The Comparison of Effect of Robotic-Assisted Locomotor Training and Conventional Gait Training on Movement Pattern of Hip and Knee Joints in Sagittal Plane in Subjects with Chronic Incomplete Spinal Cord Iinjury
The purpose of this study was the effect of robotic assissted gait therpay on kinematic gait parameters in Spinal cord injuries (16-55yrs). This was a Randomized Controlled Trial (RCT) study, that carried out on16 patients with chronic incompelete SCI. The volunteers were assigned in two control and experimental (robot therpay) groups after the initial assessment. kinematic gait parameters were evaluated by lokomoat system and FAM questionneare, WISCI II and ASIA were evaluated before and after interventions in both groups. The intervention sessions were designed in 3 days a week and will lasts 7 weeks. The period of treatment intervention was 30 minutes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206071722N5
Registration date:2013-08-18, 1392/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-18, 1392/05/27
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study was supported by a grant from the postgraduate Studies and Research Program, Tehran University of Medical Sciences.
Expected recruitment start date
2010-10-12, 1389/07/20
Expected recruitment end date
2011-08-21, 1390/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Effect of Robotic-Assisted Locomotor Training and Conventional Gait Training on Movement Pattern of Hip and Knee Joints in Sagittal Plane in Subjects with Chronic Incomplete Spinal Cord Iinjury
Public title
Effect of Robotic-Assisted Locomotor Training and Conventional Gait Training on Movement Pattern of Hip and Knee Joints in Subjects with Chronic Incomplete Spinal Cord Iinjury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients with traumatic motor incomplete SCI with a neurologic lesion level of L1 or higher with at least one year after lesion; No Dependency on ventilator; Not currently enrolled in physical therapy or other training regimens; Male or Female between 16-55 yrs. old ;No clinically significant sign, impairment or disease including: cardiovascular disease, respiratory disease, orthostatic hypotension, bladder and kidney disease, unhealed decubiti, pressure sore or bed sore, fracture and contracture. Decreased level of consciousness for more than 24 hours after trauma; No history of truamatic barin injury, contracture, hetropic ossification, osteoporosis, osteoarthritis; Score of Modefied Ashworth Scale in lower limb was 3 or less; Completing informed consent; Lokomat group were within the physical size of the Lokomat (ie, greater trochanter to lateral epicondyle 35 cm- 47 cm; pelvis width 50 cm, thigh circumference measured 14 cm above the knee axis 57 cm, and body weight 150 kg)
Exclusion criteria: Any reaso that interfere with the continuation of treatment or withdrawal by patient ;No complete sessions of treatment in the current study
Age
From 16 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Tehran University of Medical Sciences
Street address
6th floor, Central Building, Qods Street, Keshawarz Blv.
City
Tehran
Postal code
1449614535
Approval date
2012-11-07, 1391/08/17
Ethics committee reference number
د/92/130/1917
Health conditions studied
1
Description of health condition studied
Paraplegia and tetraplegia
ICD-10 code
G82.1
ICD-10 code description
congenital cerebral palsy
Primary outcomes
1
Description
Spasticity
Timepoint
before and after intervention
Method of measurement
Ashworth Scale
2
Description
American Spinal Injury Association(ASIA)
Timepoint
before and after intervention
Method of measurement
ASIA Form
3
Description
function
Timepoint
before and after intervention
Method of measurement
WISCI II, FAM Questionneare
4
Description
Cadence
Timepoint
before and after intervention
Method of measurement
observation
5
Description
Speed of walking
Timepoint
before and after intervention
Method of measurement
treadmill
6
Description
kinematic gait parameters
Timepoint
before and after intervention
Method of measurement
Lokomat system
Secondary outcomes
empty
Intervention groups
1
Description
Subjects in control group were treated by routine physical therapy. Conventional physical therapy consisted of Functional Electrical Stimulation (FES), weight bearing and overgound walking(Harness etal 2008).
Category
Rehabilitation
2
Description
Patients in case group were trained by Lokomat for 30 min.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Brain and Spinal cord Injury Reseach Center (BASIR), Emam Khomeini Hospital
Full name of responsible person
Fatemeh Ghiasi
Street address
Emam Khomeini Hospital Complex, Keshavarz Blv
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of edical Sciences
Full name of responsible person
Vice chancellor for educational affairs, Tehran University of Medical Sciences
Street address
The Seventh Floor- Main Building Tehran University of Medical Sciences-Ghods Str-Keshavarz Boulevard
City
Tehran
Grant name
دانشگاه علوم پزشکی تهران
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of edical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rehabilitation faculty, Tehran University of Medical Sciences