Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients

January 5, 2021 updated by: Lama Saad El-Din Mahmoud

To investigate the effect of Neurodynamics Nerve flossing on femoral neuropathy in patients with haemophilia

Background: heamophilia is one of the serious chronic disorders in children and adolescents which results in less physical activities and restlessness hours than their peer.

HYPOTHESES:

This study will hypnotize that:

Neurodynamics Nerve flossing will have a significant effect on femoral neuropathy in patients with haemophilia

RESEARCH QUESTION:

will the Neurodynamics Nerve flossing has an effect on femoral neuropathy in patients with haemophilia?

Study Overview

Detailed Description

Haemophilic patients with Femoral Neuropathy will be randomly divided in two equal groups control group which will receive conventional selected exercise program and study group will receive the same exercise training program in addition to Neurodynamics Nerve flossing three times per week for three successive months.

The Evaluation will done pre and post interventions included:

femoral nerve motor conduction velocity, muscle test For Iliopsoas and Quadriceps muscles and Pain visual analogue scale.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • hemophilia A or B, all the patients
  • positive femoral nerve tension test
  • the Manual muscle test for iliopsoas and quadriceps muscles in all patients not less than grade 2 according to the oxford scale
  • the age ranging from (12:16) years
  • all the participants will be able to communicate verbally ,obey commands and instructions and co-operate with testing and training protocols

Exclusion Criteria:

  • any participants have auditory, visual and sever cardiac disorders
  • Patients who have mild degree of hemophilia
  • Patients who have joint, muscle bleeding or pain in the lower limb in the preceding 3 weeks
  • patients with any other neurological disorders or musculoskeletal disorders or deformities of the lower limb.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
received conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve

Neurodynamics Nerve flossing for femoral nerve that includes two techniques inform of:

"slider technique" and the second is the "tensioner technique

Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise
Experimental: control group
received conventional selected exercise program in form of: Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps in heamophilic patient The iliopsoas & quadriceps muscles strength exercise
Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electromyography Nerve conduction study
Time Frame: 12 weeks
Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device
12 weeks
Femoral Nerve Tension Test, for femoral nerve injury
Time Frame: 12 weeks

Femoral Nerve Tension Test is a neural tension test used to stress the femoral nerve

A positive test was be reproduction of the patient's symptoms as burning discomfort in the groin or anterior thigh occurred if there was femoral nerve involvement.

12 weeks
Manual muscle test, Oxford five grades of muscle power assessment
Time Frame: 12 weeks

The group Manual muscle test was used for testing the strength of iliopsoas and quadriceps muscles, according to the Oxford Scale as the Muscle strength is often rated on a scale of 0/5 as follow:

(0/5) no contraction of muscle, (1/5) muscle flicker contraction, but no movement (2/5) movement possible, but not against gravity (test the joint in its horizontal plane), (3/5) movement possible against gravity, but not against resistance by the therapist, (4/5) movement possible against some resistance by the examiner and (5/5) normal strength

12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Lama S Mahmoud, PHD, lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

October 30, 2020

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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