Back to resultsEffect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathies
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Foot Muscle Energy Technique
Conventional Physical Therapy Program
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Diabetic neuropathy, Foot muscle energy technique, Isometric muscle strength, Motor nerve conduction velocity study
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: • Uncontrolled non-insulin dependent diabetes and diagnosed for < 10 years, neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.
Sites / Locations
- October 6 University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
Participants received foot muscle energy techniques and conventional physical therapy program for three sessions/week for 4 weeks, each lasting 30 min
Participants received conventional physical therapy program only for three sessions/week for 4 weeks, each lasting 30 min
Outcomes
Primary Outcome Measures
Motor nerve conduction study
Assess both tibial and deep peroneal motor nerve conduction velocity.
Toe Strength Dynamometer
Assess Isometric muscle strength.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05790421
Brief Title
Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy
Official Title
Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 2, 2022 (Actual)
Primary Completion Date
November 6, 2022 (Actual)
Study Completion Date
January 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
Diabetic neuropathy, Foot muscle energy technique, Isometric muscle strength, Motor nerve conduction velocity study
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Participants received foot muscle energy techniques and conventional physical therapy program for three sessions/week for 4 weeks, each lasting 30 min
Arm Title
Group B
Arm Type
Experimental
Arm Description
Participants received conventional physical therapy program only for three sessions/week for 4 weeks, each lasting 30 min
Intervention Type
Other
Intervention Name(s)
Foot Muscle Energy Technique
Other Intervention Name(s)
Foot MET
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy Program
Intervention Description
Graduated active resisted range of motion exercises for both UL and LL and graduated gait training
Primary Outcome Measure Information:
Title
Motor nerve conduction study
Description
Assess both tibial and deep peroneal motor nerve conduction velocity.
Time Frame
4 weeks
Title
Toe Strength Dynamometer
Description
Assess Isometric muscle strength.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
• Uncontrolled non-insulin dependent diabetes and diagnosed for < 10 years, neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.
Facility Information:
Facility Name
October 6 University
City
El-Sheikh Zayed City
State/Province
Giza
ZIP/Postal Code
1133
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy
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