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临床试验/NCT07365384
NCT07365384尚未招募不适用

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

Meltem Gunes Akinci0 个研究点目标入组 36 人开始时间: 2026年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
主要终点
Berg Balance Scale

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

研究组 & 干预措施

Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation

Experimental

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).

干预措施: RoboGait® Pelvic-Free Mode (Device)

Pelvic-Free Robot-Assisted Gait Training + Conventional Rehabilitation

Experimental

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).

干预措施: Conventional Rehabilitation (Other)

Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation

Active Comparator

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).

干预措施: RoboGait® Pelvic-Restricted Mode (Device)

Pelvic-Restricted Robot-Assisted Gait Training + Conventional Rehabilitation

Active Comparator

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).

干预措施: Conventional Rehabilitation (Other)

结局指标

主要结局

Berg Balance Scale

时间窗: Baseline (T0) and 4 weeks post-intervention (T1)

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

Gait Speed

时间窗: Baseline (T0) and 4 weeks post-intervention (T1)

Gait speed will be assessed using the Zebris FDM-T treadmill system and expressed in meters per second (m/s).

Step Length

时间窗: Baseline (T0) and 4 weeks post-intervention (T1)

Step length will be measured with the Zebris FDM-T treadmill system and reported in centimeters (cm).

Cadence

时间窗: Baseline (T0) and 4 weeks post-intervention (T1)

Cadence will be recorded using the Zebris FDM-T treadmill system and expressed in steps per minute.

Double Support Time

时间窗: Baseline (T0) and 4 weeks post-intervention (T1)

Double support time will be assessed with the Zebris FDM-T treadmill system and expressed as percentage (%) of the gait cycle.

Temporal Symmetry Index

时间窗: Baseline (T0) and 4 weeks post-intervention (T1)

Temporal symmetry index will be calculated from gait analysis with the Zebris FDM-T treadmill system and expressed as a percentage (%).

次要结局

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

研究者

发起方
Meltem Gunes Akinci
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Meltem Gunes Akinci

Assistant Professor of Physical Medicine and Rehabilitation, Pamukkale University

Pamukkale University

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