xml: <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/NCT06008665</url>
    </required_header>
    <id_info>
      <org_study_id>01345</org_study_id>
      <nct_id>NCT06008665</nct_id>
    </id_info>
    <brief_title>Effects of Action Observation Therapy With Otago Exercises on Balance and Quality of Life in Older Adults</brief_title>
    <official_title>Effects of Action Observation Therapy With Otago Exercises on Balance and Quality of Life in Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Health Education Research Foundation (HERF)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Riphah International 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>
        This study is to determine to see the effect of action observation therapy with otago&#xD;
        exercise on Balance and Quality Of Life.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is designed to reduce the Fall and balance problems and increase the quality of&#xD;
        life in older adults. Balance, which declines with aging, is a complex sensory-motor process&#xD;
        in which the visual, vestibular, and musculoskeletal systems work cooperatively to produce&#xD;
        postural stability and loss of balance control causes falls, resulting in severe injuries,&#xD;
        such as fractures, causing longstanding pain, lower quality of life, disability, and even&#xD;
        death.&#xD;
  &#xD;
        Interventions include balance and postural control that can help older people to avoid&#xD;
        falling, through tai chi methods, gait training, strengthening exercises, and balance&#xD;
        training programs.&#xD;
  &#xD;
        The Otago Exercise Program comprises muscle strength exercises, balance training, and&#xD;
        walking. The Otago workout program is based on individual tolerance, consisting of&#xD;
        strengthening, balance, walking, and aerobic activities, and can be done at home environment&#xD;
        Action observation is a cognitive intervention training strategy that involves observing&#xD;
        other people's performance in order to promote motor learning.&#xD;
  &#xD;
        Participants were instructed to watch a video on a screen while comfortably seated in a chair&#xD;
        with armrests. They were not allowed to follow along or engage in any movement while watching&#xD;
        the video. After the watching video of each component of otago exercises the exercises&#xD;
        performed by participant based on the content of the video.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 12, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>One of my group is experimental and the other one is controlled</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Berg Balance Scale</measure>
      <time_frame>Baseline to 12th week</time_frame>
      <description>The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance. A five-point ordinal scale, ranging from 0-4. &quot;0&quot; indicates the lowest level of function and &quot;4&quot; the highest level of function. Total Score = 56. Score 0-20(High Risk of Fall), 21-40(Moderate Risk of Fall) and 41-54(Low Rosk of Fall)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Time Up and Go test</measure>
      <time_frame>Baseline to 12th week</time_frame>
      <description>The Timed Up and Go test is to identify mobility and balance impairments in older adults. Score ≥12 seconds (Risk of Fall)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Functional Reach Test</measure>
      <time_frame>Baseline to 12th week</time_frame>
      <description>The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults. Score &gt;6 inches (High Risk of Fall), 6-10 inches (Risk of Fall)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Short Form 36</measure>
      <time_frame>Baseline to 12th week</time_frame>
      <description>The SF 36 is use to measure the Quality of Life</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Balance; Distorted</condition>
    <arm_group>
      <arm_group_label>Action observation therapy with Otago exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants' Instructions:&#xD;
  Watch a video on a 22-inch screen.&#xD;
  Screen positioned 1 meter away from them.&#xD;
  Comfortably seated in a chair with armrests.&#xD;
  No following along or movement allowed.&#xD;
  Video Features: Model in the video is 70 years old or older. Model similar to the participants.&#xD;
  Video Viewing: Duration: 17 minutes (1 minute per video). Supervised by the same investigator. Quiet environment during observation.&#xD;
  Physical Training Session: Supervised by a therapist.&#xD;
  Duration: 35 minutes (2 minutes max per session).&#xD;
  Based on content from the video.&#xD;
  Action Observation Training: Activities during the physical education workshops featured in the videos.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Otago exercise</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Strength Training Component:Knee Flexor, Knee Extensor, Hip Adductors, Ankle Planter Flexors, Ankle Dorsi Flexors&#xD;
  Balance Training Component:&#xD;
  Activities include: Walking backwards, Walking in a figure of eight, Heel-toe walking, Standing on one leg, Walking on the heels, Walking on the toes, Heel-toe walking backwards, Standing up from a sitting position, Walking up stairs.&#xD;
  Training Frequency and Guidance: Exercises conducted three times a week,Guidance provided by a therapist.&#xD;
  Training Session Duration: Each session lasts for 35-40 minutes.&#xD;
  Warm-up and Cool-down:5-minute warm-up before each session and 5-minute cool-down after each session.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Action Observation Therapy and Otago Exercises</intervention_name>
      <description>Strength Training Component:Knee Flexor, Knee Extensor, Hip Adductors, Ankle Planter Flexors, Ankle Dorsi Flexors&#xD;
  Balance Training Component:&#xD;
  Activities include: Walking backwards, Walking in a figure of eight, Heel-toe walking, Standing on one leg, Walking on the heels, Walking on the toes, Heel-toe walking backwards, Standing up from a sitting position, Walking up stairs.&#xD;
  Training Frequency and Guidance: Exercises conducted three times a week,Guidance provided by a therapist.&#xD;
  Training Session Duration: Each session lasts for 35-40 minutes. Warm-up and Cool-down:5-minute warm-up before each session and 5-minute cool-down after each session.</description>
      <arm_group_label>Action observation therapy with Otago exercise</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Otago Exercises</intervention_name>
      <description>Strength Training Component:Knee Flexor, Knee Extensor, Hip Adductors, Ankle Planter Flexors, Ankle Dorsi Flexors&#xD;
  Balance Training Component:&#xD;
  Activities include: Walking backwards, Walking in a figure of eight, Heel-toe walking, Standing on one leg, Walking on the heels, Walking on the toes, Heel-toe walking backwards, Standing up from a sitting position, Walking up stairs.</description>
      <arm_group_label>Otago exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Both genders&#xD;
  &#xD;
            -  Participant experience fall &gt; one time in last 6 months.&#xD;
  &#xD;
            -  Participants having Berg Balance score between 20 to 40&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ●Abnormalities in visual, auditory, or vestibular system&#xD;
  &#xD;
            -  Limb defects&#xD;
  &#xD;
            -  History of recent fractures&#xD;
  &#xD;
            -  Participants with Cardiovascular, Cerebrovascular disease or traumatic brain injury&#xD;
               and Epilepsy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Waqar Ahmed Awan, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Waqar Ahmed Awan, PhD</last_name>
      <phone>+923335348846</phone>
      <email>waqar.ahmed@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Waqar Awan Awan</name>
        <address>
          <city>Islamabad</city>
          <zip>44000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Waqar Awan Awan, PhD</last_name>
        <phone>03335348846</phone>
        <email>waqar.ahmed@riphah.edu.pk</email>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06008665
  org study id: 01345
  nct id: NCT06008665
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is to determine to see the effect of action observation therapy with otago
        exercise on Balance and Quality Of Life.
  This study is designed to reduce the Fall and balance problems and increase the quality of
        life in older adults. Balance, which declines with aging, is a complex sensory-motor process
        in which the visual, vestibular, and musculoskeletal systems work cooperatively to produce
        postural stability and loss of balance control causes falls, resulting in severe injuries,
        such as fractures, causing longstanding pain, lower quality of life, disability, and even
        death.
  
        Interventions include balance and postural control that can help older people to avoid
        falling, through tai chi methods, gait training, strengthening exercises, and balance
        training programs.
  
        The Otago Exercise Program comprises muscle strength exercises, balance training, and
        walking. The Otago workout program is based on individual tolerance, consisting of
        strengthening, balance, walking, and aerobic activities, and can be done at home environment
        Action observation is a cognitive intervention training strategy that involves observing
        other people's performance in order to promote motor learning.
  
        Participants were instructed to watch a video on a screen while comfortably seated in a chair
        with armrests. They were not allowed to follow along or engage in any movement while watching
        the video. After the watching video of each component of otago exercises the exercises
        performed by participant based on the content of the video.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: One of my group is experimental and the other one is controlled
  measure: Berg Balance Scale
  time frame: Baseline to 12th week
  description: The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56. Score 0-20(High Risk of Fall), 21-40(Moderate Risk of Fall) and 41-54(Low Rosk of Fall)
  measure: Time Up and Go test
  time frame: Baseline to 12th week
  description: The Timed Up and Go test is to identify mobility and balance impairments in older adults. Score ≥12 seconds (Risk of Fall)
  measure: Functional Reach Test
  time frame: Baseline to 12th week
  description: The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults. Score >6 inches (High Risk of Fall), 6-10 inches (Risk of Fall)
  measure: Short Form 36
  time frame: Baseline to 12th week
  description: The SF 36 is use to measure the Quality of Life
  arm group label: Action observation therapy with Otago exercise
  arm group type: Experimental
  description: Participants' Instructions:
  Watch a video on a 22-inch screen.
  Screen positioned 1 meter away from them.
  Comfortably seated in a chair with armrests.
  No following along or movement allowed.
  Video Features: Model in the video is 70 years old or older. Model similar to the participants.
  Video Viewing: Duration: 17 minutes (1 minute per video). Supervised by the same investigator. Quiet environment during observation.
  Physical Training Session: Supervised by a therapist.
  Duration: 35 minutes (2 minutes max per session).
  Based on content from the video.
  Action Observation Training: Activities during the physical education workshops featured in the videos.
  arm group label: Otago exercise
  arm group type: Active Comparator
  description: Strength Training Component:Knee Flexor, Knee Extensor, Hip Adductors, Ankle Planter Flexors, Ankle Dorsi Flexors
  Balance Training Component:
  Activities include: Walking backwards, Walking in a figure of eight, Heel-toe walking, Standing on one leg, Walking on the heels, Walking on the toes, Heel-toe walking backwards, Standing up from a sitting position, Walking up stairs.
  Training Frequency and Guidance: Exercises conducted three times a week,Guidance provided by a therapist.
  Training Session Duration: Each session lasts for 35-40 minutes.
  Warm-up and Cool-down:5-minute warm-up before each session and 5-minute cool-down after each session.
  intervention type: Other
  intervention name: Action Observation Therapy and Otago Exercises
  description: Strength Training Component:Knee Flexor, Knee Extensor, Hip Adductors, Ankle Planter Flexors, Ankle Dorsi Flexors
  Balance Training Component:
  Activities include: Walking backwards, Walking in a figure of eight, Heel-toe walking, Standing on one leg, Walking on the heels, Walking on the toes, Heel-toe walking backwards, Standing up from a sitting position, Walking up stairs.
  Training Frequency and Guidance: Exercises conducted three times a week,Guidance provided by a therapist.
  Training Session Duration: Each session lasts for 35-40 minutes. Warm-up and Cool-down:5-minute warm-up before each session and 5-minute cool-down after each session.
  arm group label: Action observation therapy with Otago exercise
  intervention type: Other
  intervention name: Otago Exercises
  description: Strength Training Component:Knee Flexor, Knee Extensor, Hip Adductors, Ankle Planter Flexors, Ankle Dorsi Flexors
  Balance Training Component:
  Activities include: Walking backwards, Walking in a figure of eight, Heel-toe walking, Standing on one leg, Walking on the heels, Walking on the toes, Heel-toe walking backwards, Standing up from a sitting position, Walking up stairs.
  arm group label: Otago exercise
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Waqar Ahmed Awan, PhD
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Waqar Ahmed Awan, PhD
  phone: +923335348846
  email: waqar.ahmed@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  country: Pakistan
  responsible party type: Sponsor
  sharing ipd: No