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

Official title

Comparison of Pelvic-Free and Pelvic-Restricted Robot-Assisted Gait Training on Walking Pattern, Balance, and Fear of Falling After Stroke

Overview

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

Interventions

• Device RoboGait® Pelvic-Free Mode
  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.
• Device RoboGait® Pelvic-Restricted Mode
  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.
• Other 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.

Primary outcome measures

• Berg Balance Scale [Time frame: Baseline (T0) and 4 weeks post-intervention (T1)]
• Gait Speed [Time frame: Baseline (T0) and 4 weeks post-intervention (T1)]
• Step Length [Time frame: Baseline (T0) and 4 weeks post-intervention (T1)]
• Cadence [Time frame: Baseline (T0) and 4 weeks post-intervention (T1)]
• Double Support Time [Time frame: Baseline (T0) and 4 weeks post-intervention (T1)]
• Temporal Symmetry Index [Time frame: Baseline (T0) and 4 weeks post-intervention (T1)]

Secondary outcome measures (3)

• Functional Ambulation Category (FAC) [Time frame: Baseline (T0) and 4 weeks post-intervention (T1)]
• Motricity Index - Lower Limb [Time frame: Baseline (T0) and 4 weeks post-intervention (T1)]
• Falls Efficacy Scale-International (FES-I) [Time frame: Baseline (T0) and 4 weeks post-intervention (T1)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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. PMID 36343085
• 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. PMID 30728040
• 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. PMID 30876445

Identifiers

NCT: NCT07365384 · E-60116787-020-690593

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗