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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RoboGait® Pelvic-Free Mode | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale | 14-item scale assessing static and dynamic balance, scored 0-56 (higher scores indicate better balance). | 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). | 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). | 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. | 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. | 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 (%). | Baseline (T0) and 4 weeks post-intervention (T1) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Ambulation Category (FAC) | 6-level scale (0-5) evaluating functional walking ability, from non-functional ambulation to independent walking. | Baseline (T0) and 4 weeks post-intervention (T1) |
| Motricity Index - Lower Limb |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meltem Güneş Akıncı, MD | Contact | +902582966000 | mgakinci@pau.edu.tr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36343085 | Result | 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. | |
| 30728040 | Result | Aurich-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. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| RoboGait® Pelvic-Restricted Mode | Device | 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 Rehabilitation | Other | 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. |
|
Assesses motor function of the paretic lower limb (score range 0-99)
| 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). | Baseline (T0) and 4 weeks post-intervention (T1) |
| 30876445 | Result | Alingh 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |