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Die klinische Studie NCT06419322 (ACE SMA) für Spinale Muskelatrophie ist aktiv, nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Acceptability, Feasibility, Safety and Efficacy of a Optimized Rehabilitation Program for Treated Patients With Spinal Muscular Atrophy (SMA). (ACE SMA) 14 Zu Hause

Aktiv, nicht rekrutierend
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Die klinische Studie NCT06419322 (ACE SMA) ist eine interventionsstudie zur Untersuchung von Spinale Muskelatrophie und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 1. Juni 2024 und soll 14 Teilnehmer aufnehmen. Durchgeführt von Universität Oxford ist der Abschluss für 1. Dezember 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 3. Februar 2025 aktualisiert.
Kurzbeschreibung
The goal of this study is to investigate the acceptability, feasibility, safety and efficacy of an optimized rehabilitation program for treated patients with spinal muscular atrophy (SMA) compared to the current rehabilitation program in the United Kingdom. The aim is to provide patients with more hands on physiotherapy and access to rehabilitation devices at home to support parents currently providing rehabilitation...Mehr anzeigen
Ausführliche Beschreibung
The main study objective is to investigate whether an optimized rehabilitation program would be accepted and is feasible within the SMA patient community.

The optimized program will comprise of goal orientated rehabilitation with more frequent hands on physiotherapy (every 2 weeks) as well as a SMA approved rehabilitation device used at home on a weekly basis, to provide the most appropriate therapy for each individ...

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Offizieller Titel

A Monocentric, Prospective and Longitudinal Study Investigating the Acceptability, Feasibility, Safety and Efficacy of an Optimized Rehabilitation Program for Treated Patients With SMA Compared to the Current Rehabilitation Program in United Kingdom: ACE SMA.

Erkrankungen
Spinale Muskelatrophie
Weitere Studien-IDs
  • ACE SMA
  • PID17165 (Andere Kennung) (University Oxford Hospitals NHS Foundation Trust)
NCT-Nummer
NCT06419322
Studienbeginn (tatsächlich)
2024-06-01
Zuletzt aktualisiert
2025-02-03
Studienende (vorauss.)
2026-12
Geplante Rekrutierung
14
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Stichwörter
physiotherapy
rehabilitation
SMA
acceptability
feasibility
United Kingdom
physical therapy
prospective
Spinal Muscular Atrophy
Primäres Ziel
Andere
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
AndereTreated cohort
Optimized rehabilitation program
Consisting of: goal-oriented rehabilitation, hands on physiotherapy sessions and home use of SMA approved rehabilitation device.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Acceptability of an optimized rehabilitation program. Measured as number of eligible patients who accepted to participate in the study compared to the number of eligible patients who have refused to participate. Endpoint: 70% of acceptability.
Number of eligible patients who accepted to participate in the study compared to the number of eligible patients who have refused to participate.
Baseline visit
Feasibility of an optimized rehabilitation program. Measured as the number of patients who complete the study compared to the number of included patients. Endpoint: 60% of feasibility.
Number of patients who complete the study compared to the number of included patients.
Month 12 (end of study)
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Safety of an optimized rehabilitation program. Measured as the number of serious adverse events (SAE) compared to the year before the baseline.
Number of Serious Adverse Events (SAEs).
From baseline to month 12 (end of study)
Carer perception and satification measured through the Clinical Global Impression scale - Improvement (CGI I). Comparison of CGI-S score with CGI-I score of the treated group.
Potential effects of the optimized rehabilitation program on patients experience.
Month 6 and Month 12 (end of study).
Carer perception and satification measured through the Clinical Global Impression scale - Severity (CGI-S). Comparison of CGI-S score with CGI-I score of the treated group.
Potential effects of the optimized rehabilitation program on patients experience.
Baseline visit: CGI-S.
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Kind
Mindestalter
1 Year
Zugelassene Geschlechter
Alle
Patient participant Eligibility Criteria:
  • Genetically confirmed SMA considered as a non-sitter, sitter or walker
  • Post-symptomatically treated and on stable dose for 12 months with any disease-modifying market-approved drug
  • Patients from 1-10 years of age at baseline
  • Parent(s)/legal guardian(s) of patients less than 16 years of age must provide written informed consent prior to the patient's participation in the study
  • Willing and able to comply with all protocol requirements and procedures.

The participant may not enter the trial if ANY of the following apply:

  • Any acute or chronic condition which, as assessed by the investigator, significantly interferes with the rehabilitation of the patient
  • Need of diurnal and/or invasive ventilation, naps excluded
  • Currently enrolled in a treatment study; or treatment with an experimental therapy
  • Any surgical and/or medical intervention, according to the investigator, 3 months before baseline and/or during the study participation.

Carer (considered as participant) Eligibility Criteria:

Inclusion Criteria:

  • Willing and able to comply with all protocol requirements and procedures
  • Carer's child has been included in study.

Exclusion Criteria:

• No exclusion criteria.

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Oxfordshire

Oxford Brookes University, Oxford, Oxfordshire, OX3 0BP, United Kingdom