Technology-based Analysis of Movement Disorders

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

Study Overview

• Status: Not yet recruiting
• Conditions: Movement Disorders
• Intervention / Treatment: Device: kinematic analysis

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: kailash P Bhatia; Phone Number: 020 3448 4229; Email: k.bhatia@ucl.ac.uk
• Study Contact Backup: Name: giulia di lazzaro; Phone Number: 02034484229; Email: giulia.dilazzaro@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: kinematic analysis; 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.	Device: kinematic analysis; motor tasks appropriate for each diagnosis will be recorder with wearable inertial sensors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 6 weeks after enrolment
tremor peak frequence	fourier analysis for peak frequence of tremor	up to 6 weeks after enrolment
neck ROM	range of motion of the neck in x,y and z axis	up to 6 weeks after enrolment
bradykinesia evaluation	amplitude of repeated limb movements over time	up to 6 weeks after enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation with UPDRS gait Item	correlation of gait metrics with UPDRS gait score included.	up to 6 weeks after enrolment

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders
• Other Study ID Numbers: 130175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No