RehabilitationWHONCT05217771
Effect Of High Tone Power Therapy On Selected Symptoms In Post Covid Syndrome
A study testing High tone power therapy group in people with Rehabilitation, run by October 6 University at 1 site in Egypt.
Trial summary
The Coronavirus Disease 2019 (COVID-19) is a highly transmittable and pathogenic viral infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2), which emerged in Wuhan, China in December 2019 and its spread around the world has been rapid (Rathi et al., 2021; Vakili et al., 2021). Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- High tone power therapy group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2021to 20 Nov 2022
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All patients were diagnosed with COVID-19 by polymerase chain reaction (PCR) test of a nasopharyngeal sample during acute phase, completed CBC, lymphocyte inflammatory marker, c-reactive protein and ESR.
- Patients must be negative polymerase chain reaction (PCR).
- Patients will be completely recovered from acute symptoms of covid-19.
- Patients will be recruited after 2- 4 weeks post complete recovery from acute symptoms
Who cannot join
- • Patients with feverish systemic or local bacterial infections.
- Epilepsy.
- Pregnant women patients.
- Cancer.
- Uncontrolled Diabetes milletus >250 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
The Coronavirus Disease 2019 (COVID-19) is a highly transmittable and pathogenic viral infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2), which emerged in Wuhan, China in December 2019 and its spread around the world has been rapid (Rathi et al., 2021; Vakili et al., 2021). COVID-19 impacts on economy, society, education , neurological, psychiatric and psychosocial impairments , increasing the burden of disease and disability throughout the world have been studied by several authors (Phillips et al., 2020; Pragholapati, 2020).
COVID-19 may lead to greater risks of long-term scarring, permanently lower economic activity, a significant increase in the prevalence of chronic illness, social distancing, isolation, changes in teaching and learning strategies to decrease of number of days of education, the number of social contacts each day is limited (Minister \& Majesty, 2020; Almomani et al., 2021) .
Read the detailed description
The Coronavirus Disease 2019 (COVID-19) is a highly transmittable and pathogenic viral infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2), which emerged in Wuhan, China in December 2019 and its spread around the world has been rapid (Rathi et al., 2021; Vakili et al., 2021). COVID-19 impacts on economy, society, education , neurological, psychiatric and psychosocial impairments , increasing the burden of disease and disability throughout the world have been studied by several authors (Phillips et al., 2020; Pragholapati, 2020).
COVID-19 may lead to greater risks of long-term scarring, permanently lower economic activity, a significant increase in the prevalence of chronic illness, social distancing, isolation, changes in teaching and learning strategies to decrease of number of days of education, the number of social contacts each day is limited (Almomani et al., 2021; Minister \& Majesty, 2020) .
Thus, multi-organ injuries are observed in COVID-19, such as acute respiratory distress syndrome, acute myocardial injury, acute kidney injury, and acute liver injury. Survivors of severe COVID-19 are also found to be with multi-organ impairments after discharge (Dennis et al., 2021)
Clinical presentation of COVID- I9 ranges from absence of symptoms to severe pneumonia while fever, dry cough and fatigue, dyspnea, myalgia, arthralgia, distress, anxiety, and depression are common symptoms. The uncommon symptoms include sputum production, headache, hemoptysis, nausea, vomiting and diarrhea among COVID-19 patients (Feng et al., 2020).
Different Phases of COVID-19 defining acute COVID-19 or transition phase: (signs and symptoms of COVID-19 for up to 4 weeks), Acute post COVID symptoms: (signs and symptoms of COVID-19 from 4 to 12 weeks), and long post-COVID-19 syndrome (signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks up to 24 weeks and are not explained by an alternative diagnosis). persistent post COVID symptoms: symptoms lasting more than 24 weeks (Fernández-de-las-Peñas et al., 2021; Yong, 2021a).
The persisted symptoms of post COVID-19 syndrome are correlated with the severity of illness during acute phase. The illness severity pattern could be categorized as follow; asymptomatic infected patients, symptomatic patients isolating at home, symptomatic patients admitted to hospital, and symptomatic patients requiring ventilatory support in critical care which can lead to permanent sequelae and even death (Castroa et al., 2021).
Persistent post-COVID syndrome (PPCS) or long COVID is a pathologic entity, which involves persistent physical, medical, and cognitive sequelae following COVID-19 as symptoms at least one symptom persists for more than three months after the first symptom onset up to six months. Patients who were no longer positive for SARS-CoV-2 and discharged from the hospital, as well as outpatients, can also develop long COVID (Oronsky et al., 2021).
COVID-19 is a multisystem disease, which in certain cases will require full multidisciplinary team (MDT) rehabilitation required many specialties to enable recovery. The British Society of Rehabilitation Medicine (BSRM) have recently published a position statement that includes the rehabilitation care pathways and coordinated networks that will be required following the COVID-19 pandemic (Barker-Davies et al., 2020).
Rehabilitation may work for treating certain cases of post COVID. There are existing rehabilitation pathways that assess and manage the rehabilitation needs of patients with long-term conditions, notably, cardiac, and pulmonary rehabilitation pathways. These services accommodate patients with multiple comorbidities, including chronic respiratory disease, and cardiovascular, mental health and metabolic diseases. Reviews have also recommended that rehabilitation programs be personalized since post COVID manifestation and pathophysiology may vary in each case (Singh et al., 2020).
High tone power therapy (HiTop) is a new quantum leap in the field of electro therapy without muscle and nerve stimulation. It is electrotherapy with sinusoidal alternating currents. The high tone power therapy provides a therapy with medium frequency sine waves. The therapy is free of direct current (D.C.) components. The amplitude and the frequency are modulated simultaneously. The higher the frequency, the more energy can be introduced corresponding to the individual threshold curve of the patient's electro sensitivity (Medizintechnik, 2008).
High Tone power therapy is increase mitochondria in number and size. The differences in effect relate to two main mechanisms of High Tone power therapy: First, it introduces energy into the body to increase the cell energy potential, to activate cells, to revitalize the body, producing a resonance effect that creates an oscillation or vibration in the cells and tissues. Second, it makes the cell structures oscillate to normalize the metabolism, scattering the mediators of inflammation, nutrients, and waste substances (Requena et al., 2005). so that high tone will be treat persisted symptoms of covid-19.
- Conditions
- Rehabilitation
- Being tested
- High tone power therapy group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tone power therapy groupOther
patients in this group will receive High tone power therapy from 30 to 60 minutes, 3 session /week for 4 weeks with total sessions at least l0 sessions and self-stretch for hand and shoulder.
| Study group | Role | What they receive |
|---|---|---|
| High tone power therapy group | Experimental | patients in this group will receive High tone power therapy from 30 to 60 minutes, 3 session /week for 4 weeks with total sessions at least l0 sessions and self-stretch for hand and shoulder. Receives: Other: High tone power therapy group |
| control group | Experimental | Patients in control group will receive high tone sham therapy 3 times per week and self-stretch for hand and shoulder. Receives: Other: High tone power therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-Minute Walk Test
for functional capacity
Measured: 4 weeks
Chalder Fatigue Scale: score can range from 0 to 33, with a higher score indicating greater fatigue.
for chronic Fatigue
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 posted1 Feb 2022
- Study start10 Nov 2021
- Primary completion20 Nov 2022 (estimated)
- Study completion20 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Kadry, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217771
- Sponsor's protocol ID
- 8976
- Acronym
- WHO
- Status last verified
- Jan 2022
- First submitted
- 24 Jan 2022
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of High Tone Power Therapy On Selected Symptoms In Post Covid Syndrome
- ClinicalTrials.gov ID
- NCT05217771
- Acronym / sponsor ID
- WHO / 8976
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 20 Nov 2022 (estimated)
- First posted
- 1 Feb 2022 (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.
The Coronavirus Disease 2019 (COVID-19) is a highly transmittable and pathogenic viral infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2), which emerged in Wuhan, China in December 2019 and its spread around the world has been rapid (Rathi et al., 2021; Vakili et al., 2021). COVID-19 impacts on economy, society, education , neurological, psychiatric and psychosocial impairments , increasing the burden of disease and disability throughout the world have been studied by several authors (Phillips et al., 2020; Pragholapati, 2020).
COVID-19 may lead to greater risks of long-term scarring, permanently lower economic activity, a significant increase in the prevalence of chronic illness, social distancing, isolation, changes in teaching and learning strategies to decrease of number of days of education, the number of social contacts each day is limited (Minister \& Majesty, 2020; Almomani et al., 2021) .
Detailed description
The Coronavirus Disease 2019 (COVID-19) is a highly transmittable and pathogenic viral infection caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2), which emerged in Wuhan, China in December 2019 and its spread around the world has been rapid (Rathi et al., 2021; Vakili et al., 2021). COVID-19 impacts on economy, society, education , neurological, psychiatric and psychosocial impairments , increasing the burden of disease and disability throughout the world have been studied by several authors (Phillips et al., 2020; Pragholapati, 2020).
COVID-19 may lead to greater risks of long-term scarring, permanently lower economic activity, a significant increase in the prevalence of chronic illness, social distancing, isolation, changes in teaching and learning strategies to decrease of number of days of education, the number of social contacts each day is limited (Almomani et al., 2021; Minister \& Majesty, 2020) .
Thus, multi-organ injuries are observed in COVID-19, such as acute respiratory distress syndrome, acute myocardial injury, acute kidney injury, and acute liver injury. Survivors of severe COVID-19 are also found to be with multi-organ impairments after discharge (Dennis et al., 2021)
Clinical presentation of COVID- I9 ranges from absence of symptoms to severe pneumonia while fever, dry cough and fatigue, dyspnea, myalgia, arthralgia, distress, anxiety, and depression are common symptoms. The uncommon symptoms include sputum production, headache, hemoptysis, nausea, vomiting and diarrhea among COVID-19 patients (Feng et al., 2020).
Different Phases of COVID-19 defining acute COVID-19 or transition phase: (signs and symptoms of COVID-19 for up to 4 weeks), Acute post COVID symptoms: (signs and symptoms of COVID-19 from 4 to 12 weeks), and long post-COVID-19 syndrome (signs and symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks up to 24 weeks and are not explained by an alternative diagnosis). persistent post COVID symptoms: symptoms lasting more than 24 weeks (Fernández-de-las-Peñas et al., 2021; Yong, 2021a).
The persisted symptoms of post COVID-19 syndrome are correlated with the severity of illness during acute phase. The illness severity pattern could be categorized as follow; asymptomatic infected patients, symptomatic patients isolating at home, symptomatic patients admitted to hospital, and symptomatic patients requiring ventilatory support in critical care which can lead to permanent sequelae and even death (Castroa et al., 2021).
Persistent post-COVID syndrome (PPCS) or long COVID is a pathologic entity, which involves persistent physical, medical, and cognitive sequelae following COVID-19 as symptoms at least one symptom persists for more than three months after the first symptom onset up to six months. Patients who were no longer positive for SARS-CoV-2 and discharged from the hospital, as well as outpatients, can also develop long COVID (Oronsky et al., 2021).
COVID-19 is a multisystem disease, which in certain cases will require full multidisciplinary team (MDT) rehabilitation required many specialties to enable recovery. The British Society of Rehabilitation Medicine (BSRM) have recently published a position statement that includes the rehabilitation care pathways and coordinated networks that will be required following the COVID-19 pandemic (Barker-Davies et al., 2020).
Rehabilitation may work for treating certain cases of post COVID. There are existing rehabilitation pathways that assess and manage the rehabilitation needs of patients with long-term conditions, notably, cardiac, and pulmonary rehabilitation pathways. These services accommodate patients with multiple comorbidities, including chronic respiratory disease, and cardiovascular, mental health and metabolic diseases. Reviews have also recommended that rehabilitation programs be personalized since post COVID manifestation and pathophysiology may vary in each case (Singh et al., 2020).
High tone power therapy (HiTop) is a new quantum leap in the field of electro therapy without muscle and nerve stimulation. It is electrotherapy with sinusoidal alternating currents. The high tone power therapy provides a therapy with medium frequency sine waves. The therapy is free of direct current (D.C.) components. The amplitude and the frequency are modulated simultaneously. The higher the frequency, the more energy can be introduced corresponding to the individual threshold curve of the patient's electro sensitivity (Medizintechnik, 2008).
High Tone power therapy is increase mitochondria in number and size. The differences in effect relate to two main mechanisms of High Tone power therapy: First, it introduces energy into the body to increase the cell energy potential, to activate cells, to revitalize the body, producing a resonance effect that creates an oscillation or vibration in the cells and tissues. Second, it makes the cell structures oscillate to normalize the metabolism, scattering the mediators of inflammation, nutrients, and waste substances (Requena et al., 2005). so that high tone will be treat persisted symptoms of covid-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High tone power therapy group | Experimental | Other: High tone power therapy grouppatients in this group will receive High tone power therapy from 30 to 60 minutes, 3 session /week for 4 weeks with total sessions at least l0 sessions and self-stretch for hand and shoulder. |
| control group | Experimental | Other: High tone power therapy groupPatients in control group will receive high tone sham therapy 3 times per week and self-stretch for hand and shoulder. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All patients were diagnosed with COVID-19 by polymerase chain reaction (PCR) test of a nasopharyngeal sample during acute phase, completed CBC, lymphocyte inflammatory marker, c-reactive protein and ESR.
- Patients must be negative polymerase chain reaction (PCR).
- Patients will be completely recovered from acute symptoms of covid-19.
- Patients will be recruited after 2- 4 weeks post complete recovery from acute symptoms
Key exclusion criteria (5 listed)
- • Patients with feverish systemic or local bacterial infections.
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 therapy grouppatients in this group will receive High tone power therapy from 30 to 60 minutes, 3 session /week for 4 weeks with total sessions at least l0 sessions and self-stretch for hand and shoulder. | Other | High tone power therapy group, control group |
Primary outcome
Six-Minute Walk Test
Time frame: 4 weeks
for functional capacity
Chalder Fatigue Scale: score can range from 0 to 33, with a higher score indicating greater fatigue.
Time frame: 4 weeks
for chronic Fatigue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 group in people with Rehabilitation, run by October 6 University 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 4 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. 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. 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?
Results are not available in the source record.
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?
Six-Minute Walk Test (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 1 Feb 2022.