Feasibility of the Overground Bodyweight Supporting Walking System Andago

April 17, 2019 updated by: University Children's Hospital, Zurich
The overall aim of this project is to investigate the clinical utility of the Andago System, a CE certified mobile bodyweight supporting walking robot, in children with neuromotor disorders. Clinical utility encompasses practicability, acceptability, appropriateness, and accessibility. In this study, the investigators would like to investigate several aspects of clinical utility that belong to the first three components.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The specific aims of the current project are:

  1. To investigate the practicability, the investigators plan to determine the accuracy of the weight-supporting system of the Andago and the time needed for donning and doffing. The investigators also evaluate the number of times that the device stops and the nature of these stops (due to errors, sitting of the patient, when preventing falls, or when the patient moves too fast).
  2. To evaluate acceptability, the investigators plan to evaluate differences in motivation and measures reflecting safety (i.e. number of falls prevented) and subjective feeling of safety when patients walk with the Andago compared to walking with their usual walking aids.
  3. To evaluate the appropriateness, the investigators are interested in differences between walking on a treadmill and walking overground with this device or changes that occur during walking overground when changing the level of BWS through the unloading system. Therapists should be aware of these differences to know what the advantage of such a system could be or how adjustments in settings influence the walking pattern. The investigators plan two investigations: (a) To determine differences in stride-to-stride variability, leg muscle activation, hip, knee and ankle joint kinematics and other gait parameters during walking in the Andago (overground) versus walking on a treadmill. (b) To determine differences in the same parameters when walking in the Andago with different levels of BWS. These levels are the minimal required level of BWS to walk without buckling the knees (ref BWS), ref BWS plus 15% and ref BWS plus 30%.

To investigate these aims, the patients will be asked to participate in 3 appointments, which should be scheduled within 10 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zurich
      • Affoltern Am Albis, Zurich, Switzerland, 8910
        • Rehabilitation Center of the University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Neuromotor or orthopaedic disorders
  • taller than 135 cm
  • able to understand simple instructions
  • able to walk 10 meters with or without walking aid
  • maximal age of 18 years (a minimal age is not defined as according to the growth curve, children younger than 7-8 years cannot be included because of insufficient height)
  • given informed consent.

Exclusion Criteria:

  • not consolidated fractures or bone fragility of the lower extremities
  • skin lesions in the harness' area which cannot be protected
  • unstable hip, knee and/or ankle Joints
  • reduced head control or inability to maintain an upright Position
  • inability to communicate discomfort or pain
  • surgery in the last 3 months
  • newly implanted baclofen-pump (or children highly sensitive to it)
  • implanted pacemakers
  • passive knee extension deficit > 30°
  • self-selected walking speed > 3.2 km/h.
  • weight > 135 kg
  • height > 2 m.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DEVICE_FEASIBILITY
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Andago
Application of walking over-ground with body-weight support in the Andago
Device: Andago
The Andago is a body-weight supporting device with which a patient can walk overground
ACTIVE_COMPARATOR: Treadmill
Application of walking on a treadmill with body-weight support
Other: Treadmill
Bodyweight supported treadmill walking

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stride to stride variability
Time Frame: Appointment 3 (between minute 25 and minute 55 )
Variability in stride length recorded during at least 20 steps for each of the following conditions: Andago with reference bodyweight support; Andago with 15% more bodyweight support; Andago with 30% more bodyweight support; and treadmill condition with reference bodyweight support
Appointment 3 (between minute 25 and minute 55 )

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Leg muscle activity
Time Frame: Appointment 3 (between minute 25 and minute 55 )
Amplitude of electromyographic recordings recorded during at least 20 steps for each of the following conditions: Andago with reference bodyweight support; Andago with 15% more bodyweight support; Andago with 30% more bodyweight support; and treadmill condition with reference bodyweight support
Appointment 3 (between minute 25 and minute 55 )
Leg joint angles
Time Frame: Appointment 3 (between minute 25 and minute 55)
Joint angles recorded with electrogoniometers during at least 20 steps for each of the following conditions: Andago with reference bodyweight support; Andago with 15% more bodyweight support; Andago with 30% more bodyweight support; and treadmill condition with reference bodyweight support
Appointment 3 (between minute 25 and minute 55)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bodyweight unloading [kg]
Time Frame: Data are obtained during Appointment 2 (between minute 1 and minute 10)
Comparison of bodyweight unloading according to Andago device compared to actual bodyweight unloading measured with scales [kg]
Data are obtained during Appointment 2 (between minute 1 and minute 10)
Number of device stops
Time Frame: Data are obtained during Appointment 1 between minute 25 and minute 45 and Appointment 2 between minute 10 to 30
Number of Andago device stops measured throughout the habituation periods during appointments 1 and 2
Data are obtained during Appointment 1 between minute 25 and minute 45 and Appointment 2 between minute 10 to 30
Customized questionnaire investigating acceptability [dichotomous]
Time Frame: At the end of Appointments 1 (between minute 55-58) and the end of Appointment 2 (between minute 40-43)
Participant is being asked whether the patient prefers treadmill or Andago (dichotomous outcome: 0=treadmill/1=Andago), and if the patient would like to train again in the Andago (0=no/1=yes). No sum score is calculated.
At the end of Appointments 1 (between minute 55-58) and the end of Appointment 2 (between minute 40-43)
Questionnaire acceptability [visual analogue scale]
Time Frame: At the end of Appointments 1 (between minute 59-60) and the end of Appointment 2 (between minute 44-45)
How much fun was it training in the Andago? [score 0=no fun at all to 10=maximal amount of fun]
At the end of Appointments 1 (between minute 59-60) and the end of Appointment 2 (between minute 44-45)
Time needed for donning and doffing [seconds]
Time Frame: During Appointment 1 (mounting around minute 25; taking off around minute 43) and Appointment 2 (mounting around minute 1; taking off around minute 28)
Time in seconds needed for mounting the patient in the Andago and, at the end of walking in the Andago, the time needed to get the patient out of the device
During Appointment 1 (mounting around minute 25; taking off around minute 43) and Appointment 2 (mounting around minute 1; taking off around minute 28)
Manual Muscle Testing (MMT)
Time Frame: Appointment 1 between minute 1 and 5
Manual muscle testing is performed for providing a characterization of the patients. For each muscle group, a score is given between 0 (no visible or palpable contraction) and 5 (patient moves over the full range of motion against gravity with additional maximal resistance). The following muscles will be tested: hip flexors and extensors; hip inner- and outer-rotators; knee flexors and extensors; ankle plantar and dorsal flexors
Appointment 1 between minute 1 and 5
Selective Control Assessment of the Lower Extremity (SCALE)
Time Frame: Appointment 1 between minute 6 and 15 minutes
The SCALE assesses the selectivity of lower extremity joints. It provides a score between 0 (not able) and 2 (normal selectivity) for each of the following joints: hip, knee, ankle, subtalar joint, and toes. It provides a sum score for the left and right leg separately (0= not able; 10= normal selectivity) and an overall sum score (0=not able; 20=normal selectivity)
Appointment 1 between minute 6 and 15 minutes
Active and passive Range of Motion (ROM) of leg joints
Time Frame: Appointment 1 between minute 16 and 20 minutes
Active (by patient) and passive (by therapist) mobility of the hip, knee and ankle joints are made in the sagittal plane. The ROM is noted according to the neutral zero method (degrees). ROM testing is performed for providing a characterization of the patients.
Appointment 1 between minute 16 and 20 minutes
10 meter walk test
Time Frame: Appointments 1 between minute 21 and 25 and Appointment 3 between minute 1 and 5 and 56 and 60
Children walk 14 meters; intermediate 10 meters is time stopped to calculate the walking speed
Appointments 1 between minute 21 and 25 and Appointment 3 between minute 1 and 5 and 56 and 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Children's Hospital, Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mäxi Foundation
Lions Club Zürich-Witikon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 28, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-00412

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We have to check with the local ethics committee whether our pseudonymized data can be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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