Gait Disorders, NeurologicNCT03787199
Feasibility of the Overground Bodyweight Supporting Walking System Andago
A study testing Andago and Treadmill in people with Gait Disorders, Neurologic and Cerebral Palsy, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Gait Disorders, Neurologic, Cerebral Palsy, Stroke
- What is being tested?
- Andago and Treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 May 2018to 21 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Rehabilitation Center of the University Children's Hospital
Affoltern am Albis, Canton of Zurich, 8910
About this study
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.
Read the detailed description
The specific aims of the current project are:
- 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).
- 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.
- 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.
- Conditions
- Gait Disorders, Neurologic, Cerebral Palsy, Stroke, Traumatic Brain Injury, Child, Only, Gait Disorders in Children
- Being tested
- Andago, Treadmill
- Keywords
- Andago, Feasibility, Pediatric Neurorehabilitation
- Medical subject headings
- Gait Disorders, Neurologic, Cerebral Palsy, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AndagoDevice
The Andago is a body-weight supporting device with which a patient can walk overground
TreadmillOther
Bodyweight supported treadmill walking
| Study group | Role | What they receive |
|---|---|---|
| Andago | Experimental | Application of walking over-ground with body-weight support in the Andago Receives: Device: Andago |
| Treadmill | Active comparator | Application of walking on a treadmill with body-weight support Receives: Other: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Appointment 3 (between minute 25 and minute 55 )
Secondary outcomes (2)
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
Measured: 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
Measured: Appointment 3 (between minute 25 and minute 55)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start28 May 2018
- Primary completion19 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Lions Club Zürich-Witikon, Mäxi Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787199
- Sponsor's protocol ID
- 2018-00412
- Other IDs
- 2018
- Status last verified
- Apr 2019
- First submitted
- 23 Apr 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have to check with the local ethics committee whether our pseudonymized data can be shared
Publications
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.
PubMed 33557834
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Overground Bodyweight Supporting Walking System Andago
- ClinicalTrials.gov ID
- NCT03787199
- Acronym / sponsor ID
- 2018-00412
- Conditions
- Gait Disorders, Neurologic, Cerebral Palsy, Stroke, Traumatic Brain Injury, Child, Only, Gait Disorders in Children
- Keywords
- Andago, Feasibility, Pediatric Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- Lions Club Zürich-Witikon, Mäxi Foundation
- Study start
- 28 May 2018 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Andago | Experimental | Device: AndagoApplication of walking over-ground with body-weight support in the Andago |
| Treadmill | Active comparator | Other: TreadmillApplication of walking on a treadmill with body-weight support |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AndagoThe Andago is a body-weight supporting device with which a patient can walk overground | Device | Andago |
| TreadmillBodyweight supported treadmill walking | Other | Treadmill |
Primary outcome
Stride to stride variability
Time frame: Appointment 3 (between minute 25 and minute 55 )
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
2 secondary outcomes
Leg muscle activity
Time frame: Appointment 3 (between minute 25 and minute 55 )
Leg joint angles
Time frame: Appointment 3 (between minute 25 and minute 55)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 33557834van 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.
- Individual participant dataSharing planned: Undecided. We have to check with the local ethics committee whether our pseudonymized data can be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Andago and Treadmill in people with Gait Disorders, Neurologic and Cerebral Palsy, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride to stride variability (time frame: Appointment 3 (between minute 25 and minute 55 )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03787199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.