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Effects of Wearable Exoskeleton Robotic Gait Training in Subacute Stroke: A Pilot Randomized Controlled Trial

Effects of Wearable Exoskeleton Robotic Gait Training in Subacute Stroke: A Pilot Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231031005
Enrollment
20
Registered
2023-10-31
Start date
2022-09-27
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

Hemiplegic subacute stroke patient (between 2 weeks and 6 months) who are not able to walk independently stroke, wearable exoskeleton, gait rehabilitation

Interventions

This group will receive gait training using the FREE Bionics FREE Walk wearable exoskeleton (manufactured in Taiwan
Appendix 1), a robotic gait training device powered by an engine. The exoskeleton is adjustable to fit each patient and designed to be worn on the lower limbs. The exoskeleton controls the movement of
s ability, which includes stand-up, walking training, and exercises.
Wearable exoskeleton combined with conventional rehabilitation training,Conventional rehabilitation training

Sponsors

Viktas Aeternum Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patient aged 18 years or old 2.First confirmed diagnosis of stroke through radiographs 3.Hemiplegia 4.Stroke occurred between 2 weeks and 6 months 5.Functional Ambulation Categories ranging from 0 to 2 6.Capable of independently deciding to participate in the study and able to follow instructions during assessment and gait training, as well as participate in controlling the wearable exoskeleton with the physiotherapist

Exclusion criteria

Exclusion criteria: 1.Patients with unstable vital signs or neurological symptoms 2.Patients with medical diseases that may cause harm/adverse outcomes, such as uncontrolled hypertension (SBP > 180 mmHg or DBP > 100 mmHg), orthostatic hypotension, myocardial ischemia/heart failure in the last three months, respiratory disorders (such as chronic obstructive pulmonary disease and asthma), severe osteoporosis that increases the fractures risk from falling while walking and standing 3.Patients with neurological disorders, such as Parkinson disease, dementia, and multiple sclerosis 4.Patients with severe communication and cognitive impairment that prevent them from following instructions or participating in the training 5.Patients with dermatitis or open wounds on the torso or lower limb 6.Patients with lower limb length discrepancy greater than 2 cm 7.Patients with a Modified Ashworth Scale of lower limb >= 3 8.Patients with a limited range of motion in the lower limb that prevents them from changing from sitting to standing or stepping from standing with wearable exoskeleton robotic gait training

Design outcomes

Primary

MeasureTime frame
Ambulation before and after receiving gait training 10 times, 20 times, and at 1-month follow-up Functional Ambulation Category

Secondary

MeasureTime frame
Spatiotemporal gait parameters before and after receiving gait training 10 times, 20 times, and at 1-month follow-up using G-WALK device ,Mobility before and after receiving gait training 10 times, 20 times, and at 1-month follow-up Rivermead Mobility Index ,Activities of daily living before and after receiving gait training 10 times, 20 times, and at 1-month follow-up Barthel Index

Countries

Thailand

Contacts

Public ContactWasuwat Kitisomprayoonkul

Faculty of Medicine, Chulalongkorn University

wkitisom@yahoo.co.th022564000

Outcome results

None listed

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