TCTR20180419004
Completed
Phase 4
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
/A0 sites26 target enrollmentApril 19, 2018
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- sub-
- Sponsor
- /A
- Enrollment
- 26
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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:
- •â€¢Within 90 days after onset
- •â€¢Aged 20\-79 years
- •â€¢Body weight is between 40\-80 kg.
- •â€¢Functional Independence Measure (FIM) walking score ≤ 3
- •â€¢Brunnstrom stage of lower extremity ≤ 3
- •â€¢Able to understand the meaning of the study and follow the instruction
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, 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
Outcomes
Primary Outcomes
Not specified
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