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Research Project on the Clinical Outcomes and Health Economics of Gait Training with SensibleSTEP Gait Rehabilitation Robots versus Conventional Human Assisted Ground Based Gait Training

Research Project on the Clinical Outcomes and Health Economics of Gait Training with SensibleSTEP Gait Rehabilitation Robots versus Conventional Human Assisted Ground Based Gait Training

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250903004
Enrollment
159
Registered
2025-09-03
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subacute stroke with severe walking impairment Stroke Cerebrovascular Disorders Gait Walking Rehabilitation Robotics Physical Therapy Modalities Cost-Benefit Analysis Health Economics Disability Evaluation Quality of Life Motor Activity Recovery of Function Randomized Controlled Trial Postural Balance

Interventions

Robotic Gait Training At Hospital ,using SensibleSTEP gait training robot, as In-patient or Out-patient , at least 2 sessions per week until completion of 20 sessions. ,Conventional Gait Training At H
Experimental Device,Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
Robotic Gait Training At Hospital,Conventional Gait Training at Hospital,Conventional Gait Training in the commuinity

Sponsors

Thailand Center of Excellence for Life Sciences (TCELS)
Lead Sponsor
TMGI co.ltd
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Diagnosed with firstever stroke in subacute phase less than 6 months from onset 2. Severe walking impairment unable to walk independently Functional Ambulation Classification FAC score 0 to 3 3. Able to participate in rehabilitation at least two sessions per week for a minimum of 20 sessions 4. Medically stable to undergo gait training as determined by treating physician 5. Able to provide informed consent or have a legal representative provide consent

Exclusion criteria

Exclusion criteria: 1. Previous history of stroke prior to the current episode 2. Ability to walk independently (Functional Ambulation Classification FAC score 4 or 5) 3. Contraindications to gait training such as unstable cardiovascular conditions or severe orthopedic issues 4. Severe cognitive impairment preventing ability to follow instructions for rehabilitation 5. Participation in another interventional study that may interfere with the protocol 6. Life expectancy less than 6 months due to other comorbidities 7. Pregnancy or breastfeeding 8. Inability to commit to the required frequency and duration of rehabilitation sessions

Design outcomes

Primary

MeasureTime frame
Walking Dependency Immediately after completion of 20 sessions of training Functional Amubulation Classification (FAC)

Secondary

MeasureTime frame
Walking speed and Balance Immediately after completion of 20 sessions of training Timed Up and Go Test (TUGT)

Countries

Thailand

Contacts

Public Contactparit wongphaet

mahidol univerisit

spine.clinic@yahoo.com0829532225

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026