Effects of Combined Robotic and Conventional Lower Limb Rehabilitation on Quality of Life, Depression, Anxiety, and Fatigue After Stroke: A Randomized Controlled Trial
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
- Stroke-Specific Quality of Life Scale (SS-QoL)
研究概览
简要总结
Stroke is a major cause of long-term disability and is often associated with reduced quality of life, depression, anxiety, and fatigue. Rehabilitation plays a key role in recovery, and robotic-assisted gait training provides intensive, repetitive, and individualized therapy. However, its effects on psychological outcomes and quality of life are not fully established.
This randomized controlled trial will compare conventional rehabilitation combined with robotic-assisted gait training to conventional rehabilitation combined with treadmill training in stroke survivors. Both groups will receive treatment 5 days per week for 6 weeks.
Assessments will be conducted at baseline, after 6 weeks of treatment, and at 3 months after treatment. The primary outcome is quality of life. Secondary outcomes include depression, anxiety, and fatigue. The results of this study will provide new evidence on the benefits of robotic rehabilitation for improving both physical and psychological well-being after stroke.
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
- Single (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
- 否
入选标准
- •Age between 18 and 75 years
- •History of ischemic or hemorrhagic stroke at least 3 months prior to enrollment
- •Mini Mental State Examination (MMSE) score of 24 or higher
- •Modified Ashworth Scale score < 2 in the lower extremities
排除标准
- •Severe cognitive or communication impairment
- •Mobility 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 significant pulmonary disease
- •High fracture risk due to severe osteoporosis
- •Ambulation difficulty caused by lower extremity musculoskeletal disorders
- •Severe psychosis or neurosis
- •Modified Ashworth Scale score > 3 in the lower extremities
研究组 & 干预措施
Conventional + Robotic Rehabilitation
Participants in this arm will receive conventional rehabilitation (stretching, strengthening, balance and coordination, postural control, and gait training) 5 days per week for 6 weeks, combined with robotic-assisted gait training using the RoboGait® device 2 days per week for 6 weeks.
干预措施: RoboGait® Robotic Gait Training (Device)
Conventional + Treadmill Training
Participants in this arm will receive conventional rehabilitation (stretching, strengthening, balance and coordination, postural control, and gait training) 5 days per week for 6 weeks, combined with treadmill walking training 2 days per week for 6 weeks. The treadmill sessions will be matched in duration to the robotic gait training sessions of the experimental group.
干预措施: Treadmill Walking Training (Device)
结局指标
主要结局
Stroke-Specific Quality of Life Scale (SS-QoL)
时间窗: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)
The Stroke-Specific Quality of Life Scale (SS-QoL) is a validated 49-item patient-reported questionnaire assessing 12 domains including mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality. Higher scores indicate better quality of life. The primary endpoint is the change in SS-QoL score from baseline to 3 months after treatment.
次要结局
- Fatigue Severity Scale (FSS)(Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2))
- Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale(Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2))
- Hospital Anxiety and Depression Scale (HADS) - Depression Subscale(Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2))
研究者
Meltem Gunes Akinci
Assistant Professor, Department of Physical Medicine and Rehabilitation, Pamukkale University Faculty of Medicine, Denizli, Türkiye
Pamukkale University