Clinical Improvement Due to the Home Use of Agilik in Children With Cerebral Palsy (Agilik@home)

June 24, 2026 updated by: IRCCS Eugenio Medea

Agilik@Home: Demonstrate the 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20148
        • Recruiting
        • Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente
        • Contact:
      • Pavia, Italy, 27100
      • Roma, Italy, 00194
        • Recruiting
        • Fondazione Don Carlo Gnocchi Onlus
        • Contact:
      • Salerno, Italy, 84131
        • Recruiting
        • Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare
        • Contact:
    • Lecco
      • Bosisio Parini, Lecco, Italy, 23842
        • Recruiting
        • IRCCS E. MEDEA - Associazione "La Nostra Famiglia"
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Fabio A Storm, PhD
        • Sub-Investigator:
          • Roberta Nossa, PhD
        • Sub-Investigator:
          • Eleonora Diella, PT
    • Pisa
      • Calambrone, Pisa, Italy, 56128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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°

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: Intervention Arm
Home rehabilitation
Device: Powered orthosis
Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endurance
Time Frame: Baseline, 3 months and 4 months
Distance walked during a 6-minutes walking test (6MWT)
Baseline, 3 months and 4 months
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
Baseline, 3 months and 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 months and 4 months
Level of spasticity in the lower limbs
Time Frame: Baseline, 3 months and 4 months
Assessed with the Modified Ashworth scale (MAS)
Baseline, 3 months and 4 months
Walking speed
Time Frame: Baseline, 3 months and 4 months
Assessed with the 10-meter walking test (10mWT)
Baseline, 3 months and 4 months
Postural and motor abilities
Time Frame: Baseline, 3 months and 4 months
Assessed with the Gross Motor Function Measure-88 (GMFM-88)
Baseline, 3 months and 4 months
Gait pattern
Time Frame: Baseline, 3 months and 4 months
Assessed with overground 3D gait analysis with electromyography (EMG) data acquisition
Baseline, 3 months and 4 months
Self-perception of performance in everyday living
Time Frame: Baseline, 3 months and 4 months
Assessed with the Canadian Occupational Performance Measure (COPM)
Baseline, 3 months and 4 months
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.
Baseline, 3 months and 4 months
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)
After the treatment only in the intervention group
Behavioural engagement
Time Frame: After the treatment only in the intervention group
Assessed with semi-structured interviews
After the treatment only in the intervention group

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatiotemporal parameters of gait during daily life
Time Frame: Between baseline and month 3
Remote monitoring of gait behavior assessed with sensorized shoes
Between baseline and month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Eugenio Medea

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 2, 2024

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIP1122
  • PNC0000007 (Other Grant/Funding Number: Ministry of University and Research of Italy)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The results obtained at the end of this clinical trial will be presented at national and international conferences and submitted to peer-reviewed international journals. The raw data of the study will be published among the supplementary materials of scientific articles and/or uploaded to Zenodo, a multidisciplinary repository, managed by CERN in Geneva, which allows researchers to share and preserve research results in any size and form. Depositing data in ZENODO guarantees their compliance with the FAIR principles.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe