Effects of Robotic Rehabilitation on Quality of Life, Mood, and Fatigue After Stroke
- Conditions
- StrokePost-stroke DepressionPost-stroke AnxietyPost-stroke FatigueQuality of Life
- Registration Number
- NCT07203937
- Lead Sponsor
- Meltem Gunes Akinci
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Stroke-Specific Quality of Life Scale (SS-QoL) 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.
- Secondary Outcome Measures
Name Time Method Fatigue Severity Scale (FSS) Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2) The Fatigue Severity Scale (FSS) is a 9-item questionnaire evaluating fatigue severity. Each item is scored from 0 to 7, with higher mean scores indicating greater fatigue.
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2) The HADS-Anxiety subscale consists of 7 items rated on a 4-point Likert scale. Scores range from 0-21, with higher scores indicating greater anxiety.
Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2) The HADS-Depression subscale consists of 7 items rated on a 4-point Likert scale. Scores range from 0-21, with higher scores indicating greater depressive symptoms.