Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT04530669
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2020-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
Sponsor:
Lama Saad El-Din Mahmoud
Organization:
Study Overview
Official Title:
The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2021-07
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:
To investigate the effect of "High Tone Power Therapy" (HTPT) on fatigue and functional outcomes in multiple sclerosis (MS). BACKGROUND: Fatigue and functional limitations considered serious disorders in patients with multiple sclerosis that lead to impairment of the physical activities and disruption of the quality of life (QOL).
HYPOTHESES:
This study hypothesized that:
High Tone Power Therapy will have a significant beneficial effect on fatigue and functional outcomes in in multiple sclerosis
RESEARCH QUESTION:
Is there a beneficial effect of High Tone Power Therapy on fatigue and functional outcomes in multiple sclerosis?
HYPOTHESES:
This study hypothesized that:
High Tone Power Therapy will have a significant beneficial effect on fatigue and functional outcomes in in multiple sclerosis
RESEARCH QUESTION:
Is there a beneficial effect of High Tone Power Therapy on fatigue and functional outcomes in multiple sclerosis?
Detailed Description:
Double blind randomized study including 40 patients with MS. The patients will be randomly allocated into 2 arms: active arm and placebo arm; in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program, and the placebo arm will receive the same physical exercise program with sham "high tone power therapy". Either program will be applied 3 times per week for 4 weeks.
The evaluation methods will be done using:
* Expanded Disability Status Scale (EDSS) / Functional Systems Score (FSS),
* Fatigue severity scale and Modified Fatigue Impact Scale. before the exercise program and after finishing the exercise program, The assessor of the patients, before and after the program, will be blinded to the technique used (whether active or sham).
The evaluation methods will be done using:
* Expanded Disability Status Scale (EDSS) / Functional Systems Score (FSS),
* Fatigue severity scale and Modified Fatigue Impact Scale. before the exercise program and after finishing the exercise program, The assessor of the patients, before and after the program, will be blinded to the technique used (whether active or sham).
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?: