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/NCT05986643</url>
    </required_header>
    <id_info>
      <org_study_id>0903</org_study_id>
      <secondary_id>324686</secondary_id>
      <nct_id>NCT05986643</nct_id>
    </id_info>
    <brief_title>Brain Training to Improve Balance in Parkinson's Disease</brief_title>
    <official_title>Using Biofeedback During Exergaming to Attenuate Alpha Oscillations to Improve Postural Control in People Living With Parkinson's.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Leicester</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Exeter</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Nottingham</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Plymouth</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>European Bioinformatics Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Leicester</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>
        People living with Parkinson's (PwP) rank balance problems amongst the most disabling&#xD;
        symptom. Over time, balance function continues to decline and PwP go on to fall, affecting&#xD;
        between 45-68% of PwP. Falling directly impacts upon the individuals' quality of life (QoL),&#xD;
        as it prevents patients from doing everyday activities, and places PwP at greater risk of&#xD;
        other medical problems, such as fractures.&#xD;
  &#xD;
        New treatments are urgently needed to improve balance and reduce falls in order to improve&#xD;
        QoL for PwP. The aim of this project is to achieve these goals by using exercise to alter&#xD;
        brain activity. Supporting our idea, are previous studies that show both exercise alone as&#xD;
        well as changing brain activity at rest via visual feedback (similar to how breathing can be&#xD;
        controlled to lower blood pressure), can be used to rehabilitate balance. Here researchers&#xD;
        test the idea that better results can be achieved for PwP, if a specific exercise program is&#xD;
        used as the feedback to change brain activity.&#xD;
  &#xD;
        PwP will be assigned randomly into 2 groups, one receiving the exergaming physical therapy&#xD;
        (PT) alone with a placebo feedback and, the second group will be required to change brain&#xD;
        activity using exercise feedback to change brain activity.&#xD;
  &#xD;
        Each intervention will be performed 3 times/week with each session lasting 1⁄2 an hour, for&#xD;
        12 consecutive weeks. Participants are expected to attend 5 sessions over each fortnight.&#xD;
        Assessments of balance will be made before and after all three treatments. This will allow us&#xD;
        to measure any improvements and compare the 2 different methods to see which one improves&#xD;
        balance the most in PwP.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a multi-centre centre study with University of Leicester and DeMontfort University&#xD;
        being research sites. NHS organisations will be PIC sites where participants will be&#xD;
        identified from. No medical data or access to patient medical records will be made. A PIC&#xD;
        mNCA will be in place with NHS organisations.&#xD;
  &#xD;
        For the design of the study, the investigators will adopt a double-blinded randomised&#xD;
        clinical trial. This means that patients will not know their group allocation and the&#xD;
        research associate that will be analysing the data will also not know what treatment the&#xD;
        patient received.&#xD;
  &#xD;
        Participants will be allocated into either group 1 or 2. Participants in both groups will&#xD;
        both perform the exergame rehabilitation. The exergame, delivered in virtual reality,&#xD;
        involves travelling down a road (to give optic flow) whilst dodging balls that move towards&#xD;
        the participant by either shifting their body either to the left or right. Patients are also&#xD;
        be instructed to stand still and catch stars that appear, and these will be used to score&#xD;
        points and are associated with reward, ensuring motivation.&#xD;
  &#xD;
        This exergame has been specifically designed to combine aspects of movement and balance&#xD;
        control, body position, aerobic fitness, strengthening of core muscles and elements of&#xD;
        co-ordination and speed.&#xD;
  &#xD;
        The difference between the two groups will be the neuro-feedback provided during the&#xD;
        performance of the exercise game. That is, group 1 will receive real feedback of brain&#xD;
        activity whilst group 2 will receive a placebo which is called SHAM feedback. This&#xD;
        corresponds to a random recording that has no association/correlation with on-going brain&#xD;
        (EEG) activity. All participants will be randomly assigned a unique key code via a random&#xD;
        computer generator, this will be facilitated by the Data Monitoring and Ethics committee. The&#xD;
        research technician, that will perform the analysis of the data, will not be privy to&#xD;
        particular intervention of interest. After the random allocation, but before the&#xD;
        intervention, all participants will receive a familiarisation procedure for their allocation.&#xD;
        Once the participants have successfully undergone the eligibility screening (see section&#xD;
        below for details), participants will be randomly allocated to one of two groups. The&#xD;
        research team will then conduct the familiarisation sessions before proceeding to the&#xD;
        pre-intervention assessment (limit of stability at baseline). This will be followed by the&#xD;
        12-week training program (that requires attendance at 30 1/2hr sessions over the course of&#xD;
        three months. This will be followed by the 12 week (end of program) post-intervention&#xD;
        assessment to measure the limit of stability, and a further single follow-up at 6 months to&#xD;
        asses for long-term retention of any benefits. The 12-week post-intervention testing sessions&#xD;
        will occur within 72 hours, but no less than 24 hours following the preceding training&#xD;
        session. For the Pre-and Post- assessments: this will include the : (i) the Limits of&#xD;
        Stability test, (ii) Sensory Organisation Test, (iii) Parkinson's Disease Questionnaire, (iv)&#xD;
        Berg Balance Scale, (v) Section III of UPDRS, (vi) mBEST, (vii) 6 Metre WalkTest, (viii) 4&#xD;
        Square Step Test, and (ix) the Daily Activities Questionnaire. All of the aforementioned&#xD;
        measures are openly available and do not require any licenses/permission to use. Accordingly,&#xD;
        there will not be any need to share data with the license holders.&#xD;
  &#xD;
        VISIT 1:&#xD;
  &#xD;
        In the first visit the research team will firstly ensure that the PLwP meet the eligibility&#xD;
        criteria and that none of the exclusion criteria apply. Only those eligible will be randomly&#xD;
        allocated to one or two groups, and the research team will measure using posturography and&#xD;
        walking assessments to obtain a baseline balance score. The research team will also complete&#xD;
        questionnaires, including the Parkinson's Disease Questionnaire, Berg Balance Scale, Section&#xD;
        III of the UPDRS, and Daily Activities Questionnaires. The research team will also take a&#xD;
        brief medical history. This initial visit will take place at the balance testing laboratory&#xD;
        at DeMonfort University.&#xD;
  &#xD;
        12 WEEK TRAINING PROGRAMME: During the 12-week training programme, participants will be asked&#xD;
        to attend the balance laboratory at the University of Leicester, where either the exergame&#xD;
        activity with feedback from brain activity or no feedback will be performed. These training&#xD;
        sessions will last half an hour in total, and it is expected patients to complete 5 sessions&#xD;
        over the course of a 2- week period. An online booking system will be used to manage the&#xD;
        sessions. Participants will be allowed to miss a total of 6 sessions in total across the&#xD;
        whole of the 3-month intervention program. Missing any more that this would compromise the&#xD;
        integrity of the data.&#xD;
  &#xD;
        POST INTERVENTION:&#xD;
  &#xD;
        A post-intervention will be arranged immediately at the end of the training programme, then&#xD;
        again at 3 and 6 months respectively. During these post-interventions, measurements will be&#xD;
        taken from using the posturography and walking assessments to obtain a baseline balance&#xD;
        score. Questionnaires will be completed, including the Parkinson's Disease Questionnaire,&#xD;
        Berg Balance Scale, Section III of the UPDRS, and Daily Activities Questionnaires. A brief&#xD;
        medical history will be taken again. These visits will take place at the balance testing&#xD;
        laboratory at DeMonfort University.&#xD;
  &#xD;
        INTERVIEWFor the optional part of the study, an interview will be arranged to take the&#xD;
        patients' and Carers views on the accessibility and tolerability of these interventions,&#xD;
        these will take place roughly 2 weeks at the end of the final training session. An encrypted&#xD;
        voice recorder will be used. Participant ID will be mentioned at the beginning of the&#xD;
        recording so that participants remain anonymous. Recordings will be stored in a secure&#xD;
        environment at the University before the recordings are transferred to university computers.&#xD;
        Recordings will be immediately deleted as soon as the recordings have been transferred. The&#xD;
        research team or an external transcribing company (a confidentiality agree will be in place),&#xD;
        will transcribe the recordings for analysing.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2026</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>To maintain the gold standard approach of complete randomisation but we have tightened the inclusion criteria to stipulate both a history of falls and freezing of gait (FoG).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Random computer generation</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Balance Scores</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in balance scores using The Limits of stability (LOS) test. This dynamic balance score is measured using a commercially available system (Bertec CDP/IVRTM (Interacoustics)).The participants will be asked to stand barefoot on the centre of the force platform, and will be support by a secure harness throughout to prevent falls. The assessment requires each participant to move their centre of pressure (COP) towards an intended target in the following order: forward, forward right, right, backward right, backward, backward left, left and forward left. Movement velocity (degrees per second), maximal excursion (greatest distance [cm] achieved towards the intended target/maximal distance of target [cm]) and directional control ([the amount of intended movement - amount of extraneous movement)/amount of intended movement] × 100) will be measured, representing the maximum distance an individual can intentionally sway without losing balance or needing to take a step.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sensory Organisation Scores</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes in the Sensory Organisation test scores, calculated by an interval scale, with 100 indicating no sway and 0 indicating an uncompleted trial.&#xD;
  This task comprises six different sensory conditions in quiet stance and measures the COP path in centimetres. The test progressively becomes harder by either distracting or removing visual and/or proprioceptive feedback. During sway-referenced conditions, erroneous sensory information is presented to the participant while the force platform measures the participant's ability to compensate by using other senses to maintain balance. The following sensory conditions will be used:&#xD;
  Condition 1: Eyes open and fixed support&#xD;
  Condition 2: Eyes closed and fixed support&#xD;
  Condition 3: Eyes open sway-referenced and support sway-referenced&#xD;
  Condition 4: Eyes open and support sway referenced&#xD;
  Condition 5: Eyes closed and support sway-referenced&#xD;
  Condition 6: Eyes open and sway-referenced with support sway-referenced</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Daily Life Scores</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes of activities in daily life.&#xD;
  The investigators will use a validated questionnaire to asses functional improvements in activities associated with everyday living.&#xD;
  Activities of Daily Living Questionnaire (ADLQ) - A questionnaire aimed for use with patients diagnosed with cognitive impairments, which assesses function in ADL tasks across 6 areas of life.&#xD;
  A set of four descriptions of different competence levels; scores range from 0 to 3 where higher scores indicate greater impairment. A fifth response option, &quot;don't know/has never done&quot; is also available, and if this option is selected, the item is excluded from scoring.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Exergame &amp; Neurofeedback</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Six 5 minutes sets of participants standing on a balance board within virtual environment playing the exergame and receiving real neurofeedback with 1 minute rest between each set.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Exergame &amp; SHAM Feedback</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Six 5 minutes sets of participants standing on a balance board within virtual environment playing the exergame and receiving SHAM neurofeedback with 1 minute rest between each set.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exergame+Neurofeedback</intervention_name>
      <description>Electroencephalography (EEG) is a device that measures the electrical activity of the brain (brain waves). There are several frequencies of brain waves when we are awake; alpha (medium), beta (fast), and theta (slow). Alpha frequencies of brain activity are linked to maintaining balance, with more alpha activity being associated with poorer balance. EEG neurofeedback treatment involves placing electrodes on a person's head to monitor and change brain activity by giving cued audio or visual feedback. It has been used in PwP to show improvements in balance and walking. Other preliminary research in PwP has shown that exercise can also improve balance.</description>
      <arm_group_label>Exergame &amp; Neurofeedback</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Exergame [alone]</intervention_name>
      <description>The exergame, delivered in virtual reality, involves travelling down a road (to give optic flow) whilst dodging balls that move towards the participant by either shifting their body either to the left or right. They are also be instructed to stand still and catch stars that appear and these will be used to score points and are associated with a monetary reward, ensuring motivation.&#xD;
  This group will receive SHAM feedback.</description>
      <arm_group_label>Exergame &amp; SHAM Feedback</arm_group_label>
      <other_name>Exergame</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          People with Parkinson with mild-moderate disease and severe disability (but able to stand&#xD;
          and walk unaided (Hoehn and Yahr stage ≤4) be eligible if:&#xD;
  &#xD;
            -  in everyday life, they do less than the recommended aerobic exercise for older adults&#xD;
               (i.e., vigorous exercise done &lt;3 times per week, 20 min per session; or moderate&#xD;
               exercise done &lt;5 times per week, 30 min per session).&#xD;
  &#xD;
            -  they have experienced at least one fall and one episode of freezing of gait in the&#xD;
               past year.&#xD;
  &#xD;
            -  they are taking stable dopaminergic pharmacotherapy (stable dose for at least 1 month)&#xD;
               or are still without treatment and not expected to start treatment within the next 3&#xD;
               months.&#xD;
  &#xD;
          As long as all criteria are met - we will not impose any lower (assuming they are adults)&#xD;
          or upper age limit for recruitment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  severe lower limb motor impairments and/or requirement of a walking aid or wheelchair&#xD;
  &#xD;
            -  previously diagnosed with stroke or dementia&#xD;
  &#xD;
            -  having metal implants in the head (i.e. deep brain stimulator or aneurysm clips)&#xD;
  &#xD;
            -  any other known medical, mental health, or physical condition which may interfere with&#xD;
               balance.&#xD;
  &#xD;
            -  patients on beta-blocking agents or antipsychotics&#xD;
  &#xD;
            -  patients with other neurological, orthopaedic, or cardiac co-morbidities that make&#xD;
               them unfit to do exercise or interferes with balance and cognitive functions required&#xD;
               to participate in this study&#xD;
  &#xD;
            -  patients with psychiatric diseases diagnosed in the past year by a psychiatrist&#xD;
  &#xD;
            -  patients with dementia&#xD;
  &#xD;
            -  those unable to tolerate the exergame task.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qadeer Arshad</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Leicester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yasmin Godhania</last_name>
      <phone>0116 373 6039</phone>
      <email>RGOsponsor@leicester.ac.uk</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Balance</keyword>
    <keyword>Gait</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We plan to share via open access platforms the study protocol and statistical analysis approach before commencing the trial.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Before the trial commences</ipd_time_frame>
      <ipd_access_criteria>No criteria</ipd_access_criteria>
    </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/NCT05986643
  org study id: 0903
  secondary id: 324686
  nct id: NCT05986643
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  People living with Parkinson's (PwP) rank balance problems amongst the most disabling
        symptom. Over time, balance function continues to decline and PwP go on to fall, affecting
        between 45-68% of PwP. Falling directly impacts upon the individuals' quality of life (QoL),
        as it prevents patients from doing everyday activities, and places PwP at greater risk of
        other medical problems, such as fractures.
  
        New treatments are urgently needed to improve balance and reduce falls in order to improve
        QoL for PwP. The aim of this project is to achieve these goals by using exercise to alter
        brain activity. Supporting our idea, are previous studies that show both exercise alone as
        well as changing brain activity at rest via visual feedback (similar to how breathing can be
        controlled to lower blood pressure), can be used to rehabilitate balance. Here researchers
        test the idea that better results can be achieved for PwP, if a specific exercise program is
        used as the feedback to change brain activity.
  
        PwP will be assigned randomly into 2 groups, one receiving the exergaming physical therapy
        (PT) alone with a placebo feedback and, the second group will be required to change brain
        activity using exercise feedback to change brain activity.
  
        Each intervention will be performed 3 times/week with each session lasting 1⁄2 an hour, for
        12 consecutive weeks. Participants are expected to attend 5 sessions over each fortnight.
        Assessments of balance will be made before and after all three treatments. This will allow us
        to measure any improvements and compare the 2 different methods to see which one improves
        balance the most in PwP.
  This is a multi-centre centre study with University of Leicester and DeMontfort University
        being research sites. NHS organisations will be PIC sites where participants will be
        identified from. No medical data or access to patient medical records will be made. A PIC
        mNCA will be in place with NHS organisations.
  
        For the design of the study, the investigators will adopt a double-blinded randomised
        clinical trial. This means that patients will not know their group allocation and the
        research associate that will be analysing the data will also not know what treatment the
        patient received.
  
        Participants will be allocated into either group 1 or 2. Participants in both groups will
        both perform the exergame rehabilitation. The exergame, delivered in virtual reality,
        involves travelling down a road (to give optic flow) whilst dodging balls that move towards
        the participant by either shifting their body either to the left or right. Patients are also
        be instructed to stand still and catch stars that appear, and these will be used to score
        points and are associated with reward, ensuring motivation.
  
        This exergame has been specifically designed to combine aspects of movement and balance
        control, body position, aerobic fitness, strengthening of core muscles and elements of
        co-ordination and speed.
  
        The difference between the two groups will be the neuro-feedback provided during the
        performance of the exercise game. That is, group 1 will receive real feedback of brain
        activity whilst group 2 will receive a placebo which is called SHAM feedback. This
        corresponds to a random recording that has no association/correlation with on-going brain
        (EEG) activity. All participants will be randomly assigned a unique key code via a random
        computer generator, this will be facilitated by the Data Monitoring and Ethics committee. The
        research technician, that will perform the analysis of the data, will not be privy to
        particular intervention of interest. After the random allocation, but before the
        intervention, all participants will receive a familiarisation procedure for their allocation.
        Once the participants have successfully undergone the eligibility screening (see section
        below for details), participants will be randomly allocated to one of two groups. The
        research team will then conduct the familiarisation sessions before proceeding to the
        pre-intervention assessment (limit of stability at baseline). This will be followed by the
        12-week training program (that requires attendance at 30 1/2hr sessions over the course of
        three months. This will be followed by the 12 week (end of program) post-intervention
        assessment to measure the limit of stability, and a further single follow-up at 6 months to
        asses for long-term retention of any benefits. The 12-week post-intervention testing sessions
        will occur within 72 hours, but no less than 24 hours following the preceding training
        session. For the Pre-and Post- assessments: this will include the : (i) the Limits of
        Stability test, (ii) Sensory Organisation Test, (iii) Parkinson's Disease Questionnaire, (iv)
        Berg Balance Scale, (v) Section III of UPDRS, (vi) mBEST, (vii) 6 Metre WalkTest, (viii) 4
        Square Step Test, and (ix) the Daily Activities Questionnaire. All of the aforementioned
        measures are openly available and do not require any licenses/permission to use. Accordingly,
        there will not be any need to share data with the license holders.
  
        VISIT 1:
  
        In the first visit the research team will firstly ensure that the PLwP meet the eligibility
        criteria and that none of the exclusion criteria apply. Only those eligible will be randomly
        allocated to one or two groups, and the research team will measure using posturography and
        walking assessments to obtain a baseline balance score. The research team will also complete
        questionnaires, including the Parkinson's Disease Questionnaire, Berg Balance Scale, Section
        III of the UPDRS, and Daily Activities Questionnaires. The research team will also take a
        brief medical history. This initial visit will take place at the balance testing laboratory
        at DeMonfort University.
  
        12 WEEK TRAINING PROGRAMME: During the 12-week training programme, participants will be asked
        to attend the balance laboratory at the University of Leicester, where either the exergame
        activity with feedback from brain activity or no feedback will be performed. These training
        sessions will last half an hour in total, and it is expected patients to complete 5 sessions
        over the course of a 2- week period. An online booking system will be used to manage the
        sessions. Participants will be allowed to miss a total of 6 sessions in total across the
        whole of the 3-month intervention program. Missing any more that this would compromise the
        integrity of the data.
  
        POST INTERVENTION:
  
        A post-intervention will be arranged immediately at the end of the training programme, then
        again at 3 and 6 months respectively. During these post-interventions, measurements will be
        taken from using the posturography and walking assessments to obtain a baseline balance
        score. Questionnaires will be completed, including the Parkinson's Disease Questionnaire,
        Berg Balance Scale, Section III of the UPDRS, and Daily Activities Questionnaires. A brief
        medical history will be taken again. These visits will take place at the balance testing
        laboratory at DeMonfort University.
  
        INTERVIEWFor the optional part of the study, an interview will be arranged to take the
        patients' and Carers views on the accessibility and tolerability of these interventions,
        these will take place roughly 2 weeks at the end of the final training session. An encrypted
        voice recorder will be used. Participant ID will be mentioned at the beginning of the
        recording so that participants remain anonymous. Recordings will be stored in a secure
        environment at the University before the recordings are transferred to university computers.
        Recordings will be immediately deleted as soon as the recordings have been transferred. The
        research team or an external transcribing company (a confidentiality agree will be in place),
        will transcribe the recordings for analysing.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: To maintain the gold standard approach of complete randomisation but we have tightened the inclusion criteria to stipulate both a history of falls and freezing of gait (FoG).
  primary purpose: Treatment
  masking: Single (Investigator)
  masking description: Random computer generation
  measure: Balance Scores
  time frame: 12 weeks
  description: Changes in balance scores using The Limits of stability (LOS) test. This dynamic balance score is measured using a commercially available system (Bertec CDP/IVRTM (Interacoustics)).The participants will be asked to stand barefoot on the centre of the force platform, and will be support by a secure harness throughout to prevent falls. The assessment requires each participant to move their centre of pressure (COP) towards an intended target in the following order: forward, forward right, right, backward right, backward, backward left, left and forward left. Movement velocity (degrees per second), maximal excursion (greatest distance [cm] achieved towards the intended target/maximal distance of target [cm]) and directional control ([the amount of intended movement - amount of extraneous movement)/amount of intended movement] × 100) will be measured, representing the maximum distance an individual can intentionally sway without losing balance or needing to take a step.
  measure: Sensory Organisation Scores
  time frame: 12 weeks
  description: Changes in the Sensory Organisation test scores, calculated by an interval scale, with 100 indicating no sway and 0 indicating an uncompleted trial.
  This task comprises six different sensory conditions in quiet stance and measures the COP path in centimetres. The test progressively becomes harder by either distracting or removing visual and/or proprioceptive feedback. During sway-referenced conditions, erroneous sensory information is presented to the participant while the force platform measures the participant's ability to compensate by using other senses to maintain balance. The following sensory conditions will be used:
  Condition 1: Eyes open and fixed support
  Condition 2: Eyes closed and fixed support
  Condition 3: Eyes open sway-referenced and support sway-referenced
  Condition 4: Eyes open and support sway referenced
  Condition 5: Eyes closed and support sway-referenced
  Condition 6: Eyes open and sway-referenced with support sway-referenced
  measure: Daily Life Scores
  time frame: 12 weeks
  description: Changes of activities in daily life.
  The investigators will use a validated questionnaire to asses functional improvements in activities associated with everyday living.
  Activities of Daily Living Questionnaire (ADLQ) - A questionnaire aimed for use with patients diagnosed with cognitive impairments, which assesses function in ADL tasks across 6 areas of life.
  A set of four descriptions of different competence levels; scores range from 0 to 3 where higher scores indicate greater impairment. A fifth response option, "don't know/has never done" is also available, and if this option is selected, the item is excluded from scoring.
  arm group label: Exergame & Neurofeedback
  arm group type: Active Comparator
  description: Six 5 minutes sets of participants standing on a balance board within virtual environment playing the exergame and receiving real neurofeedback with 1 minute rest between each set.
  arm group label: Exergame & SHAM Feedback
  arm group type: Sham Comparator
  description: Six 5 minutes sets of participants standing on a balance board within virtual environment playing the exergame and receiving SHAM neurofeedback with 1 minute rest between each set.
  intervention type: Behavioral
  intervention name: Exergame+Neurofeedback
  description: Electroencephalography (EEG) is a device that measures the electrical activity of the brain (brain waves). There are several frequencies of brain waves when we are awake; alpha (medium), beta (fast), and theta (slow). Alpha frequencies of brain activity are linked to maintaining balance, with more alpha activity being associated with poorer balance. EEG neurofeedback treatment involves placing electrodes on a person's head to monitor and change brain activity by giving cued audio or visual feedback. It has been used in PwP to show improvements in balance and walking. Other preliminary research in PwP has shown that exercise can also improve balance.
  arm group label: Exergame & Neurofeedback
  intervention type: Behavioral
  intervention name: Exergame [alone]
  description: The exergame, delivered in virtual reality, involves travelling down a road (to give optic flow) whilst dodging balls that move towards the participant by either shifting their body either to the left or right. They are also be instructed to stand still and catch stars that appear and these will be used to score points and are associated with a monetary reward, ensuring motivation.
  This group will receive SHAM feedback.
  arm group label: Exergame & SHAM Feedback
  other name: Exergame
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Qadeer Arshad
  role: Principal Investigator
  affiliation: University of Leicester
  last name: Yasmin Godhania
  phone: 0116 373 6039
  email: RGOsponsor@leicester.ac.uk
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: Yes
  ipd description: We plan to share via open access platforms the study protocol and statistical analysis approach before commencing the trial.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Before the trial commences
  ipd access criteria: No criteria