Feasibility of the Overground Bodyweight Supporting Walking System Andago

NCT03787199 | Completed

• 1 other identifier: 2018-00412
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gait Disorders, Neurologic; Cerebral Palsy; Stroke; Traumatic Brain Injury; Child, Only; Gait Disorders in Children

Keywords

Andago; Feasibility; Pediatric Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Stride to stride variability

  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 Outcomes (2)

• Leg muscle activity

  Appointment 3 (between minute 25 and minute 55 )

• Leg joint angles

  Appointment 3 (between minute 25 and minute 55)

Other Outcomes (9)

• Bodyweight unloading [kg]

  Data are obtained during Appointment 2 (between minute 1 and minute 10)

• Number of device stops

  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]

  At the end of Appointments 1 (between minute 55-58) and the end of Appointment 2 (between minute 40-43)

Study Arms (2)

Andago

EXPERIMENTAL

Application of walking over-ground with body-weight support in the Andago

Device: Andago

Treadmill

ACTIVE COMPARATOR

Application of walking on a treadmill with body-weight support

Other: Treadmill

Interventions

Andago DEVICE

The Andago is a body-weight supporting device with which a patient can walk overground

Andago

Treadmill OTHER

Bodyweight supported treadmill walking

Treadmill

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead
• Lions Club Zürich-Witikon: collaborator
• Mäxi Foundation: collaborator

Study Sites (1)

Rehabilitation Center of the University Children's Hospital

Affoltern am Albis, Canton of Zurich, 8910, Switzerland

Location

Related Publications (1)

• van Hedel HJA, Rosselli I, Baumgartner-Ricklin S. Clinical utility of the over-ground bodyweight-supporting walking system Andago in children and youths with gait impairments. J Neuroeng Rehabil. 2021 Feb 8;18(1):29. doi: 10.1186/s12984-021-00827-1.

  PMID: 33557834 DERIVED

MeSH Terms

Conditions

Gait Disorders, Neurologic; Cerebral Palsy; Stroke; Brain Injuries, Traumatic

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study, including a comparison between Andago and treadmill walking conditions (as we include a heterogeneous group of participants concerning age (children/adolescents), diagnosis, walking ability, etc., we include in this feasibility study 20 participants - rather than the usual 10). Patients participate in 3 appointments (planned within 10 days): Appointment 1 (60 min): patient characteristics, clinical tests (Selective Control Assessment of the Lower Extremity / Manual Muscle Testing / 10 meter walk test or 10MWT); practising on treadmill and in Andago; questions to participants Appointment 2 (45 min): determine accuracy of the unloading system; practicing on treadmill and in Andago; questions to participant Appointment 3 (60-90 min): 10MWT at onset and end; measurement of stride length, leg muscle EMG and joint kinematics during walking on treadmill with bodyweight unloading and walking overground with Andago with 3 levels of bodyweight unloading

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: December 26, 2018
• Study Start: May 28, 2018
• Primary Completion: March 19, 2019
• Study Completion: March 21, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

CH (1)