Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease

NCT ID: NCT04555876

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-02-01

Brief Summary

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:

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.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

high tone external muscle stimulation

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Group Type: EXPERIMENTAL

high tone external muscle stimulation- stationary bicycle

Intervention Type: DEVICE

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

stationary bicycle

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 Type: EXPERIMENTAL

high tone external muscle stimulation- stationary bicycle

Intervention Type: DEVICE

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

Interventions

high tone external muscle stimulation- 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

Intervention Type: DEVICE

Other Intervention Names

stationary bicycle

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

1. Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 )

2. 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.

3. 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.

4. Patients with neurological problems that cause leg pain and polyneuropathy.

5. Patients with active malignancy will be excluded from study

6. Patients with ischemic ulcers or gangrenes

7. Patients with a vascular surgical procedure or angioplasty within the previous year will be excluded from the study

8. Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis, severe osteoarthritis or joint replacement).

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• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Rania Abdel Baset

principle invistigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

P.T.REC/012/002173

Identifier Type: -

Identifier Source: org_study_id