NCT02268266

Brief Summary

Early verticalization and stepping with the equipment of Hocoma ERIGO during monitoring of vital parameters. The device is already CE marked and, for the purposes of the study, will be used in accordance with the intended use (after-market clinical investigation).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2010

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 1, 2010

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

4.9 years

First QC Date

July 31, 2014

Last Update Submit

November 17, 2015

Conditions

StrokeSpinal Cord Injury

Keywords

brain injury, early rehabilitation, tilt table

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse event as a measure of safety and tolerability

    Control of cardiovascular parameters at desired ranges at healthy and at patients

    Up to 8 hours

Study Arms (1)

Single-arm study

OTHER

Early mobilization of patients after stroke or spinal cord injury. Monitoring of vital parameters during mobilization of healthy subjects

Device: Erigo

Interventions

ErigoDEVICE

The control of cardiovascular parameters within suitable ranges for healthy and neurological patients using verticalization, leg mobilization and electrical stimulation

Also known as: Erigo rehabilitation bed from Hocoma AG, Switzerland.
Single-arm study

Eligibility Criteria

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

You may qualify if:

  • minimum 18 years old
  • normal response to verbal instructions
  • oxygen saturation of the blood at least 92%
  • healthy german speaking men and women
  • non-smoker
  • heartbeat 40-100
  • systolic blood pressure 120 to 220 mmHg
  • in patients: post acute phase: stroke or other neurological functional disorder

You may not qualify if:

  • severe contraction in the legs (Ashworth \>3)
  • pregnancy
  • acute pain syndrome
  • severe cardio-pulmonary disease
  • history of orthostatic dysregulation
  • thrombophlebitis
  • diabetes
  • renal disease
  • contraindication for electric stimulation (instable epilepsy, cancer, pacemaker, palliative care)
  • weight \> 120kg
  • height \> 210 cm
  • skin lesions on legs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zürcher Höhenklinik Wald

Wald, Canton of Zurich, 8636, Switzerland

Location

ETH Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

StrokeSpinal Cord InjuriesBrain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and InjuriesCraniocerebral Trauma

Study Officials

  • Robert Riener, Prof.Dr.-Ing

    Swiss Federal Institut of Technology

    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
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

July 31, 2014

First Posted

October 20, 2014

Study Start

April 1, 2010

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

CH(2)