Effects of Robotic Rehabilitation on Quality of Life, Mood, and Fatigue After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RoboGait® Robotic Gait Training, Treadmill Walking Training.
- Who it may be relevant to
- Registry conditions: Stroke, Post-stroke Depression, Post-stroke Anxiety, Post-stroke Fatigue. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Combined Robotic and Conventional Lower Limb Rehabilitation on Quality of Life, Depression, Anxiety, and Fatigue After Stroke: A Randomized Controlled Trial
Overview
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
- Device RoboGait® 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. - Device Treadmill 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.
Primary outcome measures
- Stroke-Specific Quality of Life Scale (SS-QoL) [Time frame: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)]
Secondary outcome measures (3)
- Fatigue Severity Scale (FSS) [Time frame: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)]
- Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale [Time frame: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)]
- Hospital Anxiety and Depression Scale (HADS) - Depression Subscale [Time frame: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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. PMID 38767637
- 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. PMID 36683416
- 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. PMID 31989505
Identifiers
NCT: NCT07203937 · E-60116787-020-695640