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/NCT06041100</url>
    </required_header>
    <id_info>
      <org_study_id>AAU2-LBK1083</org_study_id>
      <nct_id>NCT06041100</nct_id>
    </id_info>
    <brief_title>What Are the Effects of a Bilateral Hip Exoskeleton During Daily Use by 65+ Adults?</brief_title>
    <official_title>Assessing the Long-term Effects of Wearing a Lower-limb Exoskeleton on Physical Activity and Quality of Life in Pre-frail Adults - a Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aalborg University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Imasen Electrical Industrial Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Aalborg Municipality</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Aalborg 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>
        Despite the huge popularity exoskeletons have gained in the past years and the benefits that&#xD;
        they have shown to provide to users, there are still many aspects of wearing an exoskeleton&#xD;
        that have yet to be determined. Therefore, the main objective of this study is to evaluate&#xD;
        the feasibility using the acceptability of incorporating a passive assistive bilateral&#xD;
        exoskeleton into the daily routine of pre-frail adults for a duration of 12-weeks. The second&#xD;
        aim of the study is to determine whether this effect can be sustained even after a period of&#xD;
        6-weeks following the cessation of usage.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Despite the high benefits of performing physical activity in terms of physical and cognitive&#xD;
        function, between 27-38% of Danish older adults do not meet the required physical activity&#xD;
        recommendations. Due to the longer life expectancy, the increasingly older population will&#xD;
        face gait disorders. These gait disorders will affect their motor and cognitive functions,&#xD;
        and impair the performance of daily physical activity and overall quality of life. Frailty is&#xD;
        one of the most frequent aging-related deficits observed in older adults, often characterized&#xD;
        by three of the following criteria: unintentional weight loss &gt;4.5 kg within the last year,&#xD;
        exhaustion, loss or slower mobility, loss of grip strength, and low physical activity.&#xD;
        However, pre-frail adults may present some of the aforementioned criteria and a score of ≤5&#xD;
        on the Tilburg Frailty Indicator. Therefore, there is an increasing need to provide the aging&#xD;
        population with devices capable of promoting physical activity and independent living.&#xD;
        Exoskeletons have been shown to facilitate physical activity in the older adult population by&#xD;
        improving metabolic costs, increasing walking speed, and preventing falls. However, whether&#xD;
        these benefits are only temporary, or can be maintained over a longer period, remains to be&#xD;
        determined. Therefore, it is of pivotal importance to assess the long-term effects of&#xD;
        exoskeletons, in terms of mobility, within the older adult population.&#xD;
  &#xD;
        The use of external mechanical walking devices started in the late 1890s. However, only in&#xD;
        the past two decades have gait-assisting exoskeletons, with increased human performance&#xD;
        capability, gained popularity. Exoskeletons have been shown to reduce metabolic cost, and&#xD;
        fatigue onset and increase walking velocity. Currently on the market, there are several&#xD;
        lower-limb exoskeletons that target older populations and people with gait and neurological&#xD;
        disabilities which are designed to enhance walking performance and reduce the muscle&#xD;
        activation required during walking activities. Wearing gait-assisting exoskeletons can&#xD;
        provide instant ease, delay fatigue onset, increase social engagement, and support&#xD;
        rehabilitation to recover normal walking capabilities. The effects of hip exoskeletons have&#xD;
        been previously investigated in terms of quality of life and improvement of gait performance.&#xD;
        However, the effect of long-term use has yet to be assessed. Hence, this study aims to&#xD;
        evaluate the impact of extended usage of a non-invasive passive hip exoskeleton on the&#xD;
        quality of life of older adults. This will be achieved by analyzing the spatiotemporal gait&#xD;
        characteristics in a feasibility study conducted over a 12-week period of consistent device&#xD;
        usage. Additionally, the study aims to ascertain the persistence of these effects for a&#xD;
        duration of 6 weeks post-usage.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 6, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 20, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>All participants will complete three test sessions:&#xD;
  An initial assessment (baseline)&#xD;
  A 4-week assessment and&#xD;
  A 12-week assessment.&#xD;
  Around 8-10 participants will be invited for a follow-up assessment 6-weeks post after the trial has ended.&#xD;
  All participants will be instructed to wear the device 30 minutes daily during moderate to intensive physical activities. They will be required to provide a weekly overview of their usage and experience with the device.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Walking speed</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>Changes in speed (m/s) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Step length</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>Changes in step length (cm) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Double support time</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>Changes in double support time (s) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cadence</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>Changes in cadence (steps/minute) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Heart rate</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>using a chest strap device which will be monitored during the gait measurement</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived effort</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>assessed using Borg Category-Ratio (CR) scale (0 = No effort, 10 = Maximal effort) to evaluate the work tasks conducted during the pre- and post-tests.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity levels</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>assessed using a questionnaire (The International Physical Activity Questionnaire) to determine the kind and level of the physical activity performed within the past 7 days. The questionnaire will be applied at baseline and every week for the entire duration of the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reporting of exoskeleton-use during the 12-weeks intervention</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>assessed using yes/ no, metric and open-ended questions on usage: Q1: &quot;Did you wear the device this week?&quot;, Q2: &quot;How much did you wear the device every day? &quot; Q3: &quot;What activities did you predominately performed with the device?&quot;. The questionnaire will be applied at baseline and every week for the entire duration of the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Wearability</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>assessed using yes/ no and open-ended questions on ease/discomfort of wearing the device: Q1: &quot;Did you have any technical problems with the device broken/stuck?&quot; Q2: &quot;Did you have any physical problems with the device pain/discomfort?&quot; Q3: &quot;Did see or feel any improvements in your ability to walk?&quot; 4. &quot;How would you describe your experience so far in few words? &quot;. The questionnaire will be applied at baseline and every week for the entire duration of the intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Qualitative data</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial.]</time_frame>
      <description>Assessed using a semi-constructed interview with yes/ no and open-ended questions on the overall experience of using the device.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>of incorporating a passive assistive bilateral exoskeleton into the daily routine of pre-frail adults for a duration of 12-weeks using the acceptability questionnaire that has a 7-point Liker scale ranging from &quot;very unacceptable&quot; to &quot;very acceptable&quot;.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Life quality</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>assessed using a questionnaire the EQ-5D-5L which evaluates five dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety, and discomfort) at five severity levels ranging from no effect/symptom to slightly, moderate, severe, and extreme.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Age</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>will be collected as descriptive statistics and for the inclusion criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>will be assessed by collecting weigth and height.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Frailty</measure>
      <time_frame>Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial</time_frame>
      <description>assessed using a questionnaire the Tilburg Frailty Index which evaluates frailty levels for the inclusion criteria.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Pre-frail Senior Adults</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>30 minutes of daily wearing an exoskeleton for 12-weeks</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Exoskeleton</intervention_name>
      <description>Use a passive assistive hip exoskeleton (alQ, Imasen Electrical Industrial Co., Ltd.) for 30 minutes daily during moderate to intensive activities over a period of 12-weeks. The exoskeleton is designed to aid hip flexion and as such its primary role is to improve gait by increasing step length and improving speed. The amount of time the exoskeleton has been used will be weekly monitored through phone calls and two gait sessions will be conducted to measure the development.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  score of ≤ 5 on the Tilburg Frailty index&#xD;
  &#xD;
            -  able to walk independently without walking aids.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  score of &gt;6 on the Tilburg Frailty index&#xD;
  &#xD;
            -  uncorrected visual or hearing impairments&#xD;
  &#xD;
            -  Vestibular dysfunctions&#xD;
  &#xD;
            -  current use of walking aids.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cristina-Ioana Pirscoveanu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Aalborg University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cristina-Ioana Pirscoveanu</last_name>
      <phone>+4551890406</phone>
      <email>civ@hst.aau.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pascal Madeleine, Professor</last_name>
      <phone>+4599408833</phone>
      <email>pm@hst.aau.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Aalborg University</name>
        <address>
          <city>Gistrup</city>
          <state>Nordjylland</state>
          <zip>9210</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Cristina-Ioana Pirscoveanu, Msc</last_name>
        <phone>+4551890406</phone>
        <email>civ@hst.aau.dk</email>
      </contact>
      <contact_backup>
        <last_name>Pascal Madeleine, Professor</last_name>
        <phone>+4599408833</phone>
        <email>pm@hst.aau.dk</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <link>
      <url>https://www.sst.dk/-/media/English/Publications/2020/Forebyggelsepakke-fysisk-aktivitet-(Engelsk)/Health-promotion-package-on-physical-activity.ashx?sc_lang=en&amp;hash=F3BB1EEB328D772F7DD3A4DF4E9B6866</url>
      <description>Danish Health Authority. Health promotion package - Physical activity. (2018).</description>
    </link>
    <link>
      <url>https://www.danskernessundhed.dk</url>
      <description>Sundhedsstyrelsen. Danskernes Sundhed - Tal fra Den Nationale Sundhedsprofil</description>
    </link>
    <link>
      <url>https://www.euro.who.int/__data/assets/pdf_file/0008/382373/denmark-eng.pdf</url>
      <description>World Health Organization. Denmark Physical activity factsheet 2018</description>
    </link>
    <link>
      <url>https://ieeexplore.ieee.org/stamp/stamp.jsp?arnumber=8782586</url>
      <description>Zhang et al., 2019 - Design and Control of a Series Elastic Actuator With Clutch for Hip Exoskeleton for Precise Assistive Magnitude and Timing Control and Improved Mechanical Safety</description>
    </link>
    <reference>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aalborg University</investigator_affiliation>
      <investigator_full_name>Cristina-Ioana Pirscoveanu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>exoskeleton</keyword>
    <keyword>aging</keyword>
    <keyword>walking</keyword>
    <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/NCT06041100
  org study id: AAU2-LBK1083
  nct id: NCT06041100
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Despite the huge popularity exoskeletons have gained in the past years and the benefits that
        they have shown to provide to users, there are still many aspects of wearing an exoskeleton
        that have yet to be determined. Therefore, the main objective of this study is to evaluate
        the feasibility using the acceptability of incorporating a passive assistive bilateral
        exoskeleton into the daily routine of pre-frail adults for a duration of 12-weeks. The second
        aim of the study is to determine whether this effect can be sustained even after a period of
        6-weeks following the cessation of usage.
  Despite the high benefits of performing physical activity in terms of physical and cognitive
        function, between 27-38% of Danish older adults do not meet the required physical activity
        recommendations. Due to the longer life expectancy, the increasingly older population will
        face gait disorders. These gait disorders will affect their motor and cognitive functions,
        and impair the performance of daily physical activity and overall quality of life. Frailty is
        one of the most frequent aging-related deficits observed in older adults, often characterized
        by three of the following criteria: unintentional weight loss >4.5 kg within the last year,
        exhaustion, loss or slower mobility, loss of grip strength, and low physical activity.
        However, pre-frail adults may present some of the aforementioned criteria and a score of ≤5
        on the Tilburg Frailty Indicator. Therefore, there is an increasing need to provide the aging
        population with devices capable of promoting physical activity and independent living.
        Exoskeletons have been shown to facilitate physical activity in the older adult population by
        improving metabolic costs, increasing walking speed, and preventing falls. However, whether
        these benefits are only temporary, or can be maintained over a longer period, remains to be
        determined. Therefore, it is of pivotal importance to assess the long-term effects of
        exoskeletons, in terms of mobility, within the older adult population.
  
        The use of external mechanical walking devices started in the late 1890s. However, only in
        the past two decades have gait-assisting exoskeletons, with increased human performance
        capability, gained popularity. Exoskeletons have been shown to reduce metabolic cost, and
        fatigue onset and increase walking velocity. Currently on the market, there are several
        lower-limb exoskeletons that target older populations and people with gait and neurological
        disabilities which are designed to enhance walking performance and reduce the muscle
        activation required during walking activities. Wearing gait-assisting exoskeletons can
        provide instant ease, delay fatigue onset, increase social engagement, and support
        rehabilitation to recover normal walking capabilities. The effects of hip exoskeletons have
        been previously investigated in terms of quality of life and improvement of gait performance.
        However, the effect of long-term use has yet to be assessed. Hence, this study aims to
        evaluate the impact of extended usage of a non-invasive passive hip exoskeleton on the
        quality of life of older adults. This will be achieved by analyzing the spatiotemporal gait
        characteristics in a feasibility study conducted over a 12-week period of consistent device
        usage. Additionally, the study aims to ascertain the persistence of these effects for a
        duration of 6 weeks post-usage.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All participants will complete three test sessions:
  An initial assessment (baseline)
  A 4-week assessment and
  A 12-week assessment.
  Around 8-10 participants will be invited for a follow-up assessment 6-weeks post after the trial has ended.
  All participants will be instructed to wear the device 30 minutes daily during moderate to intensive physical activities. They will be required to provide a weekly overview of their usage and experience with the device.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Walking speed
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: Changes in speed (m/s) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).
  measure: Step length
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: Changes in step length (cm) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).
  measure: Double support time
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: Changes in double support time (s) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).
  measure: Cadence
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: Changes in cadence (steps/minute) will be assessed 1) with and without the exoskeleton 2) will be assessed through 1) a 6-minutes' walk test and 2) a short performance battery test using an inertial measurement unit (IMU) located on the fifth lumbar vertebra (L5).
  measure: Heart rate
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: using a chest strap device which will be monitored during the gait measurement
  measure: Perceived effort
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: assessed using Borg Category-Ratio (CR) scale (0 = No effort, 10 = Maximal effort) to evaluate the work tasks conducted during the pre- and post-tests.
  measure: Physical activity levels
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: assessed using a questionnaire (The International Physical Activity Questionnaire) to determine the kind and level of the physical activity performed within the past 7 days. The questionnaire will be applied at baseline and every week for the entire duration of the intervention.
  measure: Self-reporting of exoskeleton-use during the 12-weeks intervention
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: assessed using yes/ no, metric and open-ended questions on usage: Q1: "Did you wear the device this week?", Q2: "How much did you wear the device every day? " Q3: "What activities did you predominately performed with the device?". The questionnaire will be applied at baseline and every week for the entire duration of the intervention.
  measure: Wearability
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: assessed using yes/ no and open-ended questions on ease/discomfort of wearing the device: Q1: "Did you have any technical problems with the device broken/stuck?" Q2: "Did you have any physical problems with the device pain/discomfort?" Q3: "Did see or feel any improvements in your ability to walk?" 4. "How would you describe your experience so far in few words? ". The questionnaire will be applied at baseline and every week for the entire duration of the intervention.
  measure: Qualitative data
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial.]
  description: Assessed using a semi-constructed interview with yes/ no and open-ended questions on the overall experience of using the device.
  measure: Acceptability
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: of incorporating a passive assistive bilateral exoskeleton into the daily routine of pre-frail adults for a duration of 12-weeks using the acceptability questionnaire that has a 7-point Liker scale ranging from "very unacceptable" to "very acceptable".
  measure: Life quality
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: assessed using a questionnaire the EQ-5D-5L which evaluates five dimensions (mobility, self-care, usual activities, pain and discomfort, anxiety, and discomfort) at five severity levels ranging from no effect/symptom to slightly, moderate, severe, and extreme.
  measure: Age
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: will be collected as descriptive statistics and for the inclusion criteria.
  measure: BMI
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: will be assessed by collecting weigth and height.
  measure: Frailty
  time frame: Pre-test (baseline) initial, 4-weeks evaluation, 12-weeks (end of intervention) and 6-weeks post-test subsequent the 12- week intervention trial
  description: assessed using a questionnaire the Tilburg Frailty Index which evaluates frailty levels for the inclusion criteria.
  arm group label: Intervention
  arm group type: Experimental
  description: 30 minutes of daily wearing an exoskeleton for 12-weeks
  intervention type: Device
  intervention name: Exoskeleton
  description: Use a passive assistive hip exoskeleton (alQ, Imasen Electrical Industrial Co., Ltd.) for 30 minutes daily during moderate to intensive activities over a period of 12-weeks. The exoskeleton is designed to aid hip flexion and as such its primary role is to improve gait by increasing step length and improving speed. The amount of time the exoskeleton has been used will be weekly monitored through phone calls and two gait sessions will be conducted to measure the development.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 85 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cristina-Ioana Pirscoveanu
  role: Principal Investigator
  affiliation: Aalborg University
  last name: Cristina-Ioana Pirscoveanu
  phone: +4551890406
  email: civ@hst.aau.dk
  last name: Pascal Madeleine, Professor
  phone: +4599408833
  email: pm@hst.aau.dk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Denmark
  url: https://www.sst.dk/-/media/English/Publications/2020/Forebyggelsepakke-fysisk-aktivitet-(Engelsk)/Health-promotion-package-on-physical-activity.ashx?sc_lang=en&hash=F3BB1EEB328D772F7DD3A4DF4E9B6866
  description: Danish Health Authority. Health promotion package - Physical activity. (2018).
  url: https://www.danskernessundhed.dk
  description: Sundhedsstyrelsen. Danskernes Sundhed - Tal fra Den Nationale Sundhedsprofil
  url: https://www.euro.who.int/__data/assets/pdf_file/0008/382373/denmark-eng.pdf
  description: World Health Organization. Denmark Physical activity factsheet 2018
  url: https://ieeexplore.ieee.org/stamp/stamp.jsp?arnumber=8782586
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  PMID: 30872237
  responsible party type: Principal Investigator
  investigator affiliation: Aalborg University
  investigator full name: Cristina-Ioana Pirscoveanu
  investigator title: Principal Investigator
  sharing ipd: No