NCT07203937

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Meltem Gunes Akinci · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Stroke
• Post-stroke Depression
• Post-stroke Anxiety
• Post-stroke Fatigue
• Quality of Life

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-10-02
• Last updated: 2026-01-26