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

Meltem Gunes Akinci

Status: Not yet enrolling

Conditions: Stroke; Balance Impairment; Gait Disorder, Sensorimotor; Fear of Falling; Hemiplegia

Treatments: Device: RoboGait® Pelvic-Restricted Mode; Other: Conventional Rehabilitation; Device: RoboGait® Pelvic-Free Mode

Study type: Interventional

Funder types: Other

Identifiers

NCT07365384

E-60116787-020-690593

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• Gait impairment caused by lower extremity musculoskeletal disorders
• Severe psychosis/neurosis
• Modified Ashworth Scale > 3 in the lower extremities (severe spasticity)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation

Experimental group

Description:

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).

Treatment:

Device: RoboGait® Pelvic-Free Mode

Other: Conventional Rehabilitation

Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation

Active Comparator group

Description:

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).

Treatment:

Other: Conventional Rehabilitation

Device: RoboGait® Pelvic-Restricted Mode