The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: High Tone Power Therapy; Other: exercise program

• Registration Number: NCT04530669
• Lead Sponsor: Lama Saad El-Din Mahmoud

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).

Study Timeline

• Study First Submitted: 2020-08-25
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-28
• Study Start: 2020-09-01
• Primary Completion: 2020-10-15
• Study Completion: 2020-12-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-11
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	High Tone Power Therapy	in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program
study group	exercise program	in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program
control group	exercise program	the sham arm will receive the same physical exercise program with sham "high tone power therapy".

Primary Outcome Measures

Name	Time	Method
Expanded Disability Status Scale (EDSS)	4 weeks	The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.; The scale was developed by a neurologist called John Kurtzke in 1983 as an advance from his previous 10 step Disability Status Scale (DSS).; The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.; EDSS steps 1.0 to 4.5 refer to people with MS who are able to walk without any aid and is based on measures of impairment in eight functional systems
Functional Systems Score (FSS),	4 weeks	On a scale of 0 to 6, the functional system score (FSS) measures how well the major central nervous systems are working and assigns a score to the patient disability. This score uses also information about the gait and use of assistive devices.

Trial Locations

Locations (1)

Kasr Al-Ainy MS clinic, Neurology department, Cairo University hospitals.; 🇪🇬 Al Jīzah, Select State, Egypt