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Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting

4 settembre 2026 aggiornato da: ABLE Human Motion S.L.

The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program in a clinical setting.

The secondary objective of the study focuses on obtaining preliminary data on the potential clinical and psychosocial benefits of the product.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a pre-post, single-center, quasi-experimental study with an estimated duration of 17 weeks. The study will be conducted at Som·hi where a minimum of 10 evaluable participants are expected to be recruited within a period of 11 weeks.

After obtaining informed consent, through the Patient Information Sheet and the Informed Consent Form, the selection of the participants will be carried out to determine their inclusion in the study. Subjects who do not meet all the inclusion and exclusion criteria during the screening visit will be excluded from the study. At the latest, one week after the screening visit, the participants will undergo a baseline assessment without the medical device.

Participants will undergo a 10-session training program with the ABLE Kids device for a maximum duration of 3 weeks. Sessions will be conducted 5 times per week. Each session will last approximately 60 minutes. During the training period, session data will be taken to assess the safety and clinical performance of the device. At the latest, one week after the last training session, a post-training assessment will be performed. Finally, two weeks after the last training session, a follow-up assessment will be made to the participants via a telephone call to review any adverse events (AE) reported between the end of the training and the follow-up.

Tipo di studio

Interventistico

Iscrizione (Stimato)

15

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Spagna
    • Girona
      • Girona, Girona, Spagna, 17001
        • Reclutamento
        • Som·hi Rehab
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Minors with gait impairments, ranging from mild to severe, resulting from neurological conditions or muscular weakness
  • Anthropometric measurements compatible with the use of the exoskeleton, particularly:
  • Weight under 75 kg
  • Height between 1.0-1.5 m
  • Hip: maximum distance between greater trochanters of 35 cm
  • Thigh: maximum distance from trochanter to knee joint line of 36 cm
  • Lower leg: maximum distance from knee joint line to shoe sole of 45 cm
  • Medically stable
  • Intact skin in areas in contact with the device
  • Favorable medical assessment for standing, gait training, and weight-bearing activities
  • Signed informed consent from parents or legal guardians, and assent from the minor whenever possible, according to age and cognitive ability

Exclusion Criteria:

  • Severe spasticity in the lower limbs (Modified Ashworth Scale [MAS] > 3)
  • Severe osteoporosis resulting in atraumatic bone fractures
  • Unhealed fractures or history of fragility fractures in the lower extremities within the past 2 years
  • Unstable or painful hip dislocation (Migration Percentage [MP] > 50%)
  • Symptomatic heterotopic ossification with mechanical limitation or pain
  • Anatomical limitations incompatible with proper fitting and safe use of the device:
  • Leg length discrepancy >1.5 cm in the upper segment or >2.0 cm in the lower segment
  • Severe scoliosis (Cobb angle >40° without the possibility of orthotic use during operation)
  • Inability to achieve proper adjustment within the device
  • Joint range of motion limitations preventing use of the exoskeleton:
  • Knee flexion contracture ≥40°
  • Hip flexion contracture ≥20°
  • Rigid equinus foot
  • Spine or lower extremity surgery within the last 3 months
  • Recently implanted pacemakers
  • Inability to communicate pain, fear, or discomfort (verbally or nonverbally)
  • Daytime mechanical ventilation
  • Uncontrolled epileptic seizures
  • Medical or cardiovascular instability
  • Considered unsuitable by physicians and physiotherapists. Any acute medical condition such as fever, infection, respiratory problems, urinary symptoms, uncontrolled pain, new swelling or redness in the extremities, active deep vein thrombosis, or severe comorbidities considered incompatible with the use of ABLE Kids until clinical resolution
  • Absence of head or trunk control in sitting or standing that cannot be compensated through the use of orthotic support during exoskeleton use

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Gait training with exoskeleton
Participants will undergo a 10-session gait training program with the exoskeleton, five times a week for up to 3 weeks. Each session will last 60 minutes.
Dispositivo: ABLE Kids
Participants will undergo a 10-session gait training program with the exoskeleton, five times a week for up to 3 weeks. Each session will last 60 minutes.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numero di passi percorsa
Lasso di tempo: Fino a 6 settimane
In ogni sessione di allenamento dell'andatura, il numero di passaggi effettuati (conteggio dei passi) con il dispositivo verrà automaticamente misurato e registrato dal dispositivo
Fino a 6 settimane
Distanza camminata
Lasso di tempo: Fino a 6 settimane
In ogni sessione di allenamento dell'andatura, la distanza camminata (in metri) con il dispositivo verrà automaticamente misurata e registrata dal dispositivo
Fino a 6 settimane
Tempo trascorso in posizione verticale e tempo trascorso a camminare
Lasso di tempo: Fino a 6 settimane
In ogni sessione di allenamento dell'andatura, il tempo trascorso in posizione verticale (in pochi minuti) e il tempo trascorso a camminare (in pochi minuti) con il dispositivo verrà automaticamente misurato e registrato dal dispositivo
Fino a 6 settimane
Number of people assisting the session
Lasso di tempo: Up to 6 weeks
In each gait training session, the number of people assisting will be recorded
Up to 6 weeks
Number and type of device-related Adverse Events
Lasso di tempo: From baseline to follow-up (up to 2 weeks after end of intervention)
To assess safety, the number of Serious Adverse Events (SAE), Adverse Events (AE) and drop-outs due to the device will be assessed and reported.
From baseline to follow-up (up to 2 weeks after end of intervention)
Time taken to don/doff the device
Lasso di tempo: Up to 3 weeks
The time taken to don/doff the device will be measured in every session. Time will be measured in minutes and seconds for each activity. Donning time will start from the moment the participant is ready to transfer into the device until all the straps and clips are correctly tightened. Doffing time will start from the moment the participant starts taking off the device until they have completely removed it.
Up to 3 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gross Motor Function Measure-88
Lasso di tempo: At baseline (day 0) and post-training (up to 4 weeks)
The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument designed to assess changes in gross motor function in children with motor impairments. It consists of 88 items grouped into five dimensions: lying and rolling, sitting, crawling and kneeling, standing, and walking/running/jumping. Each item is scored on a 4-point ordinal scale, with higher scores indicating better gross motor performance.
At baseline (day 0) and post-training (up to 4 weeks)
Motor Function Measure-20
Lasso di tempo: At baseline (day 0) and post-training (up to 4 weeks)
The Motor Function Measure-20 (MFM-20) is a validated scale used to assess motor function in children with neuromuscular disorders. It evaluates functional abilities across three domains: standing position and transfers, axial and proximal motor function, and distal motor function. The scale consists of 20 items scored on a 4-point ordinal scale, with higher scores reflecting better motor performance.
At baseline (day 0) and post-training (up to 4 weeks)
Modified Ashworth Scale (MAS)
Lasso di tempo: At selection, baseline and post-training (up to 4 weeks)
The Modified Ashworth Scale (MAS) measures spasticity in patients with lesions to the central nervous system. The scale assigns a grade of spasticity from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
At selection, baseline and post-training (up to 4 weeks)
Lower extremity muscle strength
Lasso di tempo: At baseline (day 0) and post-training (up to 4 weeks)
The Daniels Muscle Testing scale will be used to measure the strength of muscles in the lower extremities. Scores range from 0 (absence of muscle activity) to 5 (normal muscle activity)
At baseline (day 0) and post-training (up to 4 weeks)
10-Meter Walk Test (10MWT)
Lasso di tempo: At baseline (day 0) and post-training (up to 4 weeks)
The 10-Meter Walk Test (10MWT) measures the time a person needs to walk 10 meters. This test will be performed in the pre-post evaluations without the device to assess the change in the walking function after the training.
At baseline (day 0) and post-training (up to 4 weeks)
2-Minute Walk Test (2MWT)
Lasso di tempo: At baseline (day 0) and post-training (up to 4 weeks)
The 2-Minute Walk Test (2MWT) measures the distance a person can walk in 2 minutes. This test will be assessed at baseline and at the end of the gait training program without the device to assess the change in the walking function after the training
At baseline (day 0) and post-training (up to 4 weeks)
Pediatric Balance Scale (PBS)
Lasso di tempo: At baseline and post-training (up to 4 weeks)
The Pediatric Balance Scale (PBS) is a standardized clinical assessment used to evaluate functional balance in children. Adapted from the Berg Balance Scale, it consists of 14 tasks commonly performed in everyday activities, such as sitting, standing, reaching, turning, and transferring. Each item is scored on a 5-point scale from 0 to 4, with higher scores indicating better balance performance.
At baseline and post-training (up to 4 weeks)
Location and level of pain - Faces Pain Scale-Revised
Lasso di tempo: From baseline to post-training (up to 4 weeks)
The Faces Pain Scale-Revised (FPS-R) is a self-report instrument used to assess pain intensity in children. The scale presents a series of faces representing increasing levels of pain intensity, allowing participants to select the face that best matches their pain experience. Pain location is additionally recorded based on the participant's report. Higher scores indicate greater pain intensity.
From baseline to post-training (up to 4 weeks)
OMNI Rating of Perceived Exertion
Lasso di tempo: From baseline to post-training (up to 4 weeks)
The OMNI Rating of Perceived Exertion Scale is a validated self-report measure used to assess perceived physical effort during exercise in pediatric populations. The scale combines numerical ratings with verbal descriptors and pictorial representations to help children quantify their level of exertion during physical activity. Higher scores indicate greater perceived exertion.
From baseline to post-training (up to 4 weeks)
Functional Independence Measure for Children (WeeFIM)
Lasso di tempo: At baseline and post-training (up to 4 weeks)
The Functional Independence Measure for Children (WeeFIM) is a standardized instrument used to assess functional independence in children. It evaluates performance in self-care, mobility, and cognition through 18 items scored on a 7-level scale, where 1 indicates total assistance and 7 indicates complete independence. Higher scores reflect greater functional independence in activities of daily living.
At baseline and post-training (up to 4 weeks)
Self-perceived impact on general health status
Lasso di tempo: At post-training (up to 4 weeks)
Participants' perceptions of the impact on their general health will be evaluated by the completion of a self-report questionnaire on the perceived impact on general health. This questionnaire has been designed by the researchers and intends to identify to what extent participants feel that the ABLE Kids contributed to a change in their health. The questionnaire covers 7 categories (cardiovascular system, musculoskeletal pain, neuropathic pain, bladder and bowel, skin, spasticity, and sleep quality) using a 7-point Likert scale to assess the change.
At post-training (up to 4 weeks)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) score
Lasso di tempo: At post-training (up to 4 weeks)
The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components (Device and Services) using a 5-point scale ranging from 1 (not satisfied) to 5 (very satisfied). Only the 8 items referred to the device will be evaluated from participants and the whole 12 items from the therapists to measure user satisfaction with the ABLE Kids after the training program experience
At post-training (up to 4 weeks)
EuroQol 5 Dimensions Youth - 5 Levels (EQ-5D-Y-5L)
Lasso di tempo: At baseline and post-training (up to 4 weeks)
The EQ-5D-Y-5L is a standardized self-reported instrument used to assess health-related quality of life in children and adolescents. It evaluates five dimensions: mobility, looking after myself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy. Each dimension is rated on a 5-level scale ranging from "no problems" to "extreme problems." The instrument also includes a EuroQol Visual Analogue Scale (EQ VAS) for the participant's overall perception of their health status.
At baseline and post-training (up to 4 weeks)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

ABLE Human Motion S.L.

Collaboratori

Som·hi Rehab

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2026

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

31 dicembre 2026

Date di iscrizione allo studio

Primo inviato

30 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 luglio 2026

Primo Inserito (Effettivo)

4 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ABLEkidsSP

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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