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

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

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

Treatments tested in this trial

  • RoboGait® Pelvic-Free Mode
  • RoboGait® Pelvic-Restricted Mode
  • Conventional Rehabilitation

Treatment groups

36 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Meltem Gunes Akinci

Lead sponsor

Pamukkale University

Sponsor institution