Effects of Robotic Rehabilitation on Quality of Life, Mood, and Fatigue After Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMeltem Gunes Akinci
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
RoboGait® Robotic Gait Training
DeviceRoboGait® 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 Training
DeviceParticipants 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Conventional + Robotic RehabilitationExperimental treatment 1 intervention
Group B: Conventional + Treadmill TrainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)Secondary outcomes
1
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.
Time frame
Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)2
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.
Time frame
Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)3
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.
Time frame
Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Meltem Gunes Akinci
Lead sponsor
Pamukkale University
Sponsor institution
Source ClinicalTrials.gov
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