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

GBS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883270
• Other study ID #: IRB2016-039-01
• Status: Completed
• Phase: N/A
• First received: August 25, 2016
• Last updated: September 1, 2016
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Tianjin Medical University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Tianjin Municipal Health Bureau
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• GBS
• Guillain-Barre Syndrome

Intervention

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:
• 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).

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	TianJin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Junwei Hao

Country where clinical trial is conducted

China, 

Outcome

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