RoboGait® Pelvic-Free Mode
DeviceRobot-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.
NCT Number: NCT07365384
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
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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).
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).
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).
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.
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.
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 (%).
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
6-level scale (0-5) evaluating functional walking ability, from non-functional ambulation to independent walking.
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Assesses motor function of the paretic lower limb (score range 0-99)
Time frame: Baseline (T0) and 4 weeks post-intervention (T1)
Self-reported questionnaire evaluating fear of falling during daily activities (higher scores indicate greater fear).
Contact information is provided by the study sponsor or research team.
Meltem Gunes Akinci
Other
Comparison of Pelvic-Free and Pelvic-Restricted Robot-Assisted Gait Training on Walking Pattern, Balance, and Fear of Falling After Stroke
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