
- Being tested
- Lokomat® V6 (GF < 90%), Lokomat® V6 (GF ≥ 90%), RoboGait®
- Keywords
- Spinal Cord Injury, Robot-Assisted Gait Training, Functional Mobility, Guidance Force
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lokomat® V6 (GF < 90%)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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: RoboGait® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Index in Spinal Cord Injury II
Walking Index in Spinal Cord Injury II for walking independence level assessment
Measured: 24 months
Secondary outcomes (5)
Timed Up and Go Test
Timed Up and Go Test overground walking assessment
Measured: 24 months
Berg Balance Scale
Berg Balance Scale for balance assessment
Measured: 24 months
ASIA Lower Extremity Muscle Score
Assessment of lower extremity muscle strength using the American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
Measured: 24 months
Spinal Cord Independence Measure (SCIM III)
Spinal Cord Independence Measure (SCIM III) for activity of daily living assessment
Measured: 24 months
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF) for quality of life assessment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start23 Nov 2022
- Primary completion23 Nov 2024
- Study completion23 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137780
- Sponsor's protocol ID
- AnkaraCHBilkent-PMR-MSS-03
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lokomat® Versus RoboGait®: Comparative Effects on Walking, Mobility, and Quality of Life Under Different Guidance Force Settings in Motor-Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07137780
- Acronym / sponsor ID
- AnkaraCHBilkent-PMR-MSS-03
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, Robot-Assisted Gait Training, Functional Mobility, Guidance Force
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 23 Nov 2024 (actual)
- Study completion
- 23 Nov 2024 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lok90- (GF < 90% with Lokomat®) | Experimental | Device: Lokomat® V6 (GF < 90%)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. |
| Lok90+ (GF ≥ 90% with Lokomat®) | Experimental | Device: Lokomat® V6 (GF ≥ 90%)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. |
| RG (RoboGait®) | Experimental | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Participation in another study.
- Joint disorders affecting mobility.
- Implanted electronic devices.
- Orthostatic hypotension.
- Severe spasticity in the lower extremities (Modified Ashworth Scale score ≥ 3).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Lok90- (GF < 90% with Lokomat®) |
| 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. | Device | Lok90+ (GF ≥ 90% with Lokomat®) |
| 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. | Device | RG (RoboGait®) |
Primary outcome
Walking Index in Spinal Cord Injury II
Time frame: 24 months
Walking Index in Spinal Cord Injury II for walking independence level assessment
5 secondary outcomes
Timed Up and Go Test
Time frame: 24 months
Berg Balance Scale
Time frame: 24 months
ASIA Lower Extremity Muscle Score
Time frame: 24 months
Spinal Cord Independence Measure (SCIM III)
Time frame: 24 months
World Health Organization Quality of Life Scale-Short Form (WHOQOL - BREF)
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lokomat® V6 (GF < 90%), Lokomat® V6 (GF ≥ 90%) and RoboGait® in people with Spinal Cord Injuries, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Index in Spinal Cord Injury II (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.