<?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>IRCT20260715070212N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-20</date_registration>
      <primary_sponsor>Islam College of Physical Therapy</primary_sponsor>
      <public_title>Effects of Multimodal Balance Training with and without Auditory Cues on Balance, Gait Mobility, Risk of Fall and Quality of Life in Patients with Chronic Stroke</public_title>
      <acronym></acronym>
      <scientific_title>Effects of Multimodal Balance Training with and without Auditory Cues on Balance, Gait Mobility, Risk of Fall and Quality of Life in Patients with Chronic Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>42</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91696</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: None, Randomization description: Participants were gathered using non-probability convenient sampling and randomly assigned into two equal groups of 21 using a simple randomization method (lottery system). The unit of randomization was the individual patient, and allocation concealment was maintained using sealed envelopes until group assignments were determined, Blinding description: This study utilized a single-blind approach. The outcome assessors who recorded the data at baseline, 6 weeks, and 12 weeks were kept completely blinded to the treatment group assignments of the participants. The physical therapists delivering the interventions and the participants themselves were not blinded due to the nature of physical exercise protocols.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Stroke.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: ​Multimodal balance training with auditory cues. Includes trunk stability, weight shifts, visual cue walking, ball-based diagonal reaching, and rhythmic auditory stimulation (RAS) delivered via a digital metronome. Sessions lasted 45 minutes, administered 2 times a week for 12 weeks (24 sessions total). Intervention 2: Control group: Multimodal balance training without auditory cues. Includes identical trunk stability, weight shifts, visual cue walking, and ball-based diagonal reaching exercises without rhythmic audio feedback. Sessions lasted 45 minutes, administered 2 times a week for 12 weeks (24 sessions total).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
De-identified individual participant data (IPD) including demographic variables, baseline characteristics, and pre/post intervention clinical scale scores (BBS, TUG, FES-I, SSQOL) along with the study protocol and data dictionary.

When:
Data will become available immediately following publication of the study results and will remain accessible indefinitely.

To whom:
Available to researchers, clinicians, and academic students working in the fields of physical therapy, neurological rehabilitation, and clinical biomechanics.

Conditions:
For the purpose of systematic reviews, meta-analyses, secondary independent data analysis, or replication studies.

Where to obtain:
The dataset will be publicly accessible via the open-access science repository medRxiv.

How to obtain:
No formal request process is required as the data will be directly downloadable as open-access files from the repository repository URL.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hammad Sattar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasrur Road, Sialkot</address>
        <city>Sialkot</city>
        <country1>Pakistan</country1>
        <zip>51310</zip>
        <telephone>+92 321 1665247</telephone>
        <email>hbari023@gmail.com</email>
        <affiliation>Islam College of Physical Therapy</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hammad Sattar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasrur Road, Sialkot</address>
        <city>Sialkot</city>
        <country1>Pakistan</country1>
        <zip>51310</zip>
        <telephone>+92 321 1665247</telephone>
        <email>hbari023@gmail.com</email>
        <affiliation>Islam College of Physical Therapy</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosed with a unilateral chronic stroke (&gt;1 year post-stroke), aged between 45 to 70 years</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Aphasia
Moderate to severe cognitive impairment (MMSE &lt; 24)
Severe cardiac diseases
Uncontrolled hypertension
Non-healing ulcers
Osteoporosis
Severe visuospatial deficits</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G46.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cerebellar stroke syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: ​Multimodal balance training with auditory cues. Includes trunk stability, weight shifts, visual cue walking, ball-based diagonal reaching, and rhythmic auditory stimulation (RAS) delivered via a digital metronome. Sessions lasted 45 minutes, administered 2 times a week for 12 weeks (24 sessions total).</i_keyword>
      <i_keyword>Control group: Multimodal balance training without auditory cues. Includes identical trunk stability, weight shifts, visual cue walking, and ball-based diagonal reaching exercises without rhythmic audio feedback. Sessions lasted 45 minutes, administered 2 times a week for 12 weeks (24 sessions total).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gait, balance performance, and functional mobility. Timepoint: Measured at baseline (0 weeks), at mid-intervention (6 weeks), and post-intervention (12 weeks). Method of measurement: Berg Balance Scale (BBS).</prim_outcome>
      <prim_outcome>Dynamic balance and functional mobility status. Timepoint: Measured at baseline (0 weeks), at mid-intervention (6 weeks), and post-intervention (12 weeks). Method of measurement: Timed Up and Go (TUG) test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Fear of falling and balance confidence during daily activities. Timepoint: Measured at baseline (0 weeks), at mid-intervention (6 weeks), and post-intervention (12 weeks). Method of measurement: Fall Efficacy Scale-International (FES-I).</sec_outcome>
      <sec_outcome>Health-related quality of life across specific stroke domains. Timepoint: Measured at baseline (0 weeks), at mid-intervention (6 weeks), and post-intervention (12 weeks). Method of measurement: Stroke Specific Quality of Life Scale (SSQOL).</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>Islam College of Physical Therapy</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-08-15</approval_date>
        <contact_name>Research Ethical Committee, Islam Teaching Hospital</contact_name>
        <contact_address>Pasrur Road, Islam teaching hospital, Sialkot Sialkot Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
