Diabetic Peripheral NeuropathyNCT04555876
Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease
A study testing high tone external muscle stimulation- stationary bicycle in people with Diabetic Peripheral Neuropathy, run by Cairo University.
Trial summary
to investigate the effect of high tone external muscle stimulation (HTEMS) on endothelial dysfunction and walking parameters in peripheral vascular disease. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- high tone external muscle stimulation- stationary bicycle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Feb 2021
- 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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1- Both genders are allowed to participate in the study. 2- The age range of patients will be from 50-60 years 3- All patients are diabetic from 5-7 years. 4- ABPI for all patients will be ranged from 0.65 to 0. 9 5- All patients are medically and psychologically stable. 6- Only ambulant patient without any aids will be selected 7- All patients are non smokers.
Who cannot join
- Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 )
- Patients who are unable to walk on treadmill or unable to attend sessions at the physical therapy department at Cairo university hospitals, 3 times a week.
- Patients with unstable cardiovascular conditions (those with a known history of recent myocardial infarction, uncontrolled hypertension, ischemic attacks, stroke, and congestive heart failure) will be excluded from this study.
- Patients with neurological problems that cause leg pain and polyneuropathy.
- Patients with active malignancy will be excluded from study
- Patients with ischemic ulcers or gangrenes
Show all 9Show fewer
- Patients with a vascular surgical procedure or angioplasty within the previous year will be excluded from the study
- Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis, severe osteoarthritis or joint replacement).
- -
About this study
Official title: High Tone External Muscle Stimulation On Endothelial Dysfunction And Walking Parameters In Peripheral Arterial Disease
to investigate the effect of high tone external muscle stimulation (HTEMS) on endothelial dysfunction and walking parameters in peripheral vascular disease.
Read the detailed description
The patients will randomly be divided into two equal groups in number:
- Group A : Thirty patients will participate in physical therapy program in form of high-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks plus supervised regular aerobic exercise program on stationary bicycle with moderate intensity, ( score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks .
- Group B:
Thirty patients will participate in a supervised regular aerobic exercise program only on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- high tone external muscle stimulation- stationary bicycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tone external muscle stimulation- stationary bicycleDevice
Also called stationary bicycle
high-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| high tone external muscle stimulation | Experimental | - HiTop 191 appliance (gbo Medizintechnik AG, Rimbach, Germany) Device HiToP® 4 touch gbo Medizintechnik AG, this modern high-tech design with brushed aluminum surface and the 15" TFT LC D full color touch screen monitor offer to the health care professional an indispensable feature. Receives: Device: high tone external muscle stimulation- stationary bicycle |
| stationary bicycle | Experimental | supervised regular aerobic exercise program on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks. Receives: Device: high tone external muscle stimulation- stationary bicycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring walking time in minutes
maximum walking time the patient can walk in minutes without complain
Measured: 10 weeks
measuring walking distance in meter
maximum walking distance the patient can walk in meter
Measured: 10 weeks
Secondary outcomes (1)
Measuring serum Nitric Oxide
Three millimeter of venous blood will be drawn from the anticubital vein of each patient before conduction and after completion of the study. Blood sample will be drawn for Nitric Oxide (NO) measurement.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will randomly be divided into two equal groups in number: 1. Group A : Thirty patients will participate in physical therapy program in form of high-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks plus supervised regular aerobic exercise program on stationary bicycle with moderate intensity, ( score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks . 2. Group B: Thirty patients will participate in a supervised regular aerobic exercise program only on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Abdel Baset, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555876
- Sponsor's protocol ID
- P.T.REC/012/002173
- Status last verified
- Sep 2020
- First submitted
- 8 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Tone External Muscle Stimulation On Endothelial Dysfunction And Walking Parameters In Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT04555876
- Acronym / sponsor ID
- P.T.REC/012/002173
- Conditions
- Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 21 Sep 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 external muscle stimulation (HTEMS) on endothelial dysfunction and walking parameters in peripheral vascular disease.
Detailed description
The patients will randomly be divided into two equal groups in number:
- Group A : Thirty patients will participate in physical therapy program in form of high-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks plus supervised regular aerobic exercise program on stationary bicycle with moderate intensity, ( score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks .
- Group B:
Thirty patients will participate in a supervised regular aerobic exercise program only on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients will randomly be divided into two equal groups in number: 1. Group A : Thirty patients will participate in physical therapy program in form of high-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks plus supervised regular aerobic exercise program on stationary bicycle with moderate intensity, ( score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks . 2. Group B: Thirty patients will participate in a supervised regular aerobic exercise program only on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks.
| Arm | Type | Receives |
|---|---|---|
| high tone external muscle stimulation | Experimental | Device: high tone external muscle stimulation- stationary bicycle- HiTop 191 appliance (gbo Medizintechnik AG, Rimbach, Germany) Device HiToP® 4 touch gbo Medizintechnik AG, this modern high-tech design with brushed aluminum surface and the 15" TFT LC D full color touch screen monitor offer to the health care professional an indispensable feature. |
| stationary bicycle | Experimental | Device: high tone external muscle stimulation- stationary bicyclesupervised regular aerobic exercise program on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1- Both genders are allowed to participate in the study. 2- The age range of patients will be from 50-60 years 3- All patients are diabetic from 5-7 years. 4- ABPI for all patients will be ranged from 0.65 to 0. 9 5- All patients are medically and psychologically stable. 6- Only ambulant patient without any aids will be selected 7- All patients are non smokers.
Key exclusion criteria (9 listed)
- Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 )
- Patients who are unable to walk on treadmill or unable to attend sessions at the physical therapy department at Cairo university hospitals, 3 times a week.
- Patients with unstable cardiovascular conditions (those with a known history of recent myocardial infarction, uncontrolled hypertension, ischemic attacks, stroke, and congestive heart failure) will be excluded from this study.
- Patients with neurological problems that cause leg pain and polyneuropathy.
- Patients with active malignancy will be excluded from study
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 external muscle stimulation- stationary bicycleAlso: stationary bicyclehigh-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks | Device | high tone external muscle stimulation, stationary bicycle |
Primary outcome
measuring walking time in minutes
Time frame: 10 weeks
maximum walking time the patient can walk in minutes without complain
measuring walking distance in meter
Time frame: 10 weeks
maximum walking distance the patient can walk in meter
1 secondary outcome
Measuring serum Nitric Oxide
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing high tone external muscle stimulation- stationary bicycle in people with Diabetic Peripheral Neuropathy, run by Cairo University.
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 1 inclusion and 9 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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
measuring walking time in minutes (time frame: 10 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 21 Sep 2020.