Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620198
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Upper Limb Robot-Assisted Therapy in Patients with Guillain-Barré Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Robot-Assisted Therapy for Upper Limb Functional Recovery in Patients with Guillain-Barré Syndrome a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAUL-Project
Brief Summary:
Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy with around 100000 new cases reported worldwide annually
The aim of this double-blind randomized controlled trial with a SHAM control group is to evaluate the effects of robot-assisted therapy integrated with conventional therapy on upper limb motor recovery in patients with GBS
The aim of this double-blind randomized controlled trial with a SHAM control group is to evaluate the effects of robot-assisted therapy integrated with conventional therapy on upper limb motor recovery in patients with GBS
Detailed Description:
Guillain-Barré Syndrome is a leading cause of acute flaccid paralysis presenting with limb weakness and hyporeflexia or areflexia Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy with around 100000 new cases reported worldwide annually This study aims to assess the effectiveness of a robot-assisted rehabilitation treatment for upper limb motor recovery in patients with Guillain-Barré Syndrome A double-blind randomized trial will be conducted where the experimental group will undergo actual robotic rehabilitation sessions while the control group will perform sessions in which the robot will carry out simple mobilization comparable to traditional interventions This approach will help maintain participant blinding Patients will be evaluated before and after treatment and with two follow-up assessments 60 and 90 days after therapy initiation Evaluations will include muscle recruitment and autonomy in daily living activities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None