Effects on Subacute Stroke With Robotic Assistive Gait Training

Not Applicable

Recruiting

• Conditions: Stroke; Stroke Gait Rehabilitation

• Registration Number: NCT07040215
• Lead Sponsor: Changhua Christian Hospital

Brief Summary

The goal of this randomized controlled trial is to learn about the effects of Robotic Assisted Gait Training (RAGT) combined with traditional physical therapy in subacute stroke patients. The main question it aims to answer is:

- Does RAGT combined with traditional physical therapy improve gait and functional performance in subacute stroke patients compared to traditional physical therapy alone? Participants who are subacute stroke patients will be randomly assigned to receive either both RAGT and traditional physical therapy or only traditional physical therapy. Their gait and functional performance will be assessed during the study period.

Detailed Description

The sequelae of stroke have a significant impact on patients' physical functions and quality of life. Although traditional physical therapy can help some patients regain function, its effectiveness is often limited. Therefore, exploring new rehabilitation technologies has become one of the key tasks in the medical field. Robotic Assisted Gait Training (RAGT) is an emerging technology that provides high-intensity and repetitive gait training, making it particularly suitable for patients in the post-stroke rehabilitation phase. Recent studies have shown that RAGT can significantly improve gait abilities in stroke patients, including walking speed and functional performance. Therefore, this study will adopt a randomized controlled trial design, recruiting 20 subacute stroke patients who will be randomly assigned to either a group receiving both RAGT and traditional physical therapy or a group receiving only traditional physical therapy. The study will compare differences in gait and functional performance between the two groups during the rehabilitation process, aiming to provide a foundation for future personalized and precision treatment plans.

Study Timeline

• Study First Submitted: 2025-05-15
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-07-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosed with stroke (ischemic or hemorrhagic) confirmed by medical imaging.
• Subacute phase of stroke (onset within 1 to 3 months).
• Moderate to good standing balance ability.
• Sufficient cognitive ability to understand the study and follow instructions.
• Able to participate in rehabilitation training during the study period.

Exclusion Criteria

• Body weight over 90 kg.
• Presence of other neurological disorders.
• Severe cardiovascular disease or other health conditions affecting mobility.
• Significant lower limb pain, joint contracture, or spasticity (Modified Ashworth Scale score > 3) that impairs walking.
• Diagnosed with cardiopulmonary disease that contraindicates exercise training.
• Cognitive impairment that prevents understanding of training instructions or completion of questionnaires.
• Inability to complete the rehabilitation training protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Gait Speed	Baseline and after 4 weeks of intervention	Gait speed will be calculated as distance divided duration. A timer will collect the duration (seconds, s) while subjects walk 3 meters (m, distance). The gait speed showed as (m/s) directly.
Step Length	Baseline and after 4 weeks of intervention	Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include step length (meters)
Toe Clearance	Baseline and after 4 weeks of intervention	Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include toe clearance (meters).
Timed Up and Go Test (TUG)	Baseline and after 4 weeks of intervention	Assesses functional mobility and fall risk. Participants stand up from a chair, walk 3 meters, turn around, return, and sit down. The time taken to complete the task is recorded.
Functional Independence Measure (FIM)	Baseline and after 4 weeks of intervention	Evaluates the level of a participant's independence in daily activities. The FIM includes 18 items across motor and cognitive domains, each scored from 1 (total assistance) to 7 (complete independence), with a total score range of 18 to 126.

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS)	Baseline and after 4 weeks of intervention	Assesses participants' static and dynamic balance abilities using a 14-item scale. Each item is scored from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance.
30-Second Chair Stand Test (30-CST)	Baseline and after 4 weeks of intervention	Measures lower limb strength and endurance. Participants are asked to stand up and sit down from a standard chair as many times as possible within 30 seconds, with arms crossed over the chest.
Surface Electromyography (sEMG)	Baseline and after 4 weeks of intervention	Non-invasive recording of muscle activity during walking using adhesive electrodes placed on major lower limb muscles (e.g., quadriceps, tibialis anterior, gastrocnemius).
Short Form-12 Health Survey (SF-12)	Baseline and after 4 weeks of intervention	Self-reported measure of health-related quality of life. Includes 12 questions covering 8 domains such as physical functioning, role limitations, pain, general health, vitality, social functioning, emotional role, and mental health.

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan