<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/NCT04459832</url>
  </required_header>
  <id_info>
    <org_study_id>A Randomized Controlled Trial</org_study_id>
    <nct_id>NCT04459832</nct_id>
  </id_info>
  <brief_title>Optimal Duration of Stretching of the Hamstring Muscle Group in Elderly: A Randomized Controlled Trial</brief_title>
  <official_title>Optimal Time of Hamstring Stretch in Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</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>
      identification of optimal duration for hamstring muscle stretch by using 3 different time of&#xD;
      stretch 15,30,60 seconds .100 subjects will be participated in this study divided into 4&#xD;
      group one control and 3 experimental groups according to stretch time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abstract:&#xD;
&#xD;
      OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.&#xD;
&#xD;
      DESIGN: Randomized controlled trial Participants: In this trial, 100 participants will&#xD;
      participate in the study diagnosed with tight hamstring muscles (defined as the inability to&#xD;
      extend the knee to less than 20° of knee flexion) were randomly assigned to the control group&#xD;
      or one of the 3 intervention groups Interventions: The three experimental groups will&#xD;
      stretched 5 times per week for 4 weeks for 15, 30, and 60 seconds, respectively the control&#xD;
      group did not stretch Main Outcome Measures: The neurophysiological outcome measures included&#xD;
      peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary&#xD;
      outcome measures included knee ROM. All outcome measures will be assessed immediately after&#xD;
      the treatment session and 24 hours after the treatment session.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">August 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>randomized controlled trial study 100 participants will be recruited to participate in the study after assigning a conset form, participants will be divided into 4 group ,one control which will not receive stretch of hamstring and 3 experimental groups will recive different duration for hamstring stretch 15,30,60 and DSSEP will be measured as the primary outcome and knee ROM will be measured as a secondary outcomes in order to identify the optimal duration of hamstring stretch</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>The assessor, who took the measurements for both the intervention and control groups, was blinded to the subject's group, while the treating therapist was not blinded to the treatment intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Neurophysiological findings.</measure>
    <time_frame>Assessments of the change of DSSEPs from baseline to immediatly after session and at 24 hour after session</time_frame>
    <description>Neurophysiological findings included peak to peak somatosensory evoked potentials (DSSEPs) for L3,L4,L5,S1 dermatomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ROM</measure>
    <time_frame>Assessments of the change of Knee ROM from baseline to immediatly after session and at 24 hour after session</time_frame>
    <description>Each subject was then measured for knee extension ROM on both lower extremities</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Stretch</condition>
  <arm_group>
    <arm_group_label>15 second stretch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stretching of the hamstring muscles was performed by the primary researcher for 15 seconds. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible</description>
  </arm_group>
  <arm_group>
    <arm_group_label>30 second stretch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stretching of the hamstring muscles was performed by the primary researcher for 30 seconds. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible</description>
  </arm_group>
  <arm_group>
    <arm_group_label>60 second stretch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stretching of the hamstring muscles was performed by the primary researcher for 60 seconds. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The control group followed the same procedures except that no stretching force was applied at the end</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>stretch hamstring</intervention_name>
    <description>Stretching of the hamstring muscles was performed by the primary researcher. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible</description>
    <arm_group_label>15 second stretch</arm_group_label>
    <arm_group_label>30 second stretch</arm_group_label>
    <arm_group_label>60 second stretch</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects had to demonstrate &quot;tight&quot; hamstring muscles, defined as inability to extend&#xD;
             the knee to less than 20 degrees of knee flexion with the femur held at 90 degrees of&#xD;
             hip flexion while the person was positioned supine. Subjects were also screened to&#xD;
             rule out knee joint flexion contractures by checking knee extension ROM, while they&#xD;
             were lying in a prone position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Using of medical aids, and suffering from any neurological or cognitive impairment,&#xD;
             limiting cardio-respiratory conditions, or had undergone recent surgery (within the&#xD;
             past 12 months). Having any hip or knee replacements or any history of pathology in&#xD;
             the low back, hips, or knees for the 3 months prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Shimaa Taha Abu El Kasem</investigator_full_name>
    <investigator_title>Lecturer of Physical therapy</investigator_title>
  </responsible_party>
  <keyword>Stretching</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Hamstring</keyword>
  <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/NCT04459832
org study id: A Randomized Controlled Trial
nct id: NCT04459832
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
identification of optimal duration for hamstring muscle stretch by using 3 different time of
      stretch 15,30,60 seconds .100 subjects will be participated in this study divided into 4
      group one control and 3 experimental groups according to stretch time.
Abstract:

      OBJECTIVE: To explore the effect of variable stretching intervals on neural function and ROM.

      DESIGN: Randomized controlled trial Participants: In this trial, 100 participants will
      participate in the study diagnosed with tight hamstring muscles (defined as the inability to
      extend the knee to less than 20° of knee flexion) were randomly assigned to the control group
      or one of the 3 intervention groups Interventions: The three experimental groups will
      stretched 5 times per week for 4 weeks for 15, 30, and 60 seconds, respectively the control
      group did not stretch Main Outcome Measures: The neurophysiological outcome measures included
      peak to peak somatosensory evoked potential for dermatomes L3,L4,L5, and S1. Secondary
      outcome measures included knee ROM. All outcome measures will be assessed immediately after
      the treatment session and 24 hours after the treatment session.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomized controlled trial study 100 participants will be recruited to participate in the study after assigning a conset form, participants will be divided into 4 group ,one control which will not receive stretch of hamstring and 3 experimental groups will recive different duration for hamstring stretch 15,30,60 and DSSEP will be measured as the primary outcome and knee ROM will be measured as a secondary outcomes in order to identify the optimal duration of hamstring stretch
primary purpose: Treatment
masking: Single (Participant)
masking description: The assessor, who took the measurements for both the intervention and control groups, was blinded to the subject's group, while the treating therapist was not blinded to the treatment intervention.
measure: Neurophysiological findings.
time frame: Assessments of the change of DSSEPs from baseline to immediatly after session and at 24 hour after session
description: Neurophysiological findings included peak to peak somatosensory evoked potentials (DSSEPs) for L3,L4,L5,S1 dermatomes.
measure: ROM
time frame: Assessments of the change of Knee ROM from baseline to immediatly after session and at 24 hour after session
description: Each subject was then measured for knee extension ROM on both lower extremities
arm group label: 15 second stretch
arm group type: Experimental
description: Stretching of the hamstring muscles was performed by the primary researcher for 15 seconds. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible
arm group label: 30 second stretch
arm group type: Experimental
description: Stretching of the hamstring muscles was performed by the primary researcher for 30 seconds. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible
arm group label: 60 second stretch
arm group type: Experimental
description: Stretching of the hamstring muscles was performed by the primary researcher for 60 seconds. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible
arm group label: control
arm group type: Sham Comparator
description: The control group followed the same procedures except that no stretching force was applied at the end
intervention type: Procedure
intervention name: stretch hamstring
description: Stretching of the hamstring muscles was performed by the primary researcher. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible
arm group label: 15 second stretch
arm group label: 30 second stretch
arm group label: 60 second stretch
arm group label: control
criteria: 
gender: All
minimum age: 55 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Shimaa Taha Abu El Kasem
investigator title: Lecturer of Physical therapy
sharing ipd: No