Feasibility of the ANDAGO System in Pediatric Neurorehabilitation

NCT02814513 | Completed

• 1 other identifier: ANDAGO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Motor Disorders; Orthopedic Disorders

Keywords

Children; Adolescents

Outcome Measures

Primary Outcomes (6)

• ANDAGO-1: Score on the settings questionnaire

  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

  up to 24 weeks

• ANDAGO-2: Position in the ANDAGO device

  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?

  up to 24 weeks

• The Edinburgh Visual Gait Score

  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 Score, which proved one of the most valid and reliable assessments to quantify the quality of the walking pattern. The Edinburgh Visual Gait Score is the sum of the 17 items.

  up to 24 weeks

• ANDAGO-3: Accuracy of bodyweight support

  The ANDAGO might also be used as a safety system enabling patients to train their standing balance. The researchers will instruct patients to shift their weight as far as possible from the right to the left leg and from anterior to posterior, 5 times in the ANDAGO and 5 times under supervision of a therapist. The investigators will document changes in center of pressure parameters (medio-lateral and anterior-posterior direction), subjective feeling of safety (ordinal smiley scale 1-5), number of "falls" and whether the task could actually be performed or not. Furthermore they report whether the ANDAGO might have limited the exercise and whether the therapist had to intervene during the exercise.

  up to 24 weeks

• ANDAGO-4: Dynamic obstacle task

  Patients will walk in the ANDAGO or with their regular walking aids and perform an obstacle course. Please note, the steps, obstacles etc. are so narrow that the participant in the ANDAGO can step on them, over them, etc., but the ANDAGO can remain on the flat floor. Participants have to step on a higher surface, a ramp, an uneven surface and over an obstacle. The researchers will assess the time to perform the task, the number of "falls" (patients are secured), subjective feeling of safely (smileys ordinal scale 1-5) and whether the task could be accomplished. Furthermore, they assess whether collisions occurred, whether the ANDAGO limited tasks or whether the therapists needed to intervene.

  up to 24 weeks

• ANDAGO-5: Dynamic precision task

  Participants will walk 10 meters straightforward, walk a right and left turn and turn around their axis, with and without the ANDAGO. Measures are the time needed to perform these tasks, the number of "falls", the number of steps, precision and smoothness (only with ANDAGO), subjective feeling of safety and whether the task could be accomplished or not. Furthermore, the researchers assess whether collisions occurred, whether the ANDAGO limited tasks or whether the therapists needed to intervene.

  up to 24 weeks

Study Arms (1)

ANDAGO

EXPERIMENTAL

ANDAGO

Device: ANDAGO

Interventions

ANDAGO DEVICE

Feasibility: the researchers will examine technical features as well as patient-related aspects, safety and operability of the device during static (standing) and dynamic (walking) tasks.

Also known as: ANDAGO-1

ANDAGO

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \>1.35 meter
• Neurological diagnosis
• Orthopaedic diagnosis

You may not qualify if:

• Surgery or Botox injection of leg muscles during the last 3 months
• Bone fragility (e.g. non-consolidated fractures or osteotomies including craniotomies, osteopenia, osteoporosis or symptoms or indices in the patient history that infer a higher risk of bone density reduction)
• Unstable arthroplasty
• Uncontrolled knee or ankle instability that would still pose a danger despite the BWS (especially lateral instability)
• Lack of head control
• Joint contractures
• Skin lesions (including pressure sores) in areas of contact with harness support or lower extremity loading (feet)
• Sensory impairment in the lower limbs and trunk, especially with reduced pain sensation
• Risk of autonomic dysreflexia (level at or above T6; history of autonomic dysreflexia increases the risk of having a reoccurring episode)
• Recent history or elevated risk of seizures
• Cardiac conditions, e.g. cardiac insufficiency and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, vascular disorders of the lower limbs
• Cognitive deficits limiting communication
• Uncooperative or (self-)aggressive behaviour (e.g. transitory psychotic syndrome)
• Mechanical ventilation
• Long-term infusions (e.g. baclofen pump, Sacral Anterior Root Stimulation (SARS), intrathecal pumps…)

Sponsors & Collaborators

• Huub van Hedel: lead

Study Sites (1)

Rehabilitation Center for Children and Adolescents of the University Children's Hospital Zurich

Affoltern am Albis, 8910, Switzerland

Location

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Hubertus JA van Hedel, PT, PhD

  Rehabilitation Center for Children and Adolescents, University Children's Hospital Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr.

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 27, 2016
• Study Start: June 1, 2016
• Primary Completion: September 27, 2016
• Study Completion: September 27, 2016
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

CH (1)