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Effect of the Robotic-assisted Gait Training Device (Welwalk®) plus physiotherapy in improving the ambulatory function in sub-acute hemiplegic stroke patients: investigator- blinded, randomized controlled trial

Effect of the Robotic-assisted Gait Training Device (Welwalk®) plus physiotherapy in improving the ambulatory function in sub-acute hemiplegic stroke patients: investigator- blinded, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180419004
Enrollment
Unknown
Registered
2018-04-19
Start date
2018-06-25
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

sub&#45

Interventions

The intervention group will receive 30 sessions of assigned treatment protocol five days/week for six weeks. The intervention group will treatment using robotic&#45
assisted gait training device (Welwalk®) for 40 min/day the level of robot assistance will be set as low as possible&#44
as long as the gait pattern does not deteriorate excessively. Besides&#44
they will receive traditional level&#45
walk training 20 minutes and other rehabilitation training for 60 minutes/day. The necessity of using feedback and the type of feedback are determined by experienced physiotherapist in charge. There a
Experimental Device,No Intervention Other
Intervention group,Control group

Sponsors

N/A,N/A
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 79 Years

Inclusion criteria

Inclusion criteria: 1. Patients or family gave written informed consents to participant in this study 2. Patients with first episode hemiplegia caused by primary supratentorial intracerebral hemorrhage or cerebral infarction 3. Patient meet the following criteria at the initial assessment: • Within 90 days after onset • Aged 20-79 years • Body weight is between 40-80 kg. • Functional Independence Measure (FIM) walking score ≤ 3 • Brunnstrom stage of lower extremity ≤ 3 • Able to understand the meaning of the study and follow the instruction

Exclusion criteria

Exclusion criteria: 1. History of myocardial infarction 2. Symptom of angina / arrhythmia 3. Symptom of respiratory disorders 4. Muscular or other neurological disorders such as diabetic neuropathy 5. Communicable infection 6. Joint contracture / limb deformity that affects walking: range of motion of hip < 5 degree&#44; knee extension < &#45;5 degree&#44; ankle dorsiflexion with knee extension position < 5 degree 7. Heterotropic ossification that restrict the range of motion of joints of lower extremities 8. Being vulnerable to fracture such as severe osteoporosis of spine&#44; lower extremities 9. Incontinence of urine or feces 10. Poor control of hypertension: BP ≥ 180/120 mmHg 11. Inadequate control of tachycardia: HR ≥ 120 bpm 12. Training restriction due to reduce cardiac function or respiratory dysfunction 13. Visual or auditory impairment hindering training 14. Pregnant patient 15. Recent participation in other clinical trials

Design outcomes

Primary

MeasureTime frame
Improvement in efficiency of FIM&#45;walk 4 time points: at initial&#44; the end of 15th sessions&#44; the end of 30th sessions&#44; and at discharge Improvement in efficiency of FIM&#45;walk = (5&#45;FIM score at the baseline)/(Number of weeks to reach FIM

Secondary

MeasureTime frame
Gait analysis by XSENS 4 time points: at initial&#44; the end of 15th sessions&#44; the end of 30th sessions&#44; and at discharge Improvement of gait parameters verified by XSENS

Countries

Thailand

Contacts

Public ContactKrisna Piravej

Chulalongkorn University

kppmrchula@gmail.com02-2564433

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026