StrokeNCT07203937
Effects of Robotic Rehabilitation on Quality of Life, Mood, and Fatigue After Stroke
A study testing RoboGait® Robotic Gait Training and Treadmill Walking Training in people with Stroke and Post-stroke Depression, run by Meltem Gunes Akinci.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Post-stroke Depression, Post-stroke Anxiety
- What is being tested?
- RoboGait® Robotic Gait Training and Treadmill Walking Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Ambulation difficulty caused by lower extremity musculoskeletal disorders
- Severe psychosis or neurosis
- Modified Ashworth Scale score > 3 in the lower extremities
About this study
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
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.
- Being tested
- RoboGait® Robotic Gait Training, Treadmill Walking Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoboGait® Robotic Gait TrainingDevice
Also called Robotic-Assisted Rehabilitation, Robotic-Assisted Walking Exercise
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.
Treadmill Walking TrainingDevice
Also called Treadmill-based gait 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: RoboGait® Robotic Gait Training |
| 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. Receives: Device: Treadmill Walking Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)
Secondary outcomes (3)
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.
Measured: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)
Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale
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.
Measured: 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.
Measured: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start15 Jan 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meltem Gunes Akinci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meltem Gunes Akinci, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203937
- Sponsor's protocol ID
- E-60116787-020-695640
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 38767637den 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.
PubMed 36683416Mustafaoglu 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.
PubMed 31989505
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07203937
- Acronym / sponsor ID
- E-60116787-020-695640
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Meltem Gunes AkinciUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional + Robotic Rehabilitation | Experimental | Device: RoboGait® Robotic Gait TrainingParticipants 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. |
| Conventional + Treadmill Training | Active comparator | Device: Treadmill Walking TrainingParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoboGait® Robotic Gait TrainingAlso: Robotic-Assisted Rehabilitation, Robotic-Assisted Walking ExerciseRoboGait® 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 | Conventional + Robotic Rehabilitation |
| Treadmill Walking TrainingAlso: Treadmill-based gait trainingParticipants 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. | Device | Conventional + Treadmill Training |
Primary outcome
Stroke-Specific Quality of Life Scale (SS-QoL)
Time frame: 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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 38767637Haolin 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.
- Background: PubMed 36683416den 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.
- Background: PubMed 31989505Mustafaoglu 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing RoboGait® Robotic Gait Training and Treadmill Walking Training in people with Stroke and Post-stroke Depression, run by Meltem Gunes Akinci.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke-Specific Quality of Life Scale (SS-QoL) (time frame: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07203937, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.