Back to resultsComparison of an Exoskeleten With an End-effector for Assisted Gait Training in Spinal Cord Injury
Primary Purpose
Spinal Cord Injuries
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
robot assisted gait training
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries
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
Sites / Locations
- Aylin SariRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
exoskeleton
end-effector
conventional physiotherapy
Arm Description
We will use exoskeleton type robot assisted gait training for spinal cord injury rehabilitation
We will use end-effector type robot assisted gait training for spinal cord injury rehabilitation
Outcomes
Primary Outcome Measures
FAC
functional ambulational classification scale
6MWT
6 minute walking test
10MWT
10 meter walking test
Secondary Outcome Measures
ASIA
ASIA impairment scale
SCIM
Spinal cord independence measure
Full Information
NCT ID
NCT03544398
First Posted
May 22, 2018
Last Updated
May 14, 2020
Sponsor
Erenköy Physical Therapy and Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03544398
Brief Title
Comparison of an Exoskeleten With an End-effector for Assisted Gait Training in Spinal Cord Injury
Official Title
Comparison of Exoskeleten Assisted Gait Training With End-effector Assisted Gait Training in Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 15, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erenköy Physical Therapy and Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exoskeleton
Arm Type
Active Comparator
Arm Description
We will use exoskeleton type robot assisted gait training for spinal cord injury rehabilitation
Arm Title
end-effector
Arm Type
Active Comparator
Arm Description
We will use end-effector type robot assisted gait training for spinal cord injury rehabilitation
Arm Title
conventional physiotherapy
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
robot assisted gait training
Intervention Description
we use two types of robot assisted gait training and we will compare two groups.
Primary Outcome Measure Information:
Title
FAC
Description
functional ambulational classification scale
Time Frame
Change from baseline FAC class to 6th week of therapy
Title
6MWT
Description
6 minute walking test
Time Frame
Change from baseline 6MWT class to 6th week of therapy
Title
10MWT
Description
10 meter walking test
Time Frame
Change from baseline 10MWT class to 6th week of therapy
Secondary Outcome Measure Information:
Title
ASIA
Description
ASIA impairment scale
Time Frame
Change Of ASIA scale from the beginnig to the 6th week of the therapy
Title
SCIM
Description
Spinal cord independence measure
Time Frame
Change Of SCIM from the beginnig to the 6th week of the therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AYLİN SARI
Phone
05058396368
Email
mdaylinsari@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
unsal SARI
Organizational Affiliation
Dr.
Official's Role
Study Chair
Facility Information:
Facility Name
Aylin Sari
City
Istanbul
State/Province
In The USA Or Canada, Please Select...
ZIP/Postal Code
3440
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AYLİN SARI
Phone
05058396368
Email
mdaylinsari@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of an Exoskeleten With an End-effector for Assisted Gait Training in Spinal Cord Injury
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