Clinical trial NCT01432990: Robotic Gait Training VS.Conventional Rehabilitation in SCI
Official title: Robotic Gait Training VS. Conventional Physical Therapy in Spinal Cord Injury Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Spinal Cord Injury
Keywords: SCI
gait
rehabilitation
robotic
Lead sponsor: Prasat Neurological Institute
Sponsor class: OTHER_GOV
Collaborators: name: Mahidol University
First posted: 2011-09-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Wernig scale
timeFrame: 4 weeks.
measure: Barthel index
timeFrame: 4 weeks.
Secondary outcomes:
measure: Repas
timeFrame: 4 weeks.
measure: Manual muscle testing
timeFrame: 4 weeks
measure: 10 meter walking test
timeFrame: 4 weeks.
measure: 6 minute walking test
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ratanapat Chanubol
Study officials:
affiliation: PM&R department, Prasat Neurological Institute, Bangkok, Thailand. 10400
name: Ratanapat Chanubol, MD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Pohl M, Werner C, Holzgraefe M, Kroczek G, Mehrholz J, Wingendorf I, Hoolig 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 (DEutsche GAngtrainerStudie, DEGAS). Clin Rehabil. 2007 Jan;21(1):17-27. doi: 10.1177/0269215506071281.
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. doi: 10.1682/jrrd.2010.04.0055.
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 Cord Med. 2011;34(2):149-61. doi: 10.1179/107902611X12971826988057.