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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002104
Enrollment
46
Registered
2016-10-14
Start date
2016-07-11
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : - control group : conventional physical therapy+ additional conventional physical therapy(1 hours a day, 5days per weeks, totally 4weeks) - experimental group : conventional phys

Sponsors

Chonbuk National University Hospital
Lead Sponsor
Pusan National University Yangsan Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Berg balance scale

Secondary

MeasureTime frame
Timed Up and Go test;Fugl-Meyer Assessment (L/E) ;Functional Ambulation Category;Korean Version of Modified Barthel Index(K-MBI)

Countries

Korea, Republic of

Contacts

Public ContactLEE YEON

Chonbuk National University Hospital

sylee@mdctc.or.kr+82-63-259-3459

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026