Locomotor Training With Exoskeleton EKSO-GT in Patients With Incomplete Motor Spinal Cord Injury in a Hospital Setting

NCT02600013 | Completed

• 1 other identifier: CE-15093
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational, non-controlled, non-profit study is to describe the responses to rehabilitative training with the robotic exoskeleton EKSO-GT in patients with incomplete motor Spinal Cord Injury (AIS C or D). Such rehabilitative tool is employed during inpatient intensive rehabilitation in a 3rd level Italian hospital. Safety and tolerability of the device are also assessed and described.

Conditions

Spinal Cord Injuries

Keywords

incomplete motor SCI; robotic gait training; exoskeleton; rehabilitation tool; EKSO-GT

Outcome Measures

Primary Outcomes (4)

• Change in 10-Meter walk test with EKSO worn

  baseline (session 3, up to 1 week), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)

• Change in 6-Minutes walk test with EKSO worn

  baseline (session 3, up to 1 week), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)

• Change in 10-Meter walk test with EKSO not worn (if able)

  Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)

• Change in 6-Minutes walk test with EKSO not worn (if able)

  Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks)

Secondary Outcomes (26)

• Change in 10-Meter walk test

  Follow-up: 45 days after EKSO training closing session 12 or 18

• Change in 6-Minutes walk test

  Follow-up: 45 days after EKSO training closing session (12 or 18)

• Change in score of the Walking Index for Spinal Cord Injury, version II (WISCI-II)

  Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session

• Change in score of the Mobility part of the Spinal Cord Independence Measure scale, version III (SCIM III)

  Baseline (initial visit), session 12 (up to 6 weeks), session 18 if any (up to 9 weeks), 45 days after EKSO training closing session

• Change in number of footsteps made when EKSO is worn and actual locomotion is in place

  Immediately after the end of each rehabilitative session

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Incomplete motor SCI patients in a setting of inpatient intensive rehabilitation (3rd level hospital)

You may qualify if:

• inpatient consecutive SCI subjects;
• incomplete motor SCI of any etiology, classified as AIS C or D;
• ability to rest the upper limbs on a mobile support (e.g. walker);
• orthostatic exercise well tolerated for at least 60 continuously minutes and regularly exercised; or regular locomotor exercise; or ability of functional walk;
• sufficient range of motion (ROM) of lower limbs joints to achieve a mutual path pattern and allow transition from sitting to vertical position;
• height: minimum 157 cm, maximum 188 cm;
• maximum weight: 100 kg;
• intertrochanteric maximum distance: 46 cm;
• stable medical condition;
• intact cognitive abilities and full cooperation of the subject;
• research informed consent signed.

You may not qualify if:

• skin lesions in areas of EKSO contact;
• instability or major deformity of the spine;
• limbs joint instability;
• indication to the use of spinal orthoses;
• presence of uncontrolled spasticity (score \> 3 of the Modified Ashworth Scale) in most of the muscle groups of the lower limbs;
• active acute deep vein thrombosis;
• uncontrolled, severe and recurrent autonomic dysreflexia;
• significant bone fragility;
• recent traumatic and/or pathological bone fractures, significant for the required training;
• limb-length discrepancy for femur length (\> 1.3 cm) and leg length (\> 1.9 cm);
• neurogenic paraosteoarthropathy (at onset or inflammatory);
• symptomatic orthostatic hypotension;
• cardiopulmonary comorbidities limiting exertion;
• documented psychiatric condition that might hinder the training with EKSO-GT;
• active pregnancy.

Sponsors & Collaborators

• Montecatone Rehabilitation Institute S.p.A.: lead

Study Sites (1)

Montecatone Rehabilitation Institute S.p.A.

Imola, BO, 40026, Italy

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jacopo Bonavita, Dir Spinal U

  Montecatone Rehabilitation Institute S.p.A.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 9, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: May 25, 2018

Record last verified: 2018-05

Locations

IT (1)