Robotic Gait Training VS.Conventional Rehabilitation in SCI

Spinal Cord Injury Clinical Trial

Official title:

Robotic Gait Training VS. Conventional Physical Therapy in Spinal Cord Injury Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01432990
• Other study ID #: SCIstemcell
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 10, 2011
• Last updated: July 15, 2012
• Start date: January 2013

Study information

• Verified date: July 2012
• Source: Prasat Neurological Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

Until now, there's still no any strong evidence supported "which is the best way to restoration walking ability" in spinal cord injury. Most of the evidence suggest that, there is somehow better after gait rehabilitation for ASIA classification C and D but not improved walking ability for ASIA classification A and B. There is an RCT showed the evidence of repetitive locomotor training and physiotherapy could be improved walking and basic activities of daily living after stroke, these might be also really effect in SCI patients.

Description:

This study aim to study the effectiveness of conventional rehabilitation compare with robotic gait training machine in subacute SCI patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Subacute spinal cord injury ( C5-T12 level) patients.

• ASIA classification C and D.

• No previous joint contracture.

• No severely active medical condition.

• Can easily communicate with no obvious cognitive impairment.

• Given signed inform consent.

Exclusion Criteria:

• Previous injury or other neurological condition that related to neurodeficit in key muscles.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Robot gait training
Robotic gait training for 20 minute include preparing and rest time for 10 minute plus conventional physical therapy program for 30 minute, totally 60 minute per day for 5 working day per week.

Other:
• control
Conventional physical therapy program for 60 minute per day for 5 working day per week.

Locations

Country	Name	City	State
Thailand	Ratanapat Chanubol	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Prasat Neurological Institute	Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoölig G, Koch R, Hesse S. Repetitive locomotor training and physiotherapy improve walking and basic activities of daily living after stroke: a single-blind, randomized multicentre trial — View Citation

Schwartz I, Sajina A, Neeb M, Fisher I, Katz-Luerer M, Meiner Z. Locomotor training using a robotic device in patients with subacute spinal cord injury. Spinal Cord. 2011 Oct;49(10):1062-7. doi: 10.1038/sc.2011.59. Epub 2011 May 31. — View Citation

Taylor-Schroeder S, LaBarbera J, McDowell S, Zanca JM, Natale A, Mumma S, Gassaway J, Backus D. The SCIRehab project: treatment time spent in SCI rehabilitation. Physical therapy treatment time during inpatient spinal cord injury rehabilitation. J Spinal — View Citation

Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabilitation robotics for walking training in neurological disorders: a review. J Rehabil Res Dev. 2011;48(4):387-416. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wernig scale	Walking ability classification in spinal cord injury patients.	4 weeks.	No
Primary	Barthel index	Measure activity of daily living	4 weeks.	No
Secondary	Repas	Spasticity measurement	4 weeks.	No
Secondary	Manual muscle testing	Measure muscle power in each key muscle according to ASIA classification.	4 weeks	No
Secondary	10 meter walking test	If patients can walk, measure speed of walking with step length.	4 weeks.	No
Secondary	6 minute walking test	If patient can walk, measure endurance.	4 weeks	No