Patients experiencing their first-ever stroke with onset in the past 3 months who has hemiparesis with a Functional Ambulation Category (FAC) score of 3 or below stroke, robotic, gait training, exoskeleton device, rehabilitation, ambulatory function, walking ability
Conditions
Interventions
Participants receive 12 session of Hybrid Assistive Limb Lower Limb Type assisted gait training in additional to conventional rehabilitation within 3-4 weeks,Participants receive 12 session of Lokomat
Experimental Device,Active Comparator Device
Hybrid Assistive Limb Lower Limb Type (HAL-ML05),Lokomat Pro
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients experiencing their first-ever stroke with symptom onset within the past 3 months. 2.Age between 18 and 75 years. 3.Hemiparesis with a Functional Ambulation Category (FAC) score of 3 or below. 4.Able to maintain independent sitting for more than 1 minute without external support. 5. Patients who meet the indications for inpatient rehabilitation admission, defined as having disability in at least 2 of the following 5 domains (mobility, self-care in basic activities of daily living, communication, swallowing, or bowel/bladder problem), and who demonstrate sufficient learning capacity and cooperation to participate in rehabilitation for more than 3 hours per day. 6.Able to understand and follow instructions. 7.Written informed consent obtained from the patient or their legal caregiver.
Exclusion criteria
Exclusion criteria: 1.Presence of a lesion involving the brainstem, cerebellum, or subarachnoid hemorrhage. 2.Patients with bilateral hemiplegia 3. Presence of other concomitant neurological disorders, such as Parkinson disease or amyotrophic lateral sclerosis. 4.Limitations to gait training due to conditions such as cognitive impairment (TMSE less than 24 points or MoCA less than 24 points), spatial neglect, hemianopia, altered consciousness, psychiatric symptoms (PHQ 9 more than 7 points), cardiac disease with NYHA class equal of level II or above, peripheral vascular disease or deep vein thrombosis of the lower extremities, or orthostatic hypotension. 5.High risk of injury or serious complications during training, including severe lower limb spasticity preventing joint movement (modified Ashworth Scale of 3 or above), lower limb joint contractures, severe osteoporosis, uncontrolled epilepsy or history of post stroke seizures with inadequate control, which may predispose to seizures during training. 6.Anthropometric characteristics unsuitable for device fitting, including body weight less than 40 kg or more than 100 kg, or lower limb amputation. 7.Dermatological conditions deemed unsuitable for robotic assisted training. 8.Inability to ambulate independently prior to the stroke event. 9.Patients receiving concurrent interventions such as non invasive brain stimulation, peripheral magnetic stimulation, or neuromuscular electrical stimulation of the lower extremities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Walking ability baseline, end of intervention, 4 weeks after the end of intervention Functional Ambulatory Categories (FAC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Motor power of lower extremities in affected side baseline, end of intervention, 4 weeks after the end of intervention Medical Research Council (MRC) Scale,walking speed baseline, end of intervention, 4 weeks after the end of intervention 10 meter walk test,walking endurance baseline, end of intervention, 4 weeks after the end of intervention 2 minute walk distance,functional balance baseline, end of intervention, 4 weeks after the end of intervention Berg balance scale (BBS),independence in activities of daily living (ADLs). baseline, end of intervention, 4 weeks after the end of intervention Barthel index ,Adverse effect end of intervention Patient reported outcome,Treatment satisfaction end of intervention Patient Satisfaction Questionaire | — |
Countries
Thailand
Contacts
Public ContactRatthapong Juntrakul
Faculty of medicine Siriraj hospital, Mahidol university
Outcome results
None listed