Comparison of an Exoskeleten With an End-effector for Assisted Gait Training in Spinal Cord Injury
Comparison of Exoskeleten Assisted Gait Training With End-effector Assisted Gait Training in Spinal Cord Injury
1 other identifier
interventional
20
1 country
1
Brief Summary
Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 1, 2018
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMay 18, 2020
May 1, 2020
6 months
May 22, 2018
May 14, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
ASIA
Change Of ASIA scale from the beginnig to the 6th week of the therapy
SCIM
Change Of SCIM from the beginnig to the 6th week of the therapy
Study Arms (3)
exoskeleton
ACTIVE COMPARATORWe will use exoskeleton type robot assisted gait training for spinal cord injury rehabilitation
end-effector
ACTIVE COMPARATORWe will use end-effector type robot assisted gait training for spinal cord injury rehabilitation
conventional physiotherapy
PLACEBO COMPARATORInterventions
we use two types of robot assisted gait training and we will compare two groups.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of spinal cord injury Applying to the hospital for a rehabilitation program
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aylin Sari
Istanbul, In the USA Or Canada, Please Select..., 3440, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
unsal SARI
Dr.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 1, 2018
Study Start
January 1, 2020
Primary Completion
June 15, 2020
Study Completion
June 30, 2020
Last Updated
May 18, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share