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

Not Applicable

Completed

• Conditions: GBS
• Interventions: Other: conventional rehabilitation; Device: Robot-assisted Gait Training

• Registration Number: NCT02883270
• Lead Sponsor: Junwei Hao

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.

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 Timeline

• Study Start: 2014-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2016-08-25
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-08-30
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls	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).
RAGT treatment group	Robot-assisted Gait Training	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 TianJin, Tianjin, China