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
- Conditions
- sub-acute hemiplegic stroke
- Registration Number
- TCTR20180419004
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
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
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, knee extension < -5 degree, 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, 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in efficiency of FIM-walk 4 time points: at initial, the end of 15th sessions, the end of 30th sessions, and at discharge Improvement in efficiency of FIM-walk = (5-FIM score at the baseline)/(Number of weeks to reach FIM
- Secondary Outcome Measures
Name Time Method Gait analysis by XSENS 4 time points: at initial, the end of 15th sessions, the end of 30th sessions, and at discharge Improvement of gait parameters verified by XSENS