<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20250801066719N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-08-19</date_registration>
      <primary_sponsor>The University of Shahid Beheshti</primary_sponsor>
      <public_title>comparison the effect of DNS exercise with and without the use of VR on Hyperlordosis with nonspecific chronic low back pain</public_title>
      <acronym>Dynamic neuromuscular exercise(DNS)</acronym>
      <scientific_title>Comparison of the Effect of six Weeks of Dynamic Neuromuscular Stabilization (DNS) Exercise with and without the Use of Virtual Reality (VR) on pain, Balance, Proprioception, Range of Motion and Lumbar Arch Degree in Middle-aged Women with Hyperlordosis with nonspecific chronic low back pain: A randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-08-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85314</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sequence Generation
To keep an equal 1 : 1 : 1 allocation across the three study arms—
Group A = DNS exercise only
Group B = DNS + virtual-reality (VR) exercise
Group C = no-treatment control
I first divide the total sample size n into three equal parts (n / 3 per group).
Then I prepare n / 3 identical paper slips marked “A”, n / 3 slips marked “B”, and n / 3 slips marked “C.”
All slips are folded twice so the label cannot be seen, placed together in a single opaque, non-transparent container, and thoroughly mixed before recruitment begins.
For each eligible participant I (or an independent staff member) draw one slip blindly from the container.
The letter on the slip immediately determines that participant’s assignment.
After a slip is drawn it is removed from the pool and stored separately, so the remaining probabilities stay constant (sampling without replacement).</study_design>
      <phase>N/A</phase>
      <hc_freetext>هايپرلوردوزيس همراه با كمردرد مزمن غيراختصاصي.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The group receiving dynamic neuromuscular training combined with virtual reality technology. Participants receive Dynamic Neuromuscular Stabilization exercises combined with virtual reality. The program lasts 6 weeks (18 sessions) with 3 sessions per week, and each session is 50 minutes. Training is conducted at the Fitness and Sports Rehabilitation Club, Faculty of Sport Sciences, Shahid Beheshti University. The VR device is the Meta Quest 3 headset and the selected game is Dodgeball, which is used to encourage controlled lumbar flexion. Each session includes 5 minutes of warm-up (light stretching, walking, simple mobility), 20 minutes of DNS, 20 minutes of VR-based training (Dodgeball tasks for balance, weight-shift, reaching, and trunk control), and 5 minutes of cool-down (gentle stretching and walking). DNS content covers diaphragmatic breathing and intra-abdominal pressure (IAP) work performed in developmental positions derived from infant motor patterns, including baby-rock/rolling, prone, side-lying, quadruped, bear position, tripod stance, and modified squat. The auxiliary equipment used during DNS consists of elastic resistance bands, light dumbbells, and a Pilates ball; the chosen VR game (Dodgeball) is selected based on prior literature for this population. Intervention 2: Intervention group 2:The group receiving dynamic neuromuscular training without the use of virtual reality technology. The program lasts 6 weeks (18 sessions) with 3 sessions per week. Each session is 50 minutes. Training is conducted at the Fitness and Sports Rehabilitation Club in the Faculty of Sport Sciences, Shahid Beheshti University. DNS exercises are performed for 40 minutes, with 5 minutes of warm-up at the beginning and 5 minutes of cool-down at the end, consisting of light stretching, walking, and simple mobility drills. The DNS component includes core patterns of diaphragmatic breathing and intra-abdominal pressure (IAP) in developmental positions derived from infant motor patterns, such as baby rock, prone, side-lying, quadruped, bear position, tripod stance, and modified squat. Auxiliary equipment during DNS includes elastic resistance bands, light dumbbells, and a Pilates ball. Intervention 3: Control group: The control group receiving no intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is At this stage, a final decision regarding the sharing of Individual Participant Data (IPD) has not been made due to the need for coordination with the research team, ethical considerations, and institutional data sharing policies. A decision will be made after careful review of legal and scientific aspects.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niusha Tashakori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafi'pour Sports Complex, Opposite Niloufar Alley, North Vafa-Azar Street, East Ferdows Boulevard, Ayatollah Kashani Street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1481855943</zip>
        <telephone>+98 21 4409 5051</telephone>
        <email>Nta.1379.nt@gmail.com</email>
        <affiliation>The University of Shahid Beheshti</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niusha Tashakori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shafi'pour Sports Complex, Opposite Niloufar Alley, North Vafa-Azar Street, East Ferdows Boulevard, Ayatollah Kashani Street, Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1481855943</zip>
        <telephone>+98 21 4409 5051</telephone>
        <email>nta.1379.nt@gmail.com</email>
        <affiliation>The University of Shahid Beheshti</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women between 30-50 years of age
Lumbar lordosis greater than 40 degrees
Body-mass index (BMI) between 18.5 and 27
Pain intensity between 3 and 7 on the Visual Analogue Scale (VAS)</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>history of spinal fractures, surgery, or joint disease
Use of orthotic insoles, a cane, antidepressant or narcotic medications, or muscle relaxants within 30 days prior to the study, and no significant visual impairment or motor disorders that would prevent the use of virtual-reality equipment
Presence of pathological signs related to the condition, such as heart disease, cancer, tumors, previous surgery, etc.
Presence of orthopedic deformities or neurosurgical diseases
Presence of disc degeneration or other conditions that could influence the interpretation of the results (e.g., severe fibromyalgia or rheumatoid arthritis in combination with other treatments)
Surgery or pregnancy within the past 30 days
Use of devices or apparatuses for treating hyper-lordosis
Presence of any other postural abnormalities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M54.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Low back pain</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The group receiving dynamic neuromuscular training combined with virtual reality technology. Participants receive Dynamic Neuromuscular Stabilization exercises combined with virtual reality. The program lasts 6 weeks (18 sessions) with 3 sessions per week, and each session is 50 minutes. Training is conducted at the Fitness and Sports Rehabilitation Club, Faculty of Sport Sciences, Shahid Beheshti University. The VR device is the Meta Quest 3 headset and the selected game is Dodgeball, which is used to encourage controlled lumbar flexion. Each session includes 5 minutes of warm-up (light stretching, walking, simple mobility), 20 minutes of DNS, 20 minutes of VR-based training (Dodgeball tasks for balance, weight-shift, reaching, and trunk control), and 5 minutes of cool-down (gentle stretching and walking). DNS content covers diaphragmatic breathing and intra-abdominal pressure (IAP) work performed in developmental positions derived from infant motor patterns, including baby-rock/rolling, prone, side-lying, quadruped, bear position, tripod stance, and modified squat. The auxiliary equipment used during DNS consists of elastic resistance bands, light dumbbells, and a Pilates ball; the chosen VR game (Dodgeball) is selected based on prior literature for this population.</i_keyword>
      <i_keyword>Intervention group 2:The group receiving dynamic neuromuscular training without the use of virtual reality technology. The program lasts 6 weeks (18 sessions) with 3 sessions per week. Each session is 50 minutes. Training is conducted at the Fitness and Sports Rehabilitation Club in the Faculty of Sport Sciences, Shahid Beheshti University. DNS exercises are performed for 40 minutes, with 5 minutes of warm-up at the beginning and 5 minutes of cool-down at the end, consisting of light stretching, walking, and simple mobility drills. The DNS component includes core patterns of diaphragmatic breathing and intra-abdominal pressure (IAP) in developmental positions derived from infant motor patterns, such as baby rock, prone, side-lying, quadruped, bear position, tripod stance, and modified squat. Auxiliary equipment during DNS includes elastic resistance bands, light dumbbells, and a Pilates ball.</i_keyword>
      <i_keyword>Control group: The control group receiving no intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hyperlordosis. Timepoint: Outcome assessments will be conducted at baseline and after the completion of the 6-week intervention period. Method of measurement: Hyperlordosis will be assessed using the Spinal Mouse device.</prim_outcome>
      <prim_outcome>Pain intensity. Timepoint: Outcome assessment will be conducted at baseline and after the completion of the 6-week intervention period. Method of measurement: Pain intensity will be measured using the Visual Analogue.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Static balance. Timepoint: Outcome assessment will be conducted at baseline and after the completion of the 6-week intervention period. Method of measurement: static Balance will be assessed using the Biodex Balance System.</sec_outcome>
      <sec_outcome>Dynamic balance. Timepoint: Outcome assessment will be conducted at baseline and after the completion of the 6-week intervention period. Method of measurement: Dynamic Balance will be assessed using the Biodex Balance System.</sec_outcome>
      <sec_outcome>Lumbar proprioception. Timepoint: Outcome assessment will be conducted at baseline and after the completion of the 6-week intervention period. Method of measurement: Lumbar Proprioception will be measured using a goniometer.</sec_outcome>
      <sec_outcome>Range of motion. Timepoint: Outcome assessment will be conducted at baseline and after the completion of the 6-week intervention period. Method of measurement: Range of motion will be measured using the MobeeMed device.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>shahid Beheshti University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-24</approval_date>
        <contact_name>Ethics committee of Shaid Beheshti University</contact_name>
        <contact_address>Shahid Shahriari Square, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
