<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04448275</url>
  </required_header>
  <id_info>
    <org_study_id>P.T./REC /012/002733</org_study_id>
    <nct_id>NCT04448275</nct_id>
  </id_info>
  <brief_title>Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients</brief_title>
  <official_title>Effect of Neurodynamics Nerve Flossing on Femoral Neuropathy in Haemophilic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lama Saad El-Din Mahmoud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>October 6 University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effect of Neurodynamics Nerve flossing on femoral neuropathy in patients&#xD;
      with haemophilia&#xD;
&#xD;
      Background: heamophilia is one of the serious chronic disorders in children and adolescents&#xD;
      which results in less physical activities and restlessness hours than their peer.&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
      This study will hypnotize that:&#xD;
&#xD;
      Neurodynamics Nerve flossing will have a significant effect on femoral neuropathy in patients&#xD;
      with haemophilia&#xD;
&#xD;
      RESEARCH QUESTION:&#xD;
&#xD;
      will the Neurodynamics Nerve flossing has an effect on femoral neuropathy in patients with&#xD;
      haemophilia?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Haemophilic patients with Femoral Neuropathy will be randomly divided in two equal groups&#xD;
      control group which will receive conventional selected exercise program and study group will&#xD;
      receive the same exercise training program in addition to Neurodynamics Nerve flossing three&#xD;
      times per week for three successive months.&#xD;
&#xD;
      The Evaluation will done pre and post interventions included:&#xD;
&#xD;
      femoral nerve motor conduction velocity, muscle test For Iliopsoas and Quadriceps muscles and&#xD;
      Pain visual analogue scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>control group which received conventional selected exercise program in form of Ultrasound therapy The flexibility exercises for iliopsoas &amp; quadriceps The iliopsoas &amp; quadriceps muscles strength exercise&#xD;
and study group received the same exercise training program in addition to Neurodynamics Nerve flossing three times per week for three successive months</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Electromyography Nerve conduction study</measure>
    <time_frame>12 weeks</time_frame>
    <description>Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Femoral Nerve Tension Test, for femoral nerve injury</measure>
    <time_frame>12 weeks</time_frame>
    <description>Femoral Nerve Tension Test is a neural tension test used to stress the femoral nerve&#xD;
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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Manual muscle test, Oxford five grades of muscle power assessment</measure>
    <time_frame>12 weeks</time_frame>
    <description>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:&#xD;
(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</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Femoral Neuropathy in Haemophilic Patients</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>received conventional selected exercise program in form of: Ultrasound therapy The flexibility exercises for iliopsoas &amp; quadriceps in heamophilic patient The iliopsoas &amp; quadriceps muscles strength exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neurodynamics Nerve flossing</intervention_name>
    <description>Neurodynamics Nerve flossing for femoral nerve that includes two techniques inform of:&#xD;
&quot;slider technique&quot; and the second is the &quot;tensioner technique</description>
    <arm_group_label>study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional selected exercise program</intervention_name>
    <description>Ultrasound therapy The flexibility exercises for iliopsoas &amp; quadriceps The iliopsoas &amp; quadriceps muscles strength exercise</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hemophilia A or B, all the patients&#xD;
&#xD;
          -  positive femoral nerve tension test&#xD;
&#xD;
          -  the Manual muscle test for iliopsoas and quadriceps muscles in all patients not less&#xD;
             than grade 2 according to the oxford scale&#xD;
&#xD;
          -  the age ranging from (12:16) years&#xD;
&#xD;
          -  all the participants will be able to communicate verbally ,obey commands and&#xD;
             instructions and co-operate with testing and training protocols&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any participants have auditory, visual and sever cardiac disorders&#xD;
&#xD;
          -  Patients who have mild degree of hemophilia&#xD;
&#xD;
          -  Patients who have joint, muscle bleeding or pain in the lower limb in the preceding 3&#xD;
             weeks&#xD;
&#xD;
          -  patients with any other neurological disorders or musculoskeletal disorders or&#xD;
             deformities of the lower limb.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lama S Mahmoud, PHD</last_name>
    <role>Study Director</role>
    <affiliation>lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>October 6 University</name>
      <address>
        <city>Giza</city>
        <state>El-Sheikh Zayed City Giza 1133 Egypt</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>January 5, 2021</last_update_submitted>
  <last_update_submitted_qc>January 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>October 6 University</investigator_affiliation>
    <investigator_full_name>Lama Saad El-Din Mahmoud</investigator_full_name>
    <investigator_title>Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity</investigator_title>
  </responsible_party>
  <keyword>Neurodynamics,</keyword>
  <keyword>Nerve flossing;</keyword>
  <keyword>femoral neuropathy</keyword>
  <keyword>, haemophilia,</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Nervous System Diseases</mesh_term>
    <mesh_term>Femoral Neuropathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04448275
org study id: P.T./REC /012/002733
nct id: NCT04448275
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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?
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: control group which received conventional selected exercise program in form of Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise
and study group received the same exercise training program in addition to Neurodynamics Nerve flossing three times per week for three successive months
primary purpose: Treatment
masking: None (Open Label)
measure: Electromyography Nerve conduction study
time frame: 12 weeks
description: Femoral Nerve motor conduction velocity (m/sec.) , via the Neuropack S1 MEB9004 EMG device
measure: Femoral Nerve Tension Test, for femoral nerve injury
time frame: 12 weeks
description: 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.
measure: Manual muscle test, Oxford five grades of muscle power assessment
time frame: 12 weeks
description: 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
arm group label: study group
arm group type: Experimental
description: received conventional selected exercise program and in addition to Neurodynamics Nerve flossing for femoral nerve
arm group label: control group
arm group type: Experimental
description: 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
intervention type: Other
intervention name: Neurodynamics Nerve flossing
description: Neurodynamics Nerve flossing for femoral nerve that includes two techniques inform of:
"slider technique" and the second is the "tensioner technique
arm group label: study group
intervention type: Other
intervention name: conventional selected exercise program
description: Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise
arm group label: control group
arm group label: study group
criteria: 
gender: Male
minimum age: 12 Years
maximum age: 16 Years
healthy volunteers: No
last name: Lama S Mahmoud, PHD
role: Study Director
affiliation: lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: October 6 University
investigator full name: Lama Saad El-Din Mahmoud
investigator title: Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity
mesh term: Peripheral Nervous System Diseases
mesh term: Femoral Neuropathy
sharing ipd: No