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

Not Applicable

• Conditions: Spinal Cord Injuries
• Interventions: Other: robot assisted gait training

• Registration Number: NCT03544398
• Lead Sponsor: Erenköy Physical Therapy and Rehabilitation Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-01
• Study Start: 2020-01-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-18
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
end-effector	robot assisted gait training	We will use end-effector type robot assisted gait training for spinal cord injury rehabilitation
exoskeleton	robot assisted gait training	We will use exoskeleton type robot assisted gait training for spinal cord injury rehabilitation
conventional physiotherapy	robot assisted gait training	-

Primary Outcome Measures

Name	Time	Method
FAC	Change from baseline FAC class to 6th week of therapy	functional ambulational classification scale
6MWT	Change from baseline 6MWT class to 6th week of therapy	6 minute walking test
10MWT	Change from baseline 10MWT class to 6th week of therapy	10 meter walking test

Secondary Outcome Measures

Name	Time	Method
SCIM	Change Of SCIM from the beginnig to the 6th week of the therapy	Spinal cord independence measure
ASIA	Change Of ASIA scale from the beginnig to the 6th week of the therapy	ASIA impairment scale

Trial Locations

Locations (1)

Aylin Sari; 🇹🇷 Istanbul, In The USA Or Canada, Please Select..., Turkey