Clinical Trial: Feasibility of the ANDAGO System in Pediatric Neurorehabilitation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Feasibility of the ANDAGO System in Pediatric Neurorehabilitation: Bridging the Gap From Treadmill-based to Over-ground Walking

Brief Summary: In this feasibility study, the researchers would like to investigate whether it is feasible to apply the ANDAGO V2.0, a new mobile robot for body-weight supported gait training (developed by Hocoma AG) to children and adolescents undergoing neurorehabilitation. The investigators will explore several outcomes and will compare some outcomes between the children and adolescents when they walk in the ANDAGO or with their regular walking aids.

Detailed Summary:

Background and Rationale:

Children with neurological diagnoses including congenital or acquired brain lesions often have impaired lower extremity function limiting the independence in daily life activities. Achieving the ability to stand and walk independently is mentioned by most children and their parents as the highest priority for the neurorehabilitation process. Robotic gait therapy can deliver high-dosage (i.e. number of practice movements) and high-intensive (i.e. number of movements per unit time) training interventions to complement conventional treatments. Nevertheless, there is a gap between treadmill-based gait training and free walking. HocomaAG (Volketswil) developed a new mobile robot for body-weight supported gait training. ANDAGO will bridge this gap while offering a safe and functional environment for patients. Now, the researchers would like to investigate whether it is feasible to apply this prototype to children and adolescents undergoing neurorehabilitation.

Objective(s):

As the device has not been applied in a pediatric rehabilitation setting yet, the researchers want to investigate:

  • Feasibility: the investigators will examine technical features as well as patient-related aspects, safety and operability of the device during static (standing) and dynamic (walking) tasks.
  • Differences in static and dynamic tasks when standing/walking in the ANDAGO or when being supervised by a therapist.
  • Investigate the handling of the ANDAGO. Patients will have time to practice with the device and Background and Rationale:

Children with neurological diagnoses inclu
Sponsor: Huub van Hedel

Current Primary Outcome:

  • ANDAGO-1: Score on the settings questionnaire [ Time Frame: up to 24 weeks ]

    The Settings questionnaire is a self-developed tool, which covers the following areas:

    • Height of suspension
    • amount of unloading left/right
    • handrails
    • size of the harness and cuffs
    • fall Limit
    • Training mode
    • Maximum velocity
    • turning offset
  • ANDAGO-2: Position in the ANDAGO device [ Time Frame: up to 24 weeks ]
    Can the patient be positioned well in the ANDAGO? If not, what are the causes? This information is collected for general positioning in the device, fitting of harness and leg "cuffs", both with and without unloading. Furthermore it is asked whether positioning is comfortable for the patient (with or without unloading) and whether there were problems in adjusting parameters like patient lift up and down, bodyweight support, unloading uni- or bilateral. Are there problems in getting the child out of the ANDAGO and did situations occur when patient or therapists needed to press the emergency button?
  • The Edinburgh Visual Gait Score [ Time Frame: up to 24 weeks ]
    The quality of gait pattern of patients will be assessed within ANDAGO and compared to the walking pattern. Video recordings will be made from the patient and scored according to the Edinburgh Visual Gait Scor

    Original Primary Outcome:

    • ANDAGO-1: Score on the settings questionnaire [ Time Frame: up to 24 weeks ]

      The Settings questionnaire is a self-developed tool, which covers the following areas:

      • Height of suspension
      • amount of unloading left/right
      • handrails
      • size of the harness and cuffs
      • fall Limit
      • Training mode
      • Maximum velocity
      • turning offset
    • ANDAGO-2: Position in the ANDAGO device [ Time Frame: up to 24 weeks ]
      Can the patient be positioned well in the ANDAGO? If not, what are the causes? This information is collected for general positioning in the device, fitting of harness and leg "cuffs", both with and without unloading. Furthermore it is asked whether positioning is comfortable for the patient (with or without unloading) and whether there were problems in adjusting parameters like patient lift up and down, bodyweight support, unloading uni- or bilateral. Are there problems in getting the child out of the ANDAGO and did situations occur when patient or therapists needed to press the emergency button?
    • The Edinburgh Visual Gait Score [ Time Frame: up to 24 weeks ]
      The quality of gait pattern of patients will be assessed within ANDAGO and compared to the walking pattern. Video recordings will be made from the patient and scored according to the Edinburgh Visual Gait Scor

      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: University Children's Hospital, Zurich

      Dates:
      Date Received: June 23, 2016
      Date Started: June 2016
      Date Completion:
      Last Updated: May 3, 2017
      Last Verified: May 2017