Evaluating the efficacy and safety as a rehabilitation device intended for patients with hemiplegia due to stroke Trunk Stability Robot Balance Trainer(3DBT-33, 3 Dimensional Balance Trainer-33): prospective, multicenter, randomized, open-lable, Controlled Clinical Trial
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002104
- Lead Sponsor
- Chonbuk National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
1) Male and female aged over 20 years old
2) The patient has subscribed the informed consent
3) Patients with no communicative problem
4) Patients with hemiplegic stroke
5) More than 3 months after stroke
6) Berg balance scale of patients is 40 scores less than 21 scores
7) Patients who perform all the normal activities of daily living before the stroke
8) There is no musculoskeletal system, neurologic and cardiovascular disease
1) Participating in other clinical trials or other parties who have participated in clinical trials to be registered within one month of this clinical trial
2) Patients with a severe problem in the cognitive and visual function
3) Patients with lower-extremity musculoskeletal abnormality or damage
4) Neurologic diseases other than stroke
5) The patients with lower extremity anesthesia
6) Patients with other diseases that may affect the ability to balance
7) Posterior circulation stroke patients
8) Principal investigator who is deemed unsuitable for clinical trial participation
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Berg balance scale
- Secondary Outcome Measures
Name Time Method Timed Up and Go test;Fugl-Meyer Assessment (L/E) ;Functional Ambulation Category;Korean Version of Modified Barthel Index(K-MBI)