Multiple SclerosisNCT04530669
The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
A study testing High Tone Power Therapy and exercise program in people with Multiple Sclerosis, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- High Tone Power Therapy and exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr Al-Ainy MS clinic, Neurology department, Cairo University hospitals.
Al Jīzah, Select State
About this study
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?
Read the 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
- Being tested
- High Tone Power Therapy, exercise program
- Keywords
- High Tone Power Therapy, fatigue, functional outcomes
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Tone Power TherapyDevice
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 programOther
physical therapy conventional selected exercise program inform of functional activities of daily living
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | in the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program Receives: Device: High Tone Power Therapy; Other: exercise program |
| control group | Sham comparator | the sham arm will receive the same physical exercise program with sham "high tone power therapy". Receives: Other: exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Sep 2020
- Primary completion15 Oct 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lama Saad El-Din Mahmoud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lama Saad El-Din Mahmoud, October 6 University
- Investigators
- Lama S Mahmoud, Study director, Cairo UniversityKhalid T Turky, PHD, Study chair, Ph.D., Assist. prof : Physical TherapyNevin M Shalaby, PHD, Study director, Professor of neurology Department of Neurology , Faculty of Medicine, Cairo University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530669
- Sponsor's protocol ID
- P.T. REC/012/002866
- Status last verified
- Jul 2021
- First submitted
- 25 Aug 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Tone Power Therapy on Fatigue and Functional Outcomes in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04530669
- Acronym / sponsor ID
- P.T. REC/012/002866
- Conditions
- Multiple Sclerosis
- Keywords
- High Tone Power Therapy, fatigue, functional outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Lama Saad El-Din MahmoudUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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".
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: High Tone Power Therapy, Other: exercise programin the active arm patients will receive "high tone power therapy" in addition to the physical therapy conventional selected exercise program |
| control group | Sham comparator | Other: exercise programthe sham arm will receive the same physical exercise program with sham "high tone power therapy". |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Tone Power TherapyHigh 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. | Device | study group |
| exercise programphysical therapy conventional selected exercise program inform of functional activities of daily living | Other | control group, study group |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lama S Mahmoud study director
Cairo University
Khalid T Turky, PHD study chair
Ph.D., Assist. prof : Physical Therapy
Nevin M Shalaby, PHD study director
Professor of neurology Department of Neurology , Faculty of Medicine, Cairo University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Tone Power Therapy and exercise program in people with Multiple Sclerosis, run by Lama Saad El-Din Mahmoud at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expanded Disability Status Scale (EDSS) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.