StrokeNCT07365384
Pelvic-Restricted vs. Pelvic-Free Robot-Assisted Gait Training in Stroke Patients
A study testing RoboGait® Pelvic-Free Mode, RoboGait® Pelvic-Restricted Mode and Conventional Rehabilitation in people with Stroke and Hemiplegia, run by Meltem Gunes Akinci.
Trial summary
This randomized controlled clinical trial aims to compare the effects of pelvic-free versus pelvic-restricted robot-assisted gait training (RAGT) on gait pattern, balance, and fear of falling in stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Hemiplegia, Gait Disorder, Sensorimotor
- What is being tested?
- RoboGait® Pelvic-Free Mode, RoboGait® Pelvic-Restricted Mode and Conventional Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- History of stroke more than 6 months prior
- Presence of hemiplegia-related gait disorder
- Functional Ambulation Category (FAC) score ≥ 2
- Ability to walk independently prior to stroke
Who cannot join
- Severe cognitive or communication impairment
- Movement limitations due to joint contracture or deformity
- Presence of open wounds or pressure ulcers
- Uncontrolled hypertension or orthostatic hypotension
- Severe cardiovascular disease, heart failure, cancer, or serious pulmonary disease
- High risk of fracture due to severe osteoporosis
Show all 9Show fewer
- Gait impairment caused by lower extremity musculoskeletal disorders
- Severe psychosis/neurosis
- Modified Ashworth Scale > 3 in the lower extremities (severe spasticity)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Pelvic-Free and Pelvic-Restricted Robot-Assisted Gait Training on Walking Pattern, Balance, and Fear of Falling After Stroke
This randomized controlled clinical trial aims to compare the effects of pelvic-free versus pelvic-restricted robot-assisted gait training (RAGT) on gait pattern, balance, and fear of falling in stroke patients. Stroke survivors often experience gait impairments, reduced balance, and fear of falling, which limit independence and quality of life. Conventional physiotherapy requires high intensity and repetition but is restricted by therapist capacity. Robotic gait systems provide intensive, repetitive, and safe training; however, most limit pelvic motion, potentially disrupting natural gait patterns and balance strategies.
A total of 36 participants with chronic stroke (≥6 months post-stroke, age ≥18 years, hemiplegic gait disorder, Functional Ambulation Category ≥2) will be randomized into two groups: (1) pelvic-free RAGT plus conventional rehabilitation, or (2) pelvic-restricted RAGT plus conventional rehabilitation. Interventions will consist of 8 RAGT sessions (twice weekly) and 20 conventional rehabilitation sessions (five times weekly) over 4 weeks.
Read more
Primary outcomes include gait analysis parameters (gait speed, step length, cadence, temporal symmetry index) and clinical measures such as the Berg Balance Scale, Functional Ambulation Category, Motricity Index (lower limb), and Falls Efficacy Scale-International. Assessments will be performed at baseline and after 4 weeks of treatment.
The study hypothesizes that pelvic-free RAGT will improve gait symmetry, balance, and reduce fear of falling more effectively than pelvic-restricted training. Results are expected to provide evidence supporting the integration of pelvic-free robotic gait systems into post-stroke rehabilitation to enhance functional recovery and patient confidence
- Being tested
- RoboGait® Pelvic-Free Mode, RoboGait® Pelvic-Restricted Mode, Conventional Rehabilitation
- Medical subject headings
- Stroke, Hemiplegia, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoboGait® Pelvic-Free ModeDevice
Robot-assisted gait training using the RoboGait® system in pelvic-free mode. Participants receive 8 sessions (2 per week for 4 weeks) in addition to conventional rehabilitation.
RoboGait® Pelvic-Restricted ModeDevice
Robot-assisted gait training using the RoboGait® system in pelvic-restricted mode. Participants receive 8 sessions (2 per week for 4 weeks) in addition to conventional rehabilitation.
Conventional RehabilitationOther
Standard physiotherapy program consisting of 20 sessions (5 per week for 4 weeks) focused on mobility, strengthening, and functional training. Applied to all participants in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation | Experimental | Participants will receive 8 sessions of pelvic-free robot-assisted gait training with RoboGait® (2 sessions per week for 4 weeks) in addition to conventional rehabilitation (5 sessions per week for 4 weeks). Receives: Device: RoboGait® Pelvic-Free Mode; Other: Conventional Rehabilitation |
| Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation | Active comparator | Participants will receive 8 sessions of pelvic-restricted robot-assisted gait training with RoboGait® (2 sessions per week for 4 weeks) in addition to conventional rehabilitation (5 sessions per week for 4 weeks). Receives: Device: RoboGait® Pelvic-Restricted Mode; Other: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
14-item scale assessing static and dynamic balance, scored 0-56 (higher scores indicate better balance).
Measured: Baseline (T0) and 4 weeks post-intervention (T1)
Gait Speed
Gait speed will be assessed using the Zebris FDM-T treadmill system and expressed in meters per second (m/s).
Measured: Baseline (T0) and 4 weeks post-intervention (T1)
Step Length
Step length will be measured with the Zebris FDM-T treadmill system and reported in centimeters (cm).
Measured: Baseline (T0) and 4 weeks post-intervention (T1)
Cadence
Cadence will be recorded using the Zebris FDM-T treadmill system and expressed in steps per minute.
Measured: Baseline (T0) and 4 weeks post-intervention (T1)
Double Support Time
Double support time will be assessed with the Zebris FDM-T treadmill system and expressed as percentage (%) of the gait cycle.
Measured: Baseline (T0) and 4 weeks post-intervention (T1)
Temporal Symmetry Index
Temporal symmetry index will be calculated from gait analysis with the Zebris FDM-T treadmill system and expressed as a percentage (%).
Measured: Baseline (T0) and 4 weeks post-intervention (T1)
Secondary outcomes (3)
Functional Ambulation Category (FAC)
6-level scale (0-5) evaluating functional walking ability, from non-functional ambulation to independent walking.
Measured: Baseline (T0) and 4 weeks post-intervention (T1)
Motricity Index - Lower Limb
Assesses motor function of the paretic lower limb (score range 0-99)
Measured: Baseline (T0) and 4 weeks post-intervention (T1)
Falls Efficacy Scale-International (FES-I)
Self-reported questionnaire evaluating fear of falling during daily activities (higher scores indicate greater fear).
Measured: Baseline (T0) and 4 weeks post-intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meltem Gunes Akinci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meltem Gunes Akinci, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365384
- Sponsor's protocol ID
- E-60116787-020-690593
- Status last verified
- Jan 2026
- First submitted
- 26 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee J, Chun MH, Seo YJ, Lee A, Choi J, Son C. Effects of a lower limb rehabilitation robot with various training modes in patients with stroke: A randomized controlled trial. Medicine (Baltimore). 2022 Nov 4;101(44):e31590. doi: 10.1097/MD.0000000000031590.
PubMed 36343085Aurich-Schuler T, Gut A, Labruyere R. The FreeD module for the Lokomat facilitates a physiological movement pattern in healthy people - a proof of concept study. J Neuroeng Rehabil. 2019 Feb 6;16(1):26. doi: 10.1186/s12984-019-0496-x.
PubMed 30728040Alingh JF, Weerdesteyn V, Nienhuis B, van Asseldonk EHF, Geurts ACH, Groen BE. Immediate after-effects of robot-assisted gait with pelvic support or pelvic constraint on overground walking in healthy subjects. J Neuroeng Rehabil. 2019 Mar 15;16(1):40. doi: 10.1186/s12984-019-0506-z.
PubMed 30876445
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pelvic-Free and Pelvic-Restricted Robot-Assisted Gait Training on Walking Pattern, Balance, and Fear of Falling After Stroke
- ClinicalTrials.gov ID
- NCT07365384
- Acronym / sponsor ID
- E-60116787-020-690593
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Meltem Gunes AkinciUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 26 Jan 2026 (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 randomized controlled clinical trial aims to compare the effects of pelvic-free versus pelvic-restricted robot-assisted gait training (RAGT) on gait pattern, balance, and fear of falling in stroke patients. Stroke survivors often experience gait impairments, reduced balance, and fear of falling, which limit independence and quality of life. Conventional physiotherapy requires high intensity and repetition but is restricted by therapist capacity. Robotic gait systems provide intensive, repetitive, and safe training; however, most limit pelvic motion, potentially disrupting natural gait patterns and balance strategies.
A total of 36 participants with chronic stroke (≥6 months post-stroke, age ≥18 years, hemiplegic gait disorder, Functional Ambulation Category ≥2) will be randomized into two groups: (1) pelvic-free RAGT plus conventional rehabilitation, or (2) pelvic-restricted RAGT plus conventional rehabilitation. Interventions will consist of 8 RAGT sessions (twice weekly) and 20 conventional rehabilitation sessions (five times weekly) over 4 weeks.
Primary outcomes include gait analysis parameters (gait speed, step length, cadence, temporal symmetry index) and clinical measures such as the Berg Balance Scale, Functional Ambulation Category, Motricity Index (lower limb), and Falls Efficacy Scale-International. Assessments will be performed at baseline and after 4 weeks of treatment.
The study hypothesizes that pelvic-free RAGT will improve gait symmetry, balance, and reduce fear of falling more effectively than pelvic-restricted training. Results are expected to provide evidence supporting the integration of pelvic-free robotic gait systems into post-stroke rehabilitation to enhance functional recovery and patient confidence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation | Experimental | Device: RoboGait® Pelvic-Free Mode, Other: Conventional RehabilitationParticipants will receive 8 sessions of pelvic-free robot-assisted gait training with RoboGait® (2 sessions per week for 4 weeks) in addition to conventional rehabilitation (5 sessions per week for 4 weeks). |
| Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation | Active comparator | Device: RoboGait® Pelvic-Restricted Mode, Other: Conventional RehabilitationParticipants will receive 8 sessions of pelvic-restricted robot-assisted gait training with RoboGait® (2 sessions per week for 4 weeks) in addition to conventional rehabilitation (5 sessions per week for 4 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- History of stroke more than 6 months prior
- Presence of hemiplegia-related gait disorder
- Functional Ambulation Category (FAC) score ≥ 2
- Ability to walk independently prior to stroke
Key exclusion criteria (9 listed)
- Severe cognitive or communication impairment
- Movement limitations due to joint contracture or deformity
- Presence of open wounds or pressure ulcers
- Uncontrolled hypertension or orthostatic hypotension
- Severe cardiovascular disease, heart failure, cancer, or serious pulmonary disease
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 |
|---|---|---|
| RoboGait® Pelvic-Free ModeRobot-assisted gait training using the RoboGait® system in pelvic-free mode. Participants receive 8 sessions (2 per week for 4 weeks) in addition to conventional rehabilitation. | Device | Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation |
| RoboGait® Pelvic-Restricted ModeRobot-assisted gait training using the RoboGait® system in pelvic-restricted mode. Participants receive 8 sessions (2 per week for 4 weeks) in addition to conventional rehabilitation. | Device | Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation |
| Conventional RehabilitationStandard physiotherapy program consisting of 20 sessions (5 per week for 4 weeks) focused on mobility, strengthening, and functional training. Applied to all participants in both groups. | Other | Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation, Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation |
Primary outcome
Berg Balance Scale
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
14-item scale assessing static and dynamic balance, scored 0-56 (higher scores indicate better balance).
Gait Speed
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Gait speed will be assessed using the Zebris FDM-T treadmill system and expressed in meters per second (m/s).
Step Length
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Step length will be measured with the Zebris FDM-T treadmill system and reported in centimeters (cm).
Cadence
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Cadence will be recorded using the Zebris FDM-T treadmill system and expressed in steps per minute.
Double Support Time
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Double support time will be assessed with the Zebris FDM-T treadmill system and expressed as percentage (%) of the gait cycle.
Temporal Symmetry Index
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Temporal symmetry index will be calculated from gait analysis with the Zebris FDM-T treadmill system and expressed as a percentage (%).
3 secondary outcomes
Functional Ambulation Category (FAC)
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Motricity Index - Lower Limb
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Falls Efficacy Scale-International (FES-I)
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Results publication: PubMed 36343085Lee J, Chun MH, Seo YJ, Lee A, Choi J, Son C. Effects of a lower limb rehabilitation robot with various training modes in patients with stroke: A randomized controlled trial. Medicine (Baltimore). 2022 Nov 4;101(44):e31590. doi: 10.1097/MD.0000000000031590.
- Results publication: PubMed 30728040Aurich-Schuler T, Gut A, Labruyere R. The FreeD module for the Lokomat facilitates a physiological movement pattern in healthy people - a proof of concept study. J Neuroeng Rehabil. 2019 Feb 6;16(1):26. doi: 10.1186/s12984-019-0496-x.
- Results publication: PubMed 30876445Alingh JF, Weerdesteyn V, Nienhuis B, van Asseldonk EHF, Geurts ACH, Groen BE. Immediate after-effects of robot-assisted gait with pelvic support or pelvic constraint on overground walking in healthy subjects. J Neuroeng Rehabil. 2019 Mar 15;16(1):40. doi: 10.1186/s12984-019-0506-z.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing RoboGait® Pelvic-Free Mode, RoboGait® Pelvic-Restricted Mode and Conventional Rehabilitation in people with Stroke and Hemiplegia, run by Meltem Gunes Akinci.
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 9 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: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meltem Güneş Akıncı, MD (+902582966000, mgakinci@pau.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Baseline (T0) and 4 weeks post-intervention (T1)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07365384, which also lists 3 linked publications.
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 26 Jan 2026.