Post-stroke Anxiety, Post-stroke Depression, Post-stroke Fatigue, Quality of Life, Stroke
Conditions
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.
Interventions
DEVICERoboGait® Robotic Gait Training
RoboGait® is a robotic lower limb orthosis system with adjustable dynamic body weight support, synchronized treadmill, and biofeedback software. Participants will receive robotic-assisted gait training 2 days per week for 6 weeks, in addition to conventional rehabilitation 5 days per week.
DEVICETreadmill Walking Training
Participants will receive treadmill walking sessions 2 days per week for 6 weeks, combined with conventional rehabilitation 5 days per week. The treadmill sessions will be matched in duration and intensity to the robotic training sessions in the experimental arm.
Sponsors
Meltem Gunes Akinci
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed