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| ID | Type | Description | Link |
|---|---|---|---|
| PNC0000007 | Other Grant/Funding Number | Italian Ministry of Research |
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| Name | Class |
|---|---|
| IRCCS Fondazione Stella Maris | OTHER |
| Fondazione Don Carlo Gnocchi ETS | OTHER |
| IRCCS National Neurological Institute "C. Mondino" Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Home rehabilitation |
|
| Control Group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powered orthosis | Device | Home rehabilitation (2 months, 30 minutes/day, 5 days/week) during which subjects will practice walking with the device at home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endurance | Distance walked during a 6-minutes walking test (6MWT) | Baseline, 3 months and 4 months |
| Knee extension in mid stance (KEMS) | Anti-gravity knee extension in mid stance measured with quantitative gait analysis | Baseline, 3 months and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of the Joint range of motions (ROMs) and muscle lengths | Joint Range of motions and muscle lengths as measured by therapists | Baseline, 3 months and 4 months |
| Level of spasticity in the lower limbs |
| Measure | Description | Time Frame |
|---|---|---|
| Spatiotemporal parameters of gait during daily life | Remote monitoring of gait behavior assessed with sensorized shoes | Between baseline and month 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilia Biffi, PhD | Contact | +39031877862 | emilia.biffi@lanostrafamiglia.it | |
| Cristina Maghini, MD | Contact | cristina.maghini@lanostrafamiglia.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS E. MEDEA - Associazione "La Nostra Famiglia" | Recruiting | Bosisio Parini | Lecco | 23842 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41880375 | Derived | Nossa R, Storm FA, Diella E, Riboni R, Molteni LE, Chiappini M, Maghini C, Beretta E, Nicotra R, Abbondio S, Ferrante C, Cotardo A, Sgherri G, Germanotta M, Mauro MC, Fasano A, Cordoni C, Ferrarin M, Cavallini A, Signorini SG, Sgandurra G, Aprile I, Iuvone L, Cavalagli A, Biffi E; Agilik@home Study Group. Agilik@home: A randomized controlled trial protocol to evaluate the effects of home-based training with the Agilik powered KAFO in children with cerebral palsy and crouch gait. PLoS One. 2026 Mar 25;21(3):e0340877. doi: 10.1371/journal.pone.0340877. eCollection 2026. |
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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.
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Assessed with the Modified Ashworth scale (MAS)
| Baseline, 3 months and 4 months |
| Walking speed | Assessed with the 10-meter walking test (10mWT) | Baseline, 3 months and 4 months |
| Postural and motor abilities | Assessed with the Gross Motor Function Measure-88 (GMFM-88) | Baseline, 3 months and 4 months |
| Gait pattern | Assessed with overground 3D gait analysis with electromyography (EMG) data acquisition | Baseline, 3 months and 4 months |
| Self-perception of performance in everyday living | Assessed with the Canadian Occupational Performance Measure (COPM) | Baseline, 3 months and 4 months |
| Static balance | 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 | 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 | Assessed with semi-structured interviews | After the treatment only in the intervention group |
| IRCCS Fondazione Stella Maris | Not yet recruiting | Calambrone | Pisa | 56128 | Italy |
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| Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente | Recruiting | Milan | 20148 | Italy |
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| Fondazione Mondino | Not yet recruiting | Pavia | 27100 | Italy |
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| Fondazione Don Carlo Gnocchi Onlus | Recruiting | Roma | 00194 | Italy |
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| Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare | Recruiting | Salerno | 84131 | Italy |
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