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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-07-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional + Robotic Rehabilitation

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.

Group Type EXPERIMENTAL

RoboGait® Robotic Gait Training

Intervention Type 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.

Conventional + Treadmill Training

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.

Group Type ACTIVE_COMPARATOR

Treadmill Walking Training

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Robotic-Assisted Rehabilitation Robotic-Assisted Walking Exercise Treadmill-based gait training

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No