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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544398
• Other study ID #: Erenkoy
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2020
• Source: Erenköy Physical Therapy and Rehabilitation Hospital
• Contact: AYLIN SARI
• Phone: 05058396368
• Email: mdaylinsari[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• robot assisted gait training
we use two types of robot assisted gait training and we will compare two groups.

Locations

Country	Name	City	State
Turkey	Aylin Sari	Istanbul	In The USA Or Canada, Please Select...

Sponsors (1)

Lead Sponsor	Collaborator
Erenköy Physical Therapy and Rehabilitation Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FAC	functional ambulational classification scale	Change from baseline FAC class to 6th week of therapy
Primary	6MWT	6 minute walking test	Change from baseline 6MWT class to 6th week of therapy
Primary	10MWT	10 meter walking test	Change from baseline 10MWT class to 6th week of therapy
Secondary	ASIA	ASIA impairment scale	Change Of ASIA scale from the beginnig to the 6th week of the therapy
Secondary	SCIM	Spinal cord independence measure	Change Of SCIM from the beginnig to the 6th week of the therapy