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

NCT07203937 | Not Yet Recruiting

• 1 other identifier: E-60116787-020-695640
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

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.

  Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)

Secondary Outcomes (3)

• Fatigue Severity Scale (FSS)

  Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)

• Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale

  Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)

• Hospital Anxiety and Depression Scale (HADS) - Depression Subscale

  Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)

Study Arms (2)

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.

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.

Device: Treadmill Walking Training

Interventions

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.

Also known as: Robotic-Assisted Rehabilitation, Robotic-Assisted Walking Exercise

Conventional + Robotic Rehabilitation

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.

Also known as: Treadmill-based gait training

Conventional + Treadmill Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meltem Gunes Akinci: lead

Related Publications (3)

• 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.

  PMID: 38767637 BACKGROUND

• den 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.

  PMID: 36683416 BACKGROUND

• Mustafaoglu 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.

  PMID: 31989505 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Department of Physical Medicine and Rehabilitation, Pamukkale University Faculty of Medicine, Denizli, Türkiye

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share