Effects on Subacute Stroke With Robotic Assistive Gait Training

Changhua Christian Medical Foundation

Status: Enrolling

Conditions: Stroke; Stroke Gait Rehabilitation

Treatments: Device: Freewalk lower limb Robotic Assistive Gait Training; Other: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07040215

250321

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Conventional PT

Active Comparator group

Description:

Conventional Physiotherapy

Treatment:

Other: Physiotherapy

Robotic Gait Training

Experimental group

Description:

Conventional Physiotherapy combined with Robotic Assistive Gait Training

Treatment:

Other: Physiotherapy

Device: Freewalk lower limb Robotic Assistive Gait Training