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Technology-based Analysis of Movement Disorders

Primary Purpose

Movement Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
kinematic analysis
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Movement Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of parkinsonism and/or dystonia and/or tremor due to:

    1. idiopatic parkinson's disease
    2. atypical parkinsonism
    3. sporadic or inherited/genetic dystonia
    4. young-onset Parkinson's disease
    5. Ataxia syndrome
    6. Choereic syndrome
    7. Essential tremor
    8. Dystonic tremor
  • 18 to 80 years of age
  • Willing and able to provide informed consent
  • able to walk unassisted

Exclusion Criteria:

  • Change in pharmacological therapy in the last 3 months.
  • Participated in a clinical drug trial up to 3 months before inclusion into the present study
  • Orthopaedical comorbidities affecting gait or posture.
  • Cognitive deficit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    kinematic analysis

    Arm Description

    each patient with a diagnosis of parkinsonism, ataxia, chorea, dystonia or tremor will be asked to perform some motor tasks routinely used in clinical evaluation wearing inertial sensors.

    Outcomes

    Primary Outcome Measures

    gait metrics
    gait cycles measures (step length, phase duration, number of steps) practice of technology based objective measures of motor performances in patients affected by different movement disorders, to objectively evaluate the disease burden, the efficacy of therapeutic interventions and having a deeper phenotyping of motor disabilities.
    tremor peak frequence
    fourier analysis for peak frequence of tremor
    neck ROM
    range of motion of the neck in x,y and z axis
    bradykinesia evaluation
    amplitude of repeated limb movements over time

    Secondary Outcome Measures

    correlation with UPDRS gait Item
    correlation of gait metrics with UPDRS gait score included.

    Full Information

    First Posted
    May 29, 2020
    Last Updated
    October 15, 2020
    Sponsor
    University College, London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04591132
    Brief Title
    Technology-based Analysis of Movement Disorders
    Official Title
    Technology-based Analysis of Movement Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2020 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University College, London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objectives: To generate pilot data to investigate the feasibility and the potential use in clinical practice of technology based objective measures of motor performances in patients affected by different movement disorders. To correlate kinematics findings with demographic and clinical details. Trial design and methods: Participants enrolled in prof. Bhatia's movement disorders clinic, will be classifies according to the main movement disorder, specifically, tremor, parkinsonism, dystonia, chorea, ataxia. In the study visit (one day only), they will undergo a clinical evaluation using the appropriate clinical scales (respectively, Fahn-Tolosa-Marin tremor rating scale, MDS-UPDRS Part III, Toronto Western Spasmodic Torticollis Rating Scale 2, Unified Hungtington Disease Rating scale and Scale for the Assessment and Rating of Ataxia) and a kinematic evaluation, using wearables and an infra-red and LED markers system. Then the protocol is concluded and they will continue the routine clinical follow-up

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Movement Disorders

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    kinematic analysis
    Arm Type
    Experimental
    Arm Description
    each patient with a diagnosis of parkinsonism, ataxia, chorea, dystonia or tremor will be asked to perform some motor tasks routinely used in clinical evaluation wearing inertial sensors.
    Intervention Type
    Device
    Intervention Name(s)
    kinematic analysis
    Intervention Description
    motor tasks appropriate for each diagnosis will be recorder with wearable inertial sensors
    Primary Outcome Measure Information:
    Title
    gait metrics
    Description
    gait cycles measures (step length, phase duration, number of steps) practice of technology based objective measures of motor performances in patients affected by different movement disorders, to objectively evaluate the disease burden, the efficacy of therapeutic interventions and having a deeper phenotyping of motor disabilities.
    Time Frame
    up to 6 weeks after enrolment
    Title
    tremor peak frequence
    Description
    fourier analysis for peak frequence of tremor
    Time Frame
    up to 6 weeks after enrolment
    Title
    neck ROM
    Description
    range of motion of the neck in x,y and z axis
    Time Frame
    up to 6 weeks after enrolment
    Title
    bradykinesia evaluation
    Description
    amplitude of repeated limb movements over time
    Time Frame
    up to 6 weeks after enrolment
    Secondary Outcome Measure Information:
    Title
    correlation with UPDRS gait Item
    Description
    correlation of gait metrics with UPDRS gait score included.
    Time Frame
    up to 6 weeks after enrolment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of parkinsonism and/or dystonia and/or tremor due to: idiopatic parkinson's disease atypical parkinsonism sporadic or inherited/genetic dystonia young-onset Parkinson's disease Ataxia syndrome Choereic syndrome Essential tremor Dystonic tremor 18 to 80 years of age Willing and able to provide informed consent able to walk unassisted Exclusion Criteria: Change in pharmacological therapy in the last 3 months. Participated in a clinical drug trial up to 3 months before inclusion into the present study Orthopaedical comorbidities affecting gait or posture. Cognitive deficit
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    kailash P Bhatia
    Phone
    020 3448 4229
    Email
    k.bhatia@ucl.ac.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    giulia di lazzaro
    Phone
    02034484229
    Email
    giulia.dilazzaro@nhs.net

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Technology-based Analysis of Movement Disorders

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