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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: High Tone Power Therapy
* Other: exercise program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>in the active arm patients will receive high tone power therapy in addition to the physical therapy conventional selected exercise program | Device: High Tone Power Therapy<br>* High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany). The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort.<br>Other: exercise program<br>* physical therapy conventional selected exercise program inform of functional activities of daily living<br>|
| Sham Comparator: control group<br>the sham arm will receive the same physical exercise program with sham high tone power therapy. | Other: exercise program<br>* physical therapy conventional selected exercise program inform of functional activities of daily living<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expanded Disability Status Scale (EDSS) | 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 | 4 weeks | 
| Functional Systems Score (FSS), | 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Tone Power Therapy, fatigue, functional outcomes