Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy

Sponsor

October 6 University (Other)

Overall Status

Completed

CT.gov ID

NCT05790421

Collaborator

(none)

Enrollment

Location

Arms

9.1

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Foot Muscle Energy Technique in Diabetic Neuropathy Patients	Other: Foot Muscle Energy Technique Other: Conventional Physical Therapy Program	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy: A Randomized Controlled Trial

Actual Study Start Date :

Apr 2, 2022

Actual Primary Completion Date :

Nov 6, 2022

Actual Study Completion Date :

Jan 3, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Motor nerve conduction study [4 weeks]
Assess both tibial and deep peroneal motor nerve conduction velocity.
Toe Strength Dynamometer [4 weeks]
Assess Isometric muscle strength.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	October 6 University	El-Sheikh Zayed City	Giza	Egypt	1133

Sponsors and Collaborators

October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Magdy Alshimy, Lecturer Of Neurological Physical Therapy - Faculty Of Physical Therapy - October 6 University, October 6 University

ClinicalTrials.gov Identifier:

NCT05790421

Other Study ID Numbers:

REC/2111/MTI.PT/2204061

First Posted:

Mar 30, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmed Magdy Alshimy, Lecturer Of Neurological Physical Therapy - Faculty Of Physical Therapy - October 6 University, October 6 University

Diabetic neuropathy; Foot muscle energy technique; Isometric muscle strength; Motor nerve conduction velocity study

Additional relevant MeSH terms:

Peripheral Nervous System Diseases

Diabetic Neuropathies

Study Results

No Results Posted as of Mar 30, 2023