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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High Tone Power Therapy
exercise program
Sponsored by
Lama Saad El-Din Mahmoud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring High Tone Power Therapy, fatigue, functional outcomes

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

study group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2020
Last Updated
July 11, 2021
Sponsor
Lama Saad El-Din Mahmoud
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1. Study Identification

Unique Protocol Identification Number
NCT04530669
Brief Title
The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
Official Title
The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
October 15, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lama Saad El-Din Mahmoud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
High Tone Power Therapy, fatigue, functional outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
the sham arm will receive the same physical exercise program with sham "high tone power therapy".
Intervention Type
Device
Intervention Name(s)
High Tone Power Therapy
Intervention Description
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
Other
Intervention Name(s)
exercise program
Intervention Description
physical therapy conventional selected exercise program inform of functional activities of daily living
Primary Outcome Measure Information:
Title
Expanded Disability Status Scale (EDSS)
Description
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
Time Frame
4 weeks
Title
Functional Systems Score (FSS),
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lama S Mahmoud
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Khalid T Turky, PHD
Organizational Affiliation
Ph.D., Assist. prof : Physical Therapy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nevin M Shalaby, PHD
Organizational Affiliation
Professor of neurology Department of Neurology , Faculty of Medicine, Cairo University.
Official's Role
Study Director
Facility Information:
Facility Name
Kasr Al-Ainy MS clinic, Neurology department, Cairo University hospitals.
City
Al Jīzah
State/Province
Select State
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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