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NCT Number: NCT02883270

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

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.

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Key information

Conditions

GBS

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Robot-assisted gait training

Device

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

conventional rehabilitation

Other

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).

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Junwei Hao

Other

Registry information

Official study title

Effects of Robotic-assisted Gait Training In Non-Ambulatory Patients After Guillain-Barré Syndrome : A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 30, 2016
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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