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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional + Robotic Rehabilitation | Experimental | 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. |
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| Conventional + Treadmill Training | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RoboGait® Robotic Gait Training | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke-Specific Quality of Life Scale (SS-QoL) | 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. | Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2) |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale (FSS) | 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. | Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2) |
| Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38767637 | Background | Haolin T, Yuanbin Y, Hu Z, Wenjing Z, Jing Z, Jingfeng T, Long HE, Xuechao LI, Qinxuan S, Mei S. Efficacy of Daoyin combined with lower limb robot as a comprehensive rehabilitation intervention for stroke patients: a randomized controlled trial. J Tradit Chin Med. 2024 Jun;44(3):530-536. doi: 10.19852/j.cnki.jtcm.20240322.002. | |
| 36683416 |
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Individual participant data will not be shared due to privacy concerns and institutional data protection policies. Only summary results will be disseminated through scientific publications and conference presentations.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Treadmill Walking Training | Device | 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. |
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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. |
| Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2) |
| Hospital Anxiety and Depression Scale (HADS) - Depression Subscale | 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. | Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2) |
| den Brave M, Beaudart C, de Noordhout BM, Gillot V, Kaux JF. Effect of robot-assisted gait training on quality of life and depression in neurological impairment: A systematic review and meta-analysis. Clin Rehabil. 2023 Jul;37(7):876-890. doi: 10.1177/02692155231152567. Epub 2023 Jan 22. |
| 31989505 | Background | Mustafaoglu R, Erhan B, Yeldan I, Gunduz B, Tarakci E. Does robot-assisted gait training improve mobility, activities of daily living and quality of life in stroke? A single-blinded, randomized controlled trial. Acta Neurol Belg. 2020 Apr;120(2):335-344. doi: 10.1007/s13760-020-01276-8. Epub 2020 Jan 28. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |