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

Meltem Gunes Akinci

Status: Not yet enrolling

Conditions: Post-stroke Anxiety; Post-stroke Fatigue; Stroke; Quality of Life; Post-stroke Depression

Treatments: Device: RoboGait® Robotic Gait Training; Device: Treadmill Walking Training

Study type: Interventional

Funder types: Other

Identifiers

NCT07203937

E-60116787-020-695640

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Conventional + Robotic Rehabilitation

Experimental group

Description:

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.

Treatment:

Device: RoboGait® Robotic Gait Training

Conventional + Treadmill Training

Active Comparator group

Description:

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.

Treatment:

Device: Treadmill Walking Training