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

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ClinicalTrials.gov Identifier: NCT03544398
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Erenköy Physical Therapy and Rehabilitation Hospital

Brief Summary:
We aimed to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation

Condition or disease Intervention/treatment
Spinal Cord Injuries Other: robot assisted gait training

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. 30 patients who treated with exoskeleton(Robogait) and 30 patients who treated with end-effector(Lokohelp) will be included in the study. 5 days a week besides conventional treatment methods 3 days a week for 4 weeks patients who received robotic treatment for 45 minutes a day will be evaluated at the start and end of the treatment.

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Comparison of Exoskeleten Assisted Gait Training With End-effector Assisted Gait Training in Spinal Cord Injury
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. FAC [ Time Frame: 3 minutes ]
    functional ambulational classification scale


Secondary Outcome Measures :
  1. ASIA [ Time Frame: 15 minutes ]
    ASIA impairment scale



Information from the National Library of Medicine

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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
Sampling Method:   Probability Sample
Study Population
Between the ages of 18-80 patients with spinal cord injury who were admitted to the robotic rehabilitation prograM
Criteria

Inclusion Criteria:

Between the ages of 18-80 Patients with spinal cord injury who were admitted to the robotic 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 Patients with long-term infusion therapy Hip, knee, ankle arthrodesis Epilepsy Patients with disproportionate limb or vertebrae, such as bone cartilage dysplasia


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
Contact: AYLİN SARI 05058396368 mdaylinsari@gmail.com

Locations
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
Study Chair: unsal SARI Dr.

Responsible Party: Erenköy Physical Therapy and Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03544398     History of Changes
Other Study ID Numbers: Erenkoy
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System