Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lions Club Zürich-Witikon | UNKNOWN |
| Mäxi Foundation | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Andago | Experimental | Application of walking over-ground with body-weight support in the Andago |
|
| Treadmill | Active Comparator | Application of walking on a treadmill with body-weight support |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Andago | Device | The Andago is a body-weight supporting device with which a patient can walk overground |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Appointment 3 (between minute 25 and minute 55 ) |
| Measure | Description | Time Frame |
|---|---|---|
| Bodyweight unloading [kg] | Comparison of bodyweight unloading according to Andago device compared to actual bodyweight unloading measured with scales [kg] | Data are obtained during Appointment 2 (between minute 1 and minute 10) |
| Number of device stops |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Center of the University Children's Hospital | Affoltern am Albis | Canton of Zurich | 8910 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33557834 | Derived | 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. |
Not provided
Not provided
We have to check with the local ethics committee whether our pseudonymized data can be shared
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| D002547 | Cerebral Palsy |
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Treadmill | Other | Bodyweight supported treadmill walking |
|
| 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 | Appointment 3 (between minute 25 and minute 55) |
Number of Andago device stops measured throughout the habituation periods during appointments 1 and 2
| 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. | 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] | 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 | 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 | 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) | 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. | 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 | Appointments 1 between minute 21 and 25 and Appointment 3 between minute 1 and 5 and 56 and 60 |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |