NCT05790421

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

March 6, 2023

Last Update Submit

June 13, 2023

Conditions

Keywords

Diabetic neuropathyFoot muscle energy techniqueIsometric muscle strengthMotor nerve conduction velocity study

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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

Other: Foot Muscle Energy TechniqueOther: 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

Other: Conventional Physical Therapy Program

Interventions

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.

Also known as: Foot MET
Group A

Graduated active resisted range of motion exercises for both UL and LL and graduated gait training

Group AGroup B

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Uncontrolled non-insulin dependent diabetes and diagnosed for \< 10 years, neural, muscular, and skeletal system deformities; radiculopathy; and psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 University

El-Sheikh Zayed City, Giza Governorate, 1133, Egypt

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Of Neurological Physical Therapy - Faculty Of Physical Therapy - October 6 University

Study Record Dates

First Submitted

March 6, 2023

First Posted

March 30, 2023

Study Start

April 2, 2022

Primary Completion

November 6, 2022

Study Completion

January 3, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations