Effect of Foot Muscle Energy Technique in Patients With Diabetic Neuropathy
1 other identifier
interventional
44
1 country
1
Brief Summary
Foot muscle energy technique and conventional physical therapy program administered in patients with type 2 Diabetic Neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
1 active site
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2023
CompletedFirst Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedJune 15, 2023
June 1, 2023
7 months
March 6, 2023
June 13, 2023
Conditions
Keywords
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
EXPERIMENTALParticipants received foot muscle energy techniques and conventional physical therapy program for three sessions/week for 4 weeks, each lasting 30 min
Group B
EXPERIMENTALParticipants received conventional physical therapy program only for three sessions/week for 4 weeks, each lasting 30 min
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.
Graduated active resisted range of motion exercises for both UL and LL and graduated gait training
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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