Clinical trial NCT03787199: Feasibility of the Overground Bodyweight Supporting Walking System Andago
Official title: Feasibility of the Overground Bodyweight Supporting Walking System Andago
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait Disorders, Neurologic
Cerebral Palsy
Stroke
Traumatic Brain Injury
Child, Only
Gait Disorders in Children
Keywords: Andago
Feasibility
Pediatric Neurorehabilitation
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
Collaborators: name: Lions Club Zürich-Witikon
name: Mäxi Foundation
First posted: 2018-12-26
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stride to stride variability
timeFrame: Appointment 3 (between minute 25 and minute 55 )
Secondary outcomes:
measure: Leg muscle activity
timeFrame: Appointment 3 (between minute 25 and minute 55 )
measure: Leg joint angles
timeFrame: Appointment 3 (between minute 25 and minute 55)
Other outcomes:
measure: Bodyweight unloading [kg]
timeFrame: Data are obtained during Appointment 2 (between minute 1 and minute 10)
measure: Number of device stops
timeFrame: Data are obtained during Appointment 1 between minute 25 and minute 45 and Appointment 2 between minute 10 to 30
measure: Customized questionnaire investigating acceptability [dichotomous]
timeFrame: At the end of Appointments 1 (between minute 55-58) and the end of Appointment 2 (between minute 40-43)
measure: Questionnaire acceptability [visual analogue scale]
timeFrame: At the end of Appointments 1 (between minute 59-60) and the end of Appointment 2 (between minute 44-45)
measure: Time needed for donning and doffing [seconds]
timeFrame: During Appointment 1 (mounting around minute 25; taking off around minute 43) and Appointment 2 (mounting around minute 1; taking off around minute 28)
measure: Manual Muscle Testing (MMT)
timeFrame: Appointment 1 between minute 1 and 5
measure: Selective Control Assessment of the Lower Extremity (SCALE)
timeFrame: Appointment 1 between minute 6 and 15 minutes
measure: Active and passive Range of Motion (ROM) of leg joints
timeFrame: Appointment 1 between minute 16 and 20 minutes
measure: 10 meter walk test
timeFrame: Appointments 1 between minute 21 and 25 and Appointment 3 between minute 1 and 5 and 56 and 60
Locations:
city: Affoltern Am Albis
country: Switzerland
facility: Rehabilitation Center of the University Children's Hospital
state: Zurich
Study officials:
References:
citation: 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.