Diabetic NeuropathiesNCT05790421
Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy
A study testing Foot Muscle Energy Technique and Conventional Physical Therapy Program in people with Diabetic Neuropathies, run by October 6 University at 1 site in Egypt.
Trial summary
Foot muscle energy technique and conventional physical therapy program administered in patients with type 2 Diabetic Neuropathy. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Foot Muscle Energy Technique and Conventional Physical Therapy Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Apr 2022to 3 Jan 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants (males and females) examined with non-insulin-dependent diabetes for ≥10 years determined by neurophysiological measurements were enrolled.
- The participants regularly took their diabetes medications during the assessment and treatment period.
- The use of any sedatives or anticonvulsants was contraindicated for all participants.
Who cannot join
- Uncontrolled non-insulin dependent diabetes and diagnosed for < 10 years, neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy: A Randomized Controlled Trial
Foot muscle energy technique and conventional physical therapy program administered in patients with type 2 Diabetic Neuropathy.
Read the detailed description
Foot muscle energy technique and conventional physical therapy program administered in patients with type 2 Diabetic Neuropathy.
- Conditions
- Diabetic Neuropathies
- Being tested
- Foot Muscle Energy Technique, Conventional Physical Therapy Program
- Keywords
- Diabetic neuropathy, Foot muscle energy technique, Isometric muscle strength, Motor nerve conduction velocity study
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Muscle Energy TechniqueOther
Also called Foot MET
Starting from the preparation position, at the restriction barrier, the patient is asked to exert a small effort (no more than 20% of available strength) towards plantarflexion, against unyielding resistance, with appropriate breathing. The patient produces isometric effort contracts either gastrocnemius or soleus (depending on whether the knee is unflexed or flexed). This contraction is held for 7-10 seconds together with a held breath. The exercise was repeated until the full range of movement was obtained.
Conventional Physical Therapy ProgramOther
Graduated active resisted range of motion exercises for both UL and LL and graduated gait training
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants received foot muscle energy techniques and conventional physical therapy program for three sessions/week for 4 weeks, each lasting 30 min Receives: Other: Foot Muscle Energy Technique; Other: Conventional Physical Therapy Program |
| Group B | Experimental | Participants received conventional physical therapy program only for three sessions/week for 4 weeks, each lasting 30 min Receives: Other: Conventional Physical Therapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor nerve conduction study
Assess both tibial and deep peroneal motor nerve conduction velocity.
Measured: 4 weeks
Toe Strength Dynamometer
Assess Isometric muscle strength.
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 posted30 Mar 2023
- Study start2 Apr 2022
- Primary completion6 Nov 2022
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Magdy Alshimy, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790421
- Sponsor's protocol ID
- REC/2111/MTI.PT/2204061
- Status last verified
- Jun 2023
- First submitted
- 6 Mar 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05790421
- Acronym / sponsor ID
- REC/2111/MTI.PT/2204061
- Conditions
- Diabetic Neuropathies
- Keywords
- Diabetic neuropathy, Foot muscle energy technique, Isometric muscle strength, Motor nerve conduction velocity study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 30 Mar 2023 (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.
Foot muscle energy technique and conventional physical therapy program administered in patients with type 2 Diabetic Neuropathy.
Detailed description
Foot muscle energy technique and conventional physical therapy program administered in patients with type 2 Diabetic Neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Foot Muscle Energy Technique, Other: Conventional Physical Therapy ProgramParticipants received foot muscle energy techniques and conventional physical therapy program for three sessions/week for 4 weeks, each lasting 30 min |
| Group B | Experimental | Other: Conventional Physical Therapy ProgramParticipants received conventional physical therapy program only for three sessions/week for 4 weeks, each lasting 30 min |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants (males and females) examined with non-insulin-dependent diabetes for ≥10 years determined by neurophysiological measurements were enrolled.
- The participants regularly took their diabetes medications during the assessment and treatment period.
- The use of any sedatives or anticonvulsants was contraindicated for all participants.
Key exclusion criteria (1 listed)
- Uncontrolled non-insulin dependent diabetes and diagnosed for < 10 years, neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.
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 |
|---|---|---|
| Foot Muscle Energy TechniqueAlso: Foot METStarting from the preparation position, at the restriction barrier, the patient is asked to exert a small effort (no more than 20% of available strength) towards plantarflexion, against unyielding resistance, with appropriate breathing. The patient produces isometric effort contracts either gastrocnemius or soleus (depending on whether the knee is unflexed or flexed). This contraction is held for 7-10 seconds together with a held breath. The exercise was repeated until the full range of movement was obtained. | Other | Group A |
| Conventional Physical Therapy ProgramGraduated active resisted range of motion exercises for both UL and LL and graduated gait training | Other | Group A, Group B |
Primary outcome
Motor nerve conduction study
Time frame: 4 weeks
Assess both tibial and deep peroneal motor nerve conduction velocity.
Toe Strength Dynamometer
Time frame: 4 weeks
Assess Isometric muscle strength.
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 15 Jun 2023.
- Individual participant dataSharing planned: No
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Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
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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 Foot Muscle Energy Technique and Conventional Physical Therapy Program in people with Diabetic Neuropathies, 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 3 inclusion and 1 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 15 Jun 2023. 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?
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?
Motor nerve conduction study (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 15 Jun 2023.