- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02883270
Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome
September 1, 2016 updated by: Junwei Hao
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Guillain-Barré syndrome (GBS) is an acute autoimmune disease of the peripheral nervous system, which may lead to rapidly developing motor deficits, sensory deficits, autonomic dysfunction and respiratory failure.
Approximately, 20.3% of patients cannot walk unaided at 4 weeks of symptom onset and 18.0% at 6 months.
So, restoration and improvement of independent walk are one of major goals of GBS rehabilitation.
For severely affected neurological patients, gait training using conventional therapy is technically difficult due to their motor weakness and balance problems.
Robotic-assisted gait training (RAGT)is an effective alternative to treadmill therapy with partial body weight in intense gait rehabilitation after some neuropathy.
And the proven reliability and safety of RAGT suggest that it may be effective for treating non-ambulatory patients after some neuropathy.
In our study, we investigated the anti-inflammatory effects of RAGT in non-ambulatory patients of GBS.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tianjin
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TianJin, Tianjin, China, 300000
- Tianjin Medical University General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RAGT treatment group
Robotic-assisted gait training (RAGT)is an effective alternative to treadmill therapy with partial body weight in intense gait rehabilitation after some neuropathy.
The investigators use LokoHelp for training, which is provided to the feet and the patient actively controls the knee and hip joints.
The participants of RAGT treatment group receive 30 min conventional rehabilitation and 30 min robotic-assisted gait training daily for 8 weeks.
|
Robot-assisted Gait Training is an effective alternative to treadmill therapy with partial body weight in intense gait rehabilitation and provided to the feet and the patient actively controls the knee and hip joints.
Other Names:
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Placebo Comparator: controls
The participants of controls receive 60 min conventional rehabilitation daily for 8 weeks.
Interventions included physiotherapy for muscle strengthening, endurance and gait training; occupational therapy to improve activity of daily living (domestic, community tasks).
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The participants of controls receive 60 min conventional rehabilitation daily for 8 weeks.
Interventions included physiotherapy for muscle strengthening, endurance and gait training; occupational therapy to improve activity of daily living (domestic, community tasks).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GBS disability score
Time Frame: 8 weeks
|
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.
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
August 25, 2016
First Submitted That Met QC Criteria
August 29, 2016
First Posted (Estimate)
August 30, 2016
Study Record Updates
Last Update Posted (Estimate)
September 2, 2016
Last Update Submitted That Met QC Criteria
September 1, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2016-039-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Seoul National University HospitalCompletedParkinson Disease | Gait Disorders, NeurologicKorea, Republic of
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