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Completed

NCT Number: NCT04530669

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

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?

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Al-Ainy MS clinic, Neurology department, Cairo University hospitals.

Al Jīzah, Select State, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Tone Power Therapy

Device

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.

exercise program

Other

physical therapy conventional selected exercise program inform of functional activities of daily living

Primary outcomes

  1. Expanded Disability Status Scale (EDSS)

    Time frame: 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

  2. Functional Systems Score (FSS),

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lama Saad El-Din Mahmoud

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 28, 2020
Registry last updated
Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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