NCT05628168

Brief Summary

Neurodynamic mobilization Techniques and Selected Physical program used as a treatment for diabetic neuropathy patients and assessed by nerve condition study and function outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

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

December 5, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

November 13, 2022

Last Update Submit

November 16, 2022

Conditions

Keywords

Neurodynamic technique; Sensory nerve conduction study; Motor nerve conduction study; Functional outcome; Diabetic polyneuropathy.

Outcome Measures

Primary Outcomes (1)

  • Effect of Neurodynamic Mobilization Techniques in Patients With Diabetic Neuropathy

    This study aimed to investigate neurodynamic mobilization effect on sensory and motor nerve conduction study, pain, and functional activity in patients with type 2 diabetic neuropathy and will be assessed through Katz index and NIHON KODEN EMG device.

    5-6 months

Study Arms (2)

Group A

EXPERIMENTAL

The NMG received three sessions/week for 4 weeks with each session lasting for 30 min including slider and tension neurodynamic techniques.

Other: Neurodynamic Mobilization TechniquesOther: Selected Physical Therapy Program

Group B

ACTIVE COMPARATOR

The participants only received a selected therapy program similar to the NMG with no change in duration.

Other: Selected Physical Therapy Program

Interventions

The slider neurodynamic technique for the median nerve is conducted.Tensioner neurodynamic technique for the tibial nerve is conducted.

Group A

The participants only received a selected therapy program similar to the NMG with no change in duration.

Group AGroup B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with T2DM for ≥10 years determined by electrophysiological measurements were enrolled.
  • The participants regularly took their diabetes medications during the assessment and treatment period.

You may not qualify if:

  • Uncontrolled T2DM and diagnosed with T2DM for \< 10 years.
  • Patients with 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
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy at department of Neurology

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 28, 2022

Study Start

December 5, 2021

Primary Completion

May 10, 2022

Study Completion

June 2, 2022

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations