Effects on Subacute Stroke With Robotic Assistive Gait Training

NCT ID: NCT07040215

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-04-30

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.

Conditions

Stroke; Stroke Gait Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional PT

Conventional Physiotherapy

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: OTHER

Participants in this group will receive conventional stroke rehabilitation therapy (including sit to stand, balance and gait training) 5 days/week, 30 minutes per session. Intervention Duration: 4 weeks.

Robotic Gait Training

Conventional Physiotherapy combined with Robotic Assistive Gait Training

Group Type: EXPERIMENTAL

Freewalk lower limb Robotic Assistive Gait Training

Intervention Type: DEVICE

Participants in this group will receive robotic-assisted gait training three times per week (every other day) for 30 minutes per session, using the FREE Walk exoskeleton device (FREE Bionics, Taiwan). The device assists with walking, standing, and sitting. A physical therapist will help the participant wear the exoskeleton and supervise the training, adjusting the level of robotic support and intensity based on the participant's ability. In addition to RAGT, participants will receive conventional stroke rehabilitation therapy (including sit to stand, balance and gait training) on the remaining weekdays (2 days/week), 30 minutes per session.

Intervention Duration: 4 weeks.

Physiotherapy

Intervention Type: OTHER

Participants in this group will receive conventional stroke rehabilitation therapy (including sit to stand, balance and gait training) 5 days/week, 30 minutes per session. Intervention Duration: 4 weeks.

Interventions

Freewalk lower limb Robotic Assistive Gait Training

Participants in this group will receive robotic-assisted gait training three times per week (every other day) for 30 minutes per session, using the FREE Walk exoskeleton device (FREE Bionics, Taiwan). The device assists with walking, standing, and sitting. A physical therapist will help the participant wear the exoskeleton and supervise the training, adjusting the level of robotic support and intensity based on the participant's ability. In addition to RAGT, participants will receive conventional stroke rehabilitation therapy (including sit to stand, balance and gait training) on the remaining weekdays (2 days/week), 30 minutes per session.

Intervention Duration: 4 weeks.

Intervention Type: DEVICE

Physiotherapy

Participants in this group will receive conventional stroke rehabilitation therapy (including sit to stand, balance and gait training) 5 days/week, 30 minutes per session. Intervention Duration: 4 weeks.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhua Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Su-Fen Liao

Role: PRINCIPAL_INVESTIGATOR

Changhua Christian Hospital

Locations

Changhua Christian Hospital

Changhua, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Office of Human Subject Protection Changhua Christian Hospital

Role: CONTACT

d9010@cch.org.tw

886-4-7238595 ext. 8377

Facility Contacts

Chen-Jou Wu

Role: primary

d9010@cch.org.tw

886-4-7238595 ext. 8377

Other Identifiers

250321

Identifier Type: -

Identifier Source: org_study_id