Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06622655

Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy

The goal of this clinical trial is to learn if a two month training with the Agilik powered orthosis improves the knee extension or the endurance in pediatric patients with Cerebral palsy and a crouch gait. It will also learn about the safety of Agilik. The main questions it aims to answer are:

Does the Agilik powered orthosis increase the value of the knee extension during walking? What medical problems do participants have when using the Agilik powered orthosis? Researchers will compare a group of patients using the Agilik powered exoskeleton with a group of patients treated with standard therapy.

Participants will:

Use Agilik at home or perform standard therapy for 2 months Visit the clinic at the beginning of the study, after 3 months and after 1 additional month.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS E. MEDEA - Associazione "La Nostra Famiglia", Bosisio Parini, Lecco, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of CP and a crouch gait
  • Provision of signed and dated informed consent form.
  • Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination.
  • Body weight between 20 and 125 Kg
  • Knee flexion retraction assessed in supine position by less than 10°. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study.
  • Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 5° of passive dorsi-flexion of the ankle.
  • Able to walk at least 3 m without stopping, with or without a walking aid.
  • Able to understand and follow simple directions based on parent report and physician observation during historical and physical examination.
  • GMFCS level I, II and III
  • MAS score ≤ 2

Exclusion criteria

  • Any severe neurological, musculoskeletal and/or cardiorespiratory involvement preventing the ability to walk;
  • A history of uncontrolled seizure in the past year
  • Severe spasticity
  • Hip and/or knee flexion contracture of more than 20°

Treatment and study plan

Powered orthosis

Device

Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.

Primary outcomes

  1. Endurance

    Time frame: Baseline, 3 months and 4 months

    Distance walked during a 6-minutes walking test (6MWT)

  2. Knee extension in mid stance (KEMS)

    Time frame: Baseline, 3 months and 4 months

    Anti-gravity knee extension in mid stance measured with quantitative gait analysis

Secondary outcomes

  1. Measurements of the Joint range of motions (ROMs) and muscle lengths

    Time frame: Baseline, 3 months and 4 months

    Joint Range of motions and muscle lengths as measured by therapists

  2. Level of spasticity in the lower limbs

    Time frame: Baseline, 3 months and 4 months

    Assessed with the Modified Ashworth scale (MAS)

  3. Walking speed

    Time frame: Baseline, 3 months and 4 months

    Assessed with the 10-meter walking test (10mWT)

  4. Postural and motor abilities

    Time frame: Baseline, 3 months and 4 months

    Assessed with the Gross Motor Function Measure-88 (GMFM-88)

  5. Gait pattern

    Time frame: Baseline, 3 months and 4 months

    Assessed with overground 3D gait analysis with electromyography (EMG) data acquisition

  6. Self-perception of performance in everyday living

    Time frame: Baseline, 3 months and 4 months

    Assessed with the Canadian Occupational Performance Measure (COPM)

  7. Static balance

    Time frame: Baseline, 3 months and 4 months

    Assessed with Centre of Pressure (COP) detection using the force platforms of the gait analysis.

  8. Usability and acceptability of the powered orthosis

    Time frame: After the treatment only in the intervention group

    Assessed with the System Usability Scale (SUS) and the Technology Acceptance Method 3 (TAM-3)

  9. Behavioural engagement

    Time frame: After the treatment only in the intervention group

    Assessed with semi-structured interviews

Other outcomes

  1. Spatiotemporal parameters of gait during daily life

    Time frame: Between baseline and month 3

    Remote monitoring of gait behavior assessed with sensorized shoes

Study contacts

Contact information is provided by the study sponsor or research team.

Cristina Maghini, MD

CONTACT

[email protected]

Emilia Biffi, PhD

CONTACT

[email protected]

+39031877862

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Collaborators

  • Fondazione Don Carlo Gnocchi ETS
  • IRCCS Fondazione Stella Maris
  • IRCCS National Neurological Institute "C. Mondino" Foundation

Registry information

Official study title

Agilik@Home: Demonstrate the Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy

Acronym: Agilik@home

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.