Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538974
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and or Deficiencies in Adult Population
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adherence to Long-term Exoskeleton Rehabilitation to Treat Lower Limb Weakness and or Deficiencies in Adult Population
Status:
RECRUITING
Status Verified Date:
2024-07
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:
ALERT
Brief Summary:
In 2019 approximately 24 billion people worldwide required rehabilitation for various health pathologies a 63 increase since 1990 It has been suggested that current rehabilitation frameworks inpatient outpatient and community-based are insufficient to meet local population needs due to issues like long waiting times lack of facilities prioritization funding and accessibilityPatients with lower limb weaknesses resulting from various conditions for example stroke traumatic brain injury spinal cord injury and others require long-term management and motivation for engagement which are crucial for functional outcomes This highlights the need for sustainable gait and balance rehabilitation
New technologies like exoskeletons have shown promising results in short-term inpatient programs improving gait balance and quality of life however long-term follow-up data are still needed
The present clinical investigation is a national prospective open-label interventional trial proposing a 12-month outpatient rehabilitation program with the Atalante X exoskeleton to treat lower limb weakness andor impairments in 100 participants The rehabilitation program consists of at least one exoskeleton rehabilitation session per week At the end of the first-year experimental phase participants can continue for an additional year in the voluntary phase The program aims to explore the potential long-term effects of supervised robotic rehabilitation on motor cognitive bowel bladder functions quality of life and well-being Assessments are conducted at baseline after 4 and 12 months of exoskeleton rehabilitation and at 16 and 24 months for participants in the voluntary phase
New technologies like exoskeletons have shown promising results in short-term inpatient programs improving gait balance and quality of life however long-term follow-up data are still needed
The present clinical investigation is a national prospective open-label interventional trial proposing a 12-month outpatient rehabilitation program with the Atalante X exoskeleton to treat lower limb weakness andor impairments in 100 participants The rehabilitation program consists of at least one exoskeleton rehabilitation session per week At the end of the first-year experimental phase participants can continue for an additional year in the voluntary phase The program aims to explore the potential long-term effects of supervised robotic rehabilitation on motor cognitive bowel bladder functions quality of life and well-being Assessments are conducted at baseline after 4 and 12 months of exoskeleton rehabilitation and at 16 and 24 months for participants in the voluntary phase
Detailed Description:
None
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