Clinical trial NCT04530669: The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
Official title: The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: High Tone Power Therapy
fatigue
functional outcomes
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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".
Primary purpose: TREATMENT

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?

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).

Eligibility criteria: Inclusion Criteria:

- Both genders

* Age from 18-50 years
* All MS types will be included (relapsing remitting "RR", secondary progressive "SP, and primary progressive "PP")
* Patients with residual motor / cerebellar / sphincteric impairment that are not responding to conventional pharmacological treatments.
* At least 6 months after the last relapse.
* EDSS from 2-6.5.
* All patients should be receiving a disease modifying therapy with stabilization of the disease course for 1 year in case of SPMS and PPMS.
* Patients that can pay regular visits to the physical center without potential interruption.
* Patients who agree to participate and sign the informed consent. - body mass index (20:29) kg/m2

Exclusion Criteria:

* cognitive impairment that can hinder the ability to communicate or to understand program instructions.
* neurological deficits due to any disease other than MS
* orthopedic abnormalities,
* secondary musculoskeletal complication.
* Patients who refuse participation or signing the informed consent.

Primary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: 4 weeks
measure: Functional Systems Score (FSS),
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Kasr Al-Ainy MS clinic, Neurology department, Cairo University hospitals.
state: Select State
Study officials:
affiliation: Cairo University
name: Lama S Mahmoud
role: STUDY_DIRECTOR
affiliation: Ph.D., Assist. prof : Physical Therapy
name: Khalid T Turky, PHD
role: STUDY_CHAIR
affiliation: Professor of neurology Department of Neurology , Faculty of Medicine, Cairo University.
name: Nevin M Shalaby, PHD
role: STUDY_DIRECTOR
References: