Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02814513 |
| Other study ID # |
ANDAGO |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
June 23, 2016 |
| Last updated |
May 3, 2017 |
| Start date |
June 2016 |
| Est. completion date |
September 27, 2016 |
Study information
| Verified date |
May 2017 |
| Source |
University Children's Hospital, Zurich |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Background and Rationale:
Children with neurological diagnoses including congenital or acquired brain lesions often
have impaired lower extremity function limiting the independence in daily life activities.
Achieving the ability to stand and walk independently is mentioned by most children and
their parents as the highest priority for the neurorehabilitation process. Robotic gait
therapy can deliver high-dosage (i.e. number of practice movements) and high-intensive (i.e.
number of movements per unit time) training interventions to complement conventional
treatments. Nevertheless, there is a gap between treadmill-based gait training and free
walking. HocomaAG (Volketswil) developed a new mobile robot for body-weight supported gait
training. ANDAGO will bridge this gap while offering a safe and functional environment for
patients. Now, the researchers would like to investigate whether it is feasible to apply
this prototype to children and adolescents undergoing neurorehabilitation.
Objective(s):
As the device has not been applied in a pediatric rehabilitation setting yet, the
researchers want to investigate:
- Feasibility: the investigators will examine technical features as well as
patient-related aspects, safety and operability of the device during static (standing)
and dynamic (walking) tasks.
- Differences in static and dynamic tasks when standing/walking in the ANDAGO or when
being supervised by a therapist.
- Investigate the handling of the ANDAGO. Patients will have time to practice with the
device and Background and Rationale:
Children with neurological diagnoses including congenital or acquired brain lesions often
have impaired lower extremity function limiting the independence in daily life activities.
Achieving the ability to stand and walk independently is mentioned by most children and
their parents as the highest priority for the neurorehabilitation process. Robotic gait
therapy can deliver high-dosage (i.e. number of practice movements) and high-intensive (i.e.
number of movements per unit time) training interventions to complement conventional
treatments. Nevertheless, there is a gap between treadmill-based gait training and free
walking. HocomaAG (Volketswil) developed a new mobile robot for body-weight supported gait
training. ANDAGO will bridge this gap while offering a safe and functional environment for
patients. Now, the researchers would like to investigate whether it is feasible to apply
this prototype to children and adolescents undergoing neurorehabilitation.
Objective(s):
As the device has not been applied in a pediatric rehabilitation setting yet, the
researchers want to investigate:
- Feasibility: the investigators will examine technical features as well as
patient-related aspects, safety and operability of the device during static (standing)
and dynamic (walking) tasks.
- Differences in static and dynamic tasks when standing/walking in the ANDAGO or when
being supervised by a therapist.
- Investigate the handling of the ANDAGO. Patients will have time to practice with the
device and the researchers will evaluate improvements in static/dynamic task
performance with the ANDAGO.
- Determine which patients (characterized by demographics and neurological, cognitive and
functional status) can improve their handling with the ANDAGO.
- To investigate how well healthy age- and gender matched children can perform the
dynamic tasks (obstacle and precision course).
Outcome(s):
Feasibility: outcomes focus on the applicability of the ANDAGO according to therapists' and
patients' feedback. The questionnaire includes questions on satisfaction with operability,
comfort, safety and the handling of the device, the harnesses and the control panel.
Furthermore the researchers will investigate the precision of the symmetric unloading system
with the help of a digital weight scale that the patient steps onto.
The researchers further investigate static balance with a Kistler force plate (Center of
Pressure parameters) and time and accuracy of walking with and without the ANDAGO when
performing an obstacle and precision course. The investigators will record outcomes like
time required to perform the tasks, gait quality with the Edinburgh Visual Gait Score and
smoothness of walking with Shimmer sensors, and walking precision with a GoPro camera.
Finally, the researchers assess various characteristics and functional and cognitive
outcomes of the patients to correlate these measures with performance and handling of the
ANDAGO.
The investigators do not apply any invasive measures and assure that the testing procedures
will be limited to keep the burden for the participants acceptable.
Study design:
Open label feasibility study investigating the applicability, safety and handling of the
ANDAGO system. Two appointments will be planned for each child within a 48 hour window in
order to avoid possible functional improvements due to other therapies. One additional
appointment might be planned for clinical, functional or neurological tests that are
normally part of our clinical routines. Healthy participants will be appointed only once.
Inclusion/Exclusion criteria:
Children and adolescents from our Rehabilitation Centre, aged between 5 and 18 years, will
be included in this project. The investigators expect to recruit 30 participants with
central motor disorders or orthopaedic disorders including lower extremity impairments.
Further inclusion criteria are: 1) patients larger than 135 cm, 2) capability to understand
and follow simple verbal commands, 3) ability to initiate steps.
The exclusion criteria are: 1) bone fragility of the lower extremities, 2) inability to
maintain upright position and lack of head control, 3) uncontrolled hip, knee or ankle
instability, 4) elevated risk of seizure, 5) lower extremity contractions (knee > 20°, hip >
20°), 6) presence of skin lesions in areas of contact with the harness support or on feet,
7) implantation of baclofen pump, heart pacemaker or cerebral shunt, 8) cognitive deficit
limiting communication of pain or discomfort, 9) limited compliance or aggressive behaviour,
10) any surgical correction or botulinum toxic injection in the lower extremities in the
last two months.
Healthy children and adolescents should have no cardiovascular, neurological or
musculoskeletal diagnoses.
Measurements and procedures:
Clinical assessments will be performed by therapists to assess the child's functional status
regarding muscle strength, selective joint control, spasticity, gait ability and cognitive
function.
All exercises will be performed with and without the ANDAGO in a randomized order by each
participant.
At the beginning of the first appointment, a standing exercise on a Kistler's force plate
will be done. Afterwards the dynamic part of the exercise will be conducted. Participants
have to walk along a given path and perform a precision course, followed by an obstacle
course. During the second appointment, the participant practices with the ANDAGO and then
performs the same obstacle and precision course. Improvements will be objectified by reduced
time needed, lower number of prevented falls, higher precision, better gait quality,
improved smoothness of walking etc. During the measurements, the children walk with
self-selected speed (maximum velocity is 2.1 km/h) and individually adjusted body weight
unloading.
Study Product / Intervention:
The ANDAGO V2.0 is a new device. It consists of a stable walking frame and allows a patient
to walk with reduced body-weight and without falling over-ground.
Control Intervention (if applicable):
This is a feasibility study, not an RCT; for some tests, the researchers investigate
differences in the children's gait capacity when walking with the ANDAGO or without or
differences between healthy children and children undergoing neuro-orthopaedic
rehabilitation.
Number of Participants with Rationale:
According to the literature, feasibility studies interested in discovering usability for
early prototypes are considered valid when including 3-20 participants (Macefield 2008). Due
to our heterogeneous patient groups and the potential of some drop-outs, the investigators
aim to recruit 30 patients (and an equal number of healthy age- and gender matched
controls). These numbers should also be sufficient to detect tendencies of differences
within patients (performing static and dynamic tasks with versus without ANDAGO, or
improving their handling) or between patients and healthy controls (i.e. differences in the
performance of the dynamic tasks between these groups).
Study Duration:
June 2016 - February 2017.
Study Centre(s):
Monocentric study: Rehabilitation Center Affoltern am Albis
Statistical Considerations:
This is not an RCT; therefore there is no primary hypothesis and an accompanying sample size
calculation. Depending on the distribution of the data, parametric or non-parametric
analyses (e.g. paired-t-test or Wilcoxon signed-rank test for within group differences and
t-test or Mann-Whitney U tests for between group comparisons) will be performed. The
investigators will correct for multiple comparisons (e.g. Bonferroni correction). Pearson's
or Spearman correlations coefficients will be calculated between demographic characteristics
and clinical measures versus measures indicating improved handling.
GCP Statement:
This study will be conducted in compliance with the protocol, the current version of the
Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all
national legal and regulatory requirements. will evaluate improvements in static/dynamic
task performance with the ANDAGO.
- Determine which patients (characterized by demographics and neurological, cognitive and
functional status) can improve their handling with the ANDAGO.
- To investigate how well healthy age- and gender matched children can perform the
dynamic tasks (obstacle and precision course).
Outcome(s):
Feasibility: outcomes focus on the applicability of the ANDAGO according to therapists' and
patients' feedback. The questionnaire includes questions on satisfaction with operability,
comfort, safety and the handling of the device, the harnesses and the control panel.
Furthermore the researchers will investigate the precision of the symmetric unloading system
with the help of a digital weight scale that the patient steps onto.
The researchers further investigate static balance with a Kistler force plate (Center of
Pressure parameters) and time and accuracy of walking with and without the ANDAGO when
performing an obstacle and precision course. The investigators will record outcomes like
time required to perform the tasks, gait quality with the Edinburgh Visual Gait Score and
smoothness of walking with Shimmer sensors, and walking precision with a GoPro camera.
Finally, the researchers assess various characteristics and functional and cognitive
outcomes of the patients to correlate these measures with performance and handling of the
ANDAGO.
The investigators do not apply any invasive measures and assure that the testing procedures
will be limited to keep the burden for the participants acceptable.
Study design:
Open label feasibility study investigating the applicability, safety and handling of the
ANDAGO system. Two appointments will be planned for each child within a 48 hour window in
order to avoid possible functional improvements due to other therapies. One additional
appointment might be planned for clinical, functional or neurological tests that are
normally part of our clinical routines. Healthy participants will be appointed only once.
Inclusion/Exclusion criteria:
Children and adolescents from our Rehabilitation Centre, aged between 5 and 18 years, will
be included in this project. The investigators expect to recruit 30 participants with
central motor disorders or orthopaedic disorders including lower extremity impairments.
Further inclusion criteria are: 1) patients larger than 135 cm, 2) capability to understand
and follow simple verbal commands, 3) ability to initiate steps.
The exclusion criteria are: 1) bone fragility of the lower extremities, 2) inability to
maintain upright position and lack of head control, 3) uncontrolled hip, knee or ankle
instability, 4) elevated risk of seizure, 5) lower extremity contractions (knee > 20°, hip >
20°), 6) presence of skin lesions in areas of contact with the harness support or on feet,
7) implantation of baclofen pump, heart pacemaker or cerebral shunt, 8) cognitive deficit
limiting communication of pain or discomfort, 9) limited compliance or aggressive behaviour,
10) any surgical correction or botulinum toxic injection in the lower extremities in the
last two months.
Healthy children and adolescents should have no cardiovascular, neurological or
musculoskeletal diagnoses.
Measurements and procedures:
Clinical assessments will be performed by therapists to assess the child's functional status
regarding muscle strength, selective joint control, spasticity, gait ability and cognitive
function.
All exercises will be performed with and without the ANDAGO in a randomized order by each
participant.
At the beginning of the first appointment, a standing exercise on a Kistler's force plate
will be done. Afterwards the dynamic part of the exercise will be conducted. Participants
have to walk along a given path and perform a precision course, followed by an obstacle
course. During the second appointment, the participant practices with the ANDAGO and then
performs the same obstacle and precision course. Improvements will be objectified by reduced
time needed, lower number of prevented falls, higher precision, better gait quality,
improved smoothness of walking etc. During the measurements, the children walk with
self-selected speed (maximum velocity is 2.1 km/h) and individually adjusted body weight
unloading.
Study Product / Intervention:
The ANDAGO V2.0 is a new device. It consists of a stable walking frame and allows a patient
to walk with reduced body-weight and without falling over-ground.
Control Intervention (if applicable):
This is a feasibility study, not an RCT; for some tests, the researchers investigate
differences in the children's gait capacity when walking with the ANDAGO or without or
differences between healthy children and children undergoing neuro-orthopaedic
rehabilitation.
Number of Participants with Rationale:
According to the literature, feasibility studies interested in discovering usability for
early prototypes are considered valid when including 3-20 participants (Macefield 2008). Due
to our heterogeneous patient groups and the potential of some drop-outs, we aim to recruit
30 patients (and an equal number of healthy age- and gender matched controls). These numbers
should also be sufficient to detect tendencies of differences within patients (performing
static and dynamic tasks with versus without ANDAGO, or improving their handling) or between
patients and healthy controls (i.e. differences in the performance of the dynamic tasks
between these groups).
Study Duration:
June 2016 - February 2017.
Study Centre(s):
Monocentric study: Rehabilitation Center Affoltern am Albis
Statistical Considerations:
This is not an RCT; therefore there is no primary hypothesis and an accompanying sample size
calculation. Depending on the distribution of the data, parametric or non-parametric
analyses (e.g. paired-t-test or Wilcoxon signed-rank test for within group differences and
t-test or Mann-Whitney U tests for between group comparisons) will be performed. The
investigators will correct for multiple comparisons (e.g. Bonferroni correction). Pearson's
or Spearman correlations coefficients will be calculated between demographic characteristics
and clinical measures versus measures indicating improved handling.
GCP Statement:
This study will be conducted in compliance with the protocol, the current version of the
Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all
national legal and regulatory requirements.
