NCT02065830

Brief Summary

The aim of this study will be to evaluate the safety and the efficacy of a new robotic exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other neurological disease with an impairment of lower limbs.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

February 12, 2014

Last Update Submit

September 9, 2022

Conditions

Spinal Cord Injury

Keywords

RobotSpinal Cord InjuryGaitQuality of lifeRehabilitationLower Limb

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Gait Spatiotemporal and Kinematic parameters at 6 months.

    Change in score between 0 and 24 weeks. 3D Gait Analysis will be collected at baseline (inclusion) (T0) after 30/40 robot session an expected average of 8 weeks (T1) and at the follow-up examination after 6 months from the training conclusion (T2).

    Ekso training at 0 and 8 weeks, and 24-week follow-up.

Secondary Outcomes (4)

  • Participant Satisfaction Questionnaire.

    Ekso training at 0 and 8 weeks, and 24-week follow-up

  • Change in blood pressure and heart rate during the training.

    Ekso training at 0 and 8 weeks, and 24-week follow-up.

  • 6 minutes walking test.

    Ekso training at 0 and 8 weeks, and 24-week follow-up.

  • Timed Up and Go test.

    Ekso training at 0 and 8 weeks, and 24-week follow-up.

Study Arms (1)

Robot Safety and Efficacy

EXPERIMENTAL

The subjects will undergo inpatient rehabilitation consisting of a treatment cycle of 30/40 training section using the robot EKSO system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45/60 min and balance training.

Device: EKSO

Interventions

EKSODEVICE

The subjects will undergo inpatient rehabilitation consisting of a treatment cycle of 30/40 training section using the robot EKSO system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45/60 min and balance training.

Robot Safety and Efficacy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic motor complete or incomplete cervical and thoracic (C7-T12) spinal cord injury.
  • Skin integrity.
  • Adequate hip, knee and ankle range of motion.
  • Spasticity level of 3 or less (Ashworth scale).

You may not qualify if:

  • Cardiological or respiratory comorbidity.
  • Hemodynamic instability.
  • Presence of unhealed fractures.
  • Presence of heterotopic ossification that may impede walking.
  • Presence of osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione Centri di Riabilitazione Padre Pio Onlus

San Giovanni Rotondo, Foggia, Italy

Location

IRCCS San Raffaele Pisana Roma

Roma, 00161, Italy

Location

Related Publications (1)

  • Sale P, Russo EF, Russo M, Masiero S, Piccione F, Calabro RS, Filoni S. Effects on mobility training and de-adaptations in subjects with Spinal Cord Injury due to a Wearable Robot: a preliminary report. BMC Neurol. 2016 Jan 28;16:12. doi: 10.1186/s12883-016-0536-0.

    PMID: 26818847DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Patrizio Sale, MD

    IRCCS San Raffaele Pisana Roma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 19, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

IT(2)