Pelvic-Restricted vs. Pelvic-Free Robot-Assisted Gait Training in Stroke Patients

ConditionsStroke Hemiplegia Gait Disorder, Sensorimotor Balance Impairment Fear of Falling

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorMeltem Gunes Akinci

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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 intervention
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.

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: Pelvic-Free Robot-Assisted Gait Training + Conventional RehabilitationExperimental treatment 2 interventions

Group B: Pelvic-Restricted Robot-Assisted Gait Training + Conventional RehabilitationActive comparator 2 interventions

Trial outcomes

Primary outcomes

Berg Balance Scale

14-item scale assessing static and dynamic balance, scored 0-56 (higher scores indicate better balance).

Time frame