NCT03410550

Brief Summary

The purpose of the current study is to investigate the effects of powered exoskeleton (EKSO) on cardiovascular performance as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments. The effects of exoskeleton training on walking kinematics including stand-up time, walking time, distance covered and speed of walking will also be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

January 11, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

3.5 years

First QC Date

January 11, 2018

Last Update Submit

February 1, 2022

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (4)

  • Blood Pressure (mmHg)

    Resting blood pressure and post-exercise blood pressure will be measured every visit.

    12 weeks

  • Walking time (minutes)

    The robotic unit will measure standing up time, walking time and walking distance for every visit.

    12 weeks

  • Oxygen uptake (l/min)

    Oxygen uptake will be measured during sitting, standing and walking at the beginning and at the end of the training program.

    12 weeks

  • Body Composition (kg)

    Body composition using dual energy x-ray absorptiometry anthropometrics' will be measured during sitting, standing and walking at the beginning and at the end of the training program.

    12 weeks

Secondary Outcomes (5)

  • Six minute-walk Test (meter)

    12 weeks

  • Walking Index for Spinal Cord Injury II (WISCI II)

    12 weeks

  • Electromyography (EMG) activity of 6 muscle groups (mV)

    12 weeks

  • Mitochondrial health using near infra-red spectroscopy (seconds)

    12 weeks

  • 10 meter walk Test (m/sec)

    12 weeks

Study Arms (1)

Exoskeleton Training

EXPERIMENTAL

Twenty men with complete and incomplete SCI will be enrolled in the trial.

Device: Exoskeleton Training

Interventions

Exoskeleton TrainingDEVICE

Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10).

Exoskeleton Training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A written clearance by the medical doctor .
  • Participants will have to be 1 year post-injury with any level of injury.
  • All participants will be between 18-70 years old, men/women,

You may not qualify if:

  • Participants with body weight greater than 220 lbs
  • Whole body T-scores less than -2.5 standard deviation will result in elimination from the program.
  • Hip width, upper leg length and lower leg length that do not fit in the robotic suit.
  • Previous unhealed fracture in both lower or upper extremities
  • Leg length discrepancy that is unlikely to be managed by having shoe inserts
  • High resting blood pressure greater than 130/80 mmHg
  • Sudden drop in blood pressure by 20 mmHg especially in persons with tetraplegia.
  • Medical conditions prior enrollment similar to cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin, pressures sores stage 2 or greater, or urinary tract infection or symptoms.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10) SCI.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of SCI Research

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 25, 2018

Study Start

July 1, 2018

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)