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
About this trial
This is an interventional basic science trial for Movement Disorders
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
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
NCT ID
NCT04591132
First Posted
May 29, 2020
Last Updated
October 15, 2020
Sponsor
University College, London
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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