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

Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: 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. 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AYLİN SARI; Phone Number: 05058396368; Email: mdaylinsari@gmail.com

Study Locations

• Turkey
  • In The USA Or Canada, Please Select...
    • Istanbul, In The USA Or Canada, Please Select..., Turkey, 3440
      • Recruiting
      • Aylin Sari
      • Contact: AYLİN SARI; Phone Number: 05058396368; Email: mdaylinsari@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASIA	ASIA impairment scale	Change Of ASIA scale from the beginnig to the 6th week of the therapy
SCIM	Spinal cord independence measure	Change Of SCIM from the beginnig to the 6th week of the therapy

Collaborators and Investigators

• Sponsor: Erenköy Physical Therapy and Rehabilitation Hospital
• Investigators: Study Chair: unsal SARI, Dr.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): June 15, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: Erenkoy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No