Effects of Robotic Rehabilitation on Quality of Life, Mood, and Fatigue After Stroke

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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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Post-stroke Anxiety Post-stroke Depression Post-stroke Fatigue Quality of Life Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Robotic-Assisted Rehabilitation, Robotic-Assisted Walking Exercise

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.

Other names: Treadmill-based gait training

Primary outcomes

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.

Secondary outcomes

Fatigue Severity Scale (FSS)

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Meltem Gunes Akinci

Other

Registry information

Official study title

Effects of Combined Robotic and Conventional Lower Limb Rehabilitation on Quality of Life, Depression, Anxiety, and Fatigue After Stroke: A Randomized Controlled Trial

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Oct 2, 2025
Registry last updated: Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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