Technology-based Analysis of Movement Disorders

NCT04591132 | Unknown

• 1 other identifier: 130175
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Movement Disorders

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• correlation with UPDRS gait Item

  up to 6 weeks after enrolment

Study Arms (1)

kinematic analysis

EXPERIMENTAL

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

Interventions

kinematic analysis DEVICE

motor tasks appropriate for each diagnosis will be recorder with wearable inertial sensors

kinematic analysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• to 80 years of age
• Willing and able to provide informed consent
• able to walk unassisted

You may not qualify if:

• Change in pharmacological therapy in the last 3 months.
• Orthopaedical comorbidities affecting gait or posture.
• Cognitive deficit

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

kailash P Bhatia

CONTACT

020 3448 4229; k.bhatia@ucl.ac.uk

giulia di lazzaro

CONTACT

02034484229; giulia.dilazzaro@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: October 19, 2020
• Study Start: November 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share