Feasibility of the ANDAGO System in Pediatric Neurorehabilitation
Condition: Central Motor Disorders; Orthopedic Disorders
MeSH terms: Musculoskeletal Diseases; Motor Disorders
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): ANDAGO; ANDAGO; ANDAGO; ANDAGO; ANDAGO
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Feasibility: the researchers 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/walking with regular walking aids.; 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 (i.e. whether patients can improve relatively quickly (i.e. 30 minutes of practice time) in dynamic tasks).; To investigate how well healthy age- and gender matched children can perform the dynamic tasks (obstacle and precision course) and compare these results to those obtained in patients.
Other intervention name(s): ANDAGO-1; ANDAGO-2; ANDAGO-3; ANDAGO-4; ANDAGO-5
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Children; Adolescents