An interventional study of Andago and Treadmill in Gait Disorders, Neurologic, Cerebral Palsy and Stroke, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-04-18.
Sponsored by University Children's Hospital, Zurich · Not applicable, Interventional, and Device feasibility
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.
The specific aims of the current project are:
To investigate these aims, the patients will be asked to participate in 3 appointments, which should be scheduled within 10 days.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 20 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University Children's Hospital, Zurich is the lead sponsor of 92 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Application of walking over-ground with body-weight support in the Andago
Device: Andago
Application of walking on a treadmill with body-weight support
Other: Treadmill
The Andago is a body-weight supporting device with which a patient can walk overground
Bodyweight supported treadmill walking
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
Time frame: Appointment 3 (between minute 25 and minute 55 )
Leg muscle activity
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
Time frame: Appointment 3 (between minute 25 and minute 55 )
Leg joint angles
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
Time frame: Appointment 3 (between minute 25 and minute 55)
Bodyweight unloading [kg]
Comparison of bodyweight unloading according to Andago device compared to actual bodyweight unloading measured with scales \[kg\]
Time frame: Data are obtained during Appointment 2 (between minute 1 and minute 10)
Number of device stops
Number of Andago device stops measured throughout the habituation periods during appointments 1 and 2
Time frame: 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]
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.
Time frame: 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]
How much fun was it training in the Andago? \[score 0=no fun at all to 10=maximal amount of fun\]
Time frame: 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 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
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)
Manual Muscle Testing (MMT)
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
Time frame: Appointment 1 between minute 1 and 5
Selective Control Assessment of the Lower Extremity (SCALE)
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)
Time frame: Appointment 1 between minute 6 and 15 minutes
Active and passive Range of Motion (ROM) of leg joints
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.
Time frame: Appointment 1 between minute 16 and 20 minutes
10 meter walk test
Children walk 14 meters; intermediate 10 meters is time stopped to calculate the walking speed
Time frame: Appointments 1 between minute 21 and 25 and Appointment 3 between minute 1 and 5 and 56 and 60
Plan to share: Undecided — We have to check with the local ethics committee whether our pseudonymized data can be shared
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University Children's Hospital, Zurich