Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576947
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Virtual Reality in the Treatment of Pelvic Floor Dysfunction in Women With Multiple Sclerosis A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The purpose of the current randomized clinical trial was to compare the effectiveness of virtual reality versus posterior tibial nerve stimulation on the improvement of pelvic floor dysfunctions in women with multiple sclerosis
Detailed Description:
Design Randomized Clinical Trial Objective to determine the effects of virtual reality versus posterior tibial nerve stimulation and muscle activation exercises on the improvement of pelvic floor dysfunctions in women with multiple sclerosis
Methods and Measures forty five women will be randomly assigned to one of three groups
Intervention For 8-week the group 1 will undergo treatment with virtual reality 2week the group 2 will receive posterior tibial nerve stimulation 2week and the group 3 will receive muscle activation exercises of the pelvic floor
Main Outcome Measures assessment of pelvic floor muscles function strength and muscle tone urodynamic studies and validated questionnaires data will be collected at baseline and 1 week after the last therapy application Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure
Methods and Measures forty five women will be randomly assigned to one of three groups
Intervention For 8-week the group 1 will undergo treatment with virtual reality 2week the group 2 will receive posterior tibial nerve stimulation 2week and the group 3 will receive muscle activation exercises of the pelvic floor
Main Outcome Measures assessment of pelvic floor muscles function strength and muscle tone urodynamic studies and validated questionnaires data will be collected at baseline and 1 week after the last therapy application Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure
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