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

Официальное название

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

Обзор

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

Вмешательства

• Устройство 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.
• Устройство 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.
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (3)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07365384 · E-60116787-020-690593

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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