GBS Clinical Trial
Official title:
Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome : A Randomized Controlled Trial
This study investigates the effects of Robotic-assisted gait training in non-ambulatory patients after Guillain-Barré syndrome.The participants are randomly divided into two groups.Patients of the treatment group receive robotic-assisted gait training,while the contorls receive conventional rehabilitation.
Status | Completed |
Enrollment | 24 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of GBS; - Age between 18 and 65 years; - Period of GBS is between 4 and 8 weeks; - severe walking disabilities, defined as a GBS disability score of 2-4; Exclusion Criteria: - An unstable phase of disease; - Disorders preventing RAGT(eg, unstable cardiovascular, respiratory disease ,orthopedic, or neurological condition, unhealed decubitus, orthostatic hypotension etc.) ; - Severe cognitive impairment preventing meaningful communication; - Body weight more than 100 kg; - Pregnancy; |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Tianjin Medical University General Hospital | TianJin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Junwei Hao |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GBS disability score | 0:A healthy state.1:Minor symptoms and capable of running.2:Able to walk 10 m or more without assistance but unable to run.3:Able to walk 10 m across an open space with help.4:Bedridden or chairbound.5:Requiring assisted ventilation for at least part of the day.6:Dead. | 8 weeks | Yes |
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