Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06295380
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-21
Brief Title:
Virtual Reality Rehabilitation to Promote Motor Recovery in Amputees
Sponsor:
IRCCS Centro Neurolesi Bonino-Pulejo
Organization:
IRCCS Centro Neurolesi Bonino-Pulejo
Study Overview
Official Title:
Study of Motor Recovery and Biomechanical Adaptation Mechanisms in Amputee Patients Using an Immersive Virtual Reality System CAREN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Interventional non-pharmacological crossover study aimed at identify statistically significant differences in postural stability and spatio-temporal gait cycle parameters in patients with lower limb amputation by means of taskoriented rehabilitation training and multisensory feedback generated by an immersive RV environment aiming at the enhancement of use-dependent brain plasticity These changes will be compared between the two groups examined respectively experimental Caren virtual training phase plus conventional physiotherapy phase and control conventional physiotherapy phase plus Caren virtual training phase
Detailed Description:
Primary objectives Evaluation of biomechanical and spatio-temporal asymmetries in gait in subjects with lower limb amputation by motion capture systems improvement of postural stability and gait cycle in patients with lower limb amputation by task-oriented rehabilitation training and multisensory feedback generated by an immersive virtual reality environment aiming at the enhancement of use-dependent brain plasticity improving body weight distribution on both lower limbs during static and dynamic activities through more effective control of the bodys centre of gravity Secondary objectives include improving mood psycho-social wellbeing and quality of life in lower limb amputees
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