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

NCT ID: NCT04530669

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2020-12-30

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).

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program

Group Type: EXPERIMENTAL

High Tone Power Therapy

Intervention Type: 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

Intervention Type: OTHER

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

control group

the sham arm will receive the same physical exercise program with sham "high tone power therapy".

Group Type: SHAM_COMPARATOR

exercise program

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

exercise program

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lama Saad El-Din Mahmoud

OTHER

Sponsor Role: lead

Responsible Party

Lama Saad El-Din Mahmoud

Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lama S Mahmoud

Role: STUDY_DIRECTOR

Cairo University

Khalid T Turky, PHD

Role: STUDY_CHAIR

Ph.D., Assist. prof : Physical Therapy

Nevin M Shalaby, PHD

Role: STUDY_DIRECTOR

Professor of neurology Department of Neurology , Faculty of Medicine, Cairo University.

Locations

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

Al Jīzah, Select State, Egypt

Countries

Egypt

Other Identifiers

P.T. REC/012/002866

Identifier Type: -

Identifier Source: org_study_id