Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07040215

Effects on Subacute Stroke With Robotic Assistive Gait Training

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Gait Rehabilitation Vascular Diseases

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhua Christian Hospital

Changhua, Taiwan, 500

Location status: Recruiting

Location contact

Chen-Jou Wu

CONTACT

[email protected]

886-4-7238595 ext. 8377

Su-Fen Liao

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Freewalk lower limb Robotic Assistive Gait Training

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

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.

Primary outcomes

  1. Gait Speed

    Time frame: 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.

  2. Step Length

    Time frame: 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)

  3. Toe Clearance

    Time frame: 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).

  4. Timed Up and Go Test (TUG)

    Time frame: 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.

  5. Functional Independence Measure (FIM)

    Time frame: 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 outcomes

  1. Berg Balance Scale (BBS)

    Time frame: 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.

  2. 30-Second Chair Stand Test (30-CST)

    Time frame: 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.

  3. Surface Electromyography (sEMG)

    Time frame: 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).

  4. Short Form-12 Health Survey (SF-12)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Office of Human Subject Protection Changhua Christian Hospital

CONTACT

[email protected]

886-4-7238595 ext. 8377

Sponsors and collaborators

Lead sponsor

Changhua Christian Hospital

Other

Registry information

Official study title

The Effectiveness of Subacute Stroke Patients Receiving Robotic Assisted Gait Training

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.