Subacute Stroke SensibleSTEP Multicenter Randomized Controlled Trial

Research Project to Study Clinical Effectiveness and Health Economics of SensibleSTEP Robotic Gait Rehabilitation of Subacute Non-ambulatory Stroke Patients Versus Traditional Ground Based Human Assisted Gait Training

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251117009

Enrollment

159

Registered

2025-11-17

Start date

2025-10-28

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 nonambulatory first ever stroke patients stroke , hemiplegia, walking, rehabilitation, robotics

Interventions

Gait Training with SensibleSTEP Gait Rehabilitation Robots at Hospital 30 mins per session, at least twice a week for 20 sessions under supervision of trained physiotherapists,Conventional Gait Traini

Experimental Device,Active Comparator Behavioral,Active Comparator Behavioral

Robotic Gait Training,Conventional Gait Training At Hospital,Conventional Gait Training At Home

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.first ever stroke 2.less than 6 months before enrollment 3.dependent in walking (FAC score 0,1,2,or 3) 4.give informed consent 5.can understand instruction and cooperate adequately with gait training

Exclusion criteria

Exclusion criteria: 1.existing orthostatic hypotension , can not tolerate 10 minutes of uprigthing on tilt-table 2.poor trunk control, can not maintain upright sitting despite using own arm(s) as support, while sitting 3.active wound at weight bearing areas at feet and body harness 4.severe painful MSK condition , or contracture which prohibit full weight beaing on the whole feet.

Design outcomes

Primary

Measure	Time frame
Functional Ambulation Category immediately after the end of 20 training sessions, not later than 15 weeks after enrollment Functional Ambulation Category	—

Secondary

Measure	Time frame
Time up and go test immediately after the end of 20 training sessions , not later than 15 weeks after enrollment Time up and go test,Effect modification of the treatment effect by other baseline characteristics (pre-specified exploratory) immediately after the end of 20 training sessions , not later than 15 weeks after enrollment Same group-by-covariate interaction approach as Entry 1, applied separately to age / time since onset / lesion type. Each modifier carries a pre-stated directional hypothesis	—

Measure

Time frame

Time up and go test immediately after the end of 20 training sessions , not later than 15 weeks after enrollment Time up and go test,Effect modification of the treatment effect by other baseline characteristics (pre-specified exploratory) immediately after the end of 20 training sessions , not later than 15 weeks after enrollment Same group-by-covariate interaction approach as Entry 1, applied separately to age / time since onset / lesion type. Each modifier carries a pre-stated directional hypothesis

—

Countries

Thailand

Contacts

Public Contactparit wongphaet

samrong ruam jai foundation

spine.clinic@yahoo.com0829532225

Outcome results

None listed

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