Comparison of an Exoskeleten With an End-effector for Assisted Gait Training in Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation

Detailed Description
-----------------
It was planned to evaluate patients aged between 18 and 80 years who will admit to the robotic rehabilitation program due to spinal cord injury. Patients will divide into three groups as Exoskeleton, End-effector and conventional therapy. Exoskeleton and End-effector group will receive robotic therapy 4 days a week besides conventional treatment for 6 weeks. All groups will be evaluated at the start and end of the treatment.

Official Title
-----------------
Comparison of Exoskeleten Assisted Gait Training With End-effector Assisted Gait Training in Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injuries

Intervention / Treatment
-----------------
* Other: robot assisted gait training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of spinal cord injury Applying to the hospital for a rehabilitation program Exclusion Criteria: Inadequate body weight (obesity) Severe contractures Bone instability ( nonstable spinal cord fracture, and severe osteoporosis) Circulation problems Cardiac nonconformity Open wounds on the lower extremities or in the body where they will come into contact with the orthosis Uncoordinated, psychotic or aggressive patients Serious cognitive disorders Long-term infusion therapy Hip, knee, ankle arthrodesis Epilepsy Disproportionate limb or vertebrae, such as bone cartilage dysplasia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: exoskeleton<br>We will use exoskeleton type robot assisted gait training for spinal cord injury rehabilitation | Other: robot assisted gait training<br>* we use two types of robot assisted gait training and we will compare two groups.<br>|
| Active Comparator: end-effector<br>We will use end-effector type robot assisted gait training for spinal cord injury rehabilitation | Other: robot assisted gait training<br>* we use two types of robot assisted gait training and we will compare two groups.<br>|
| Placebo Comparator: conventional physiotherapy<br> | Other: robot assisted gait training<br>* we use two types of robot assisted gait training and we will compare two groups.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAC | functional ambulational classification scale | Change from baseline FAC class to 6th week of therapy | 
| 6MWT | 6 minute walking test | Change from baseline 6MWT class to 6th week of therapy | 
| 10MWT | 10 meter walking test | Change from baseline 10MWT class to 6th week of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASIA | ASIA impairment scale | Change Of ASIA scale from the beginnig to the 6th week of the therapy | 
| SCIM | Spinal cord independence measure | Change Of SCIM from the beginnig to the 6th week of the therapy |