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?

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: High Tone Power Therapy; Other: exercise program

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; 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; 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.; Other: exercise program; physical therapy conventional selected exercise program inform of functional activities of daily living
Sham Comparator: control group; the sham arm will receive the same physical exercise program with sham "high tone power therapy".	Other: exercise program; physical therapy conventional selected exercise program inform of functional activities of daily living

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lama Saad El-Din Mahmoud
• Investigators: Study Director: Lama S Mahmoud, Cairo University; Study Chair: Khalid T Turky, PHD, Ph.D., Assist. prof : Physical Therapy; Study Director: Nevin M Shalaby, PHD, Professor of neurology Department of Neurology , Faculty of Medicine, Cairo University.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): December 30, 2020

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): July 13, 2021
• Last Update Submitted That Met QC Criteria: July 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: fatigue; functional outcomes; High Tone Power Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue
• Other Study ID Numbers: P.T. REC/012/002866

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No