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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03544398
Recruitment Status : Unknown
Verified May 2020 by AYLİN SARI, Erenköy Physical Therapy and Rehabilitation Hospital.
Recruitment status was:  Recruiting
First Posted : June 1, 2018
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
AYLİN SARI, Erenköy Physical Therapy and Rehabilitation Hospital

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

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Other: robot assisted gait training Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Exoskeleten Assisted Gait Training With End-effector Assisted Gait Training in Spinal Cord Injury
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: exoskeleton
We will use exoskeleton type robot assisted gait training for spinal cord injury rehabilitation
 Other: robot assisted gait training
we use two types of robot assisted gait training and we will compare two groups.
Active Comparator: end-effector
We will use end-effector type robot assisted gait training for spinal cord injury rehabilitation
 Other: robot assisted gait training
we use two types of robot assisted gait training and we will compare two groups.
Placebo Comparator: conventional physiotherapy Other: robot assisted gait training
we use two types of robot assisted gait training and we will compare two groups.


Outcome Measures
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Primary Outcome Measures :
  1. FAC [ Time Frame: Change from baseline FAC class to 6th week of therapy ]
    functional ambulational classification scale

  2. 6MWT [ Time Frame: Change from baseline 6MWT class to 6th week of therapy ]
    6 minute walking test

  3. 10MWT [ Time Frame: Change from baseline 10MWT class to 6th week of therapy ]
    10 meter walking test


Secondary Outcome Measures :
  1. ASIA [ Time Frame: Change Of ASIA scale from the beginnig to the 6th week of the therapy ]
    ASIA impairment scale

  2. SCIM [ Time Frame: Change Of SCIM from the beginnig to the 6th week of the therapy ]
    Spinal cord independence measure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544398


Contacts
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Contact: AYLİN SARI 05058396368 mdaylinsari@gmail.com

Locations
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Turkey
Aylin Sari Recruiting
Istanbul, In The USA Or Canada, Please Select..., Turkey, 3440
Contact: AYLİN SARI    05058396368    mdaylinsari@gmail.com   
Sponsors and Collaborators
Erenköy Physical Therapy and Rehabilitation Hospital
Investigators
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Study Chair: unsal SARI Dr.
More Information
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Responsible Party: AYLİN SARI, MD, Erenköy Physical Therapy and Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03544398    
Other Study ID Numbers: Erenkoy
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System