Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419322
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-02
Brief Title:
Acceptability Feasibility Safety and Efficacy of a Optimized Rehabilitation Program for Treated Patients With Spinal Muscular Atrophy SMA
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACE SMA
Brief Summary:
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 on their own
Detailed Description:
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 individual patient All study participants will receive the optimized rehabilitation program over 12 months An external control group will be used to determine the potential efficacy
Research study visits will take place at baseline month 6 and month 12 At these visits a general physical exam will be undertaken alongside collecting the participant and carer perception satisfaction and compliancy of the rehabilitation program Motor function assessments according to age and ambulatory status will be assessed to help evaluate potential therapeutic benefits
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 individual patient All study participants will receive the optimized rehabilitation program over 12 months An external control group will be used to determine the potential efficacy
Research study visits will take place at baseline month 6 and month 12 At these visits a general physical exam will be undertaken alongside collecting the participant and carer perception satisfaction and compliancy of the rehabilitation program Motor function assessments according to age and ambulatory status will be assessed to help evaluate potential therapeutic benefits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PID17165 | OTHER | University Oxford Hospitals NHS Foundation Trust | None |