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Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome

Sponsor
Junwei Hao (Other)
Overall Status
Completed
CT.gov ID
NCT02883270
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
24
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Robot-assisted Gait Training
  • Other: conventional rehabilitation
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome : A Randomized Controlled Trial
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

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.

Device: Robot-assisted Gait Training
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:
  • LokoHelp

    		•
    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).

    Other: conventional rehabilitation
    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).

    Outcome Measures

    Primary Outcome Measures

    1. GBS disability score [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Medical University General Hospital TianJin Tianjin China 300000

    Sponsors and Collaborators

    • Junwei Hao

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Junwei Hao, Tianjin Medical University General Hospital, Tianjin Medical University General Hospital
    ClinicalTrials.gov Identifier:
    NCT02883270
    Other Study ID Numbers:
    • IRB2016-039-01
    First Posted:
    Aug 30, 2016
    Last Update Posted:
    Sep 2, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Guillain-Barre Syndrome

    Study Results

    No Results Posted as of Sep 2, 2016