Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathies
• Intervention / Treatment: Other: Foot Muscle Energy Technique; Other: Conventional Physical Therapy Program

Detailed Description

Foot muscle energy technique and conventional physical therapy program administered in patients with type 2 Diabetic Neuropathy.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • El-Sheikh Zayed City, Giza, Egypt, 1133
      • October 6 University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Participants received foot muscle energy techniques and conventional physical therapy program for three sessions/week for 4 weeks, each lasting 30 min	Other: Foot Muscle Energy Technique; 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.; Other Names: Foot MET; Other: Conventional Physical Therapy Program; Graduated active resisted range of motion exercises for both UL and LL and graduated gait training
Experimental: Group B; Participants received conventional physical therapy program only for three sessions/week for 4 weeks, each lasting 30 min	Other: Conventional Physical Therapy Program; Graduated active resisted range of motion exercises for both UL and LL and graduated gait training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor nerve conduction study	Assess both tibial and deep peroneal motor nerve conduction velocity.	4 weeks
Toe Strength Dynamometer	Assess Isometric muscle strength.	4 weeks

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2022
• Primary Completion (Actual): November 6, 2022
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: March 6, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Diabetic neuropathy; Foot muscle energy technique; Isometric muscle strength; Motor nerve conduction velocity study
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: REC/2111/MTI.PT/2204061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No