Effects on Subacute Stroke With Robotic Assistive Gait Training

NCT07040215 | Recruiting

• 1 other identifier: 250321
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Stroke Gait Rehabilitation

Keywords

physiotherapy; Robotic Assistive Gait Training

Outcome Measures

Primary Outcomes (5)

• Gait Speed

  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.

  Baseline and after 4 weeks of intervention

• Step Length

  Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include step length (meters)

  Baseline and after 4 weeks of intervention

• Toe Clearance

  Objective assessment of gait performance using two inertial sensors attached to the shoes. Measures include toe clearance (meters).

  Baseline and after 4 weeks of intervention

• Timed Up and Go Test (TUG)

  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.

  Baseline and after 4 weeks of intervention

• Functional Independence Measure (FIM)

  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.

  Baseline and after 4 weeks of intervention

Secondary Outcomes (4)

• Berg Balance Scale (BBS)

  Baseline and after 4 weeks of intervention

• 30-Second Chair Stand Test (30-CST)

  Baseline and after 4 weeks of intervention

• Surface Electromyography (sEMG)

  Baseline and after 4 weeks of intervention

• Short Form-12 Health Survey (SF-12)

  Baseline and after 4 weeks of intervention

Study Arms (2)

Conventional PT

ACTIVE COMPARATOR

Conventional Physiotherapy

Other: Physiotherapy

Robotic Gait Training

EXPERIMENTAL

Conventional Physiotherapy combined with Robotic Assistive Gait Training

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

Interventions

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.

Robotic Gait Training

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.

Conventional PT; Robotic Gait Training

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Changhua Christian Hospital

Changhua, Taiwan, 500, Taiwan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Su-Fen Liao

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Office of Human Subject Protection Changhua Christian Hospital

CONTACT

886-4-7238595; d9010@cch.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)