Clincosm LogoSign in Get a demo

Technology-based Analysis of Movement Disorders

Sponsor
University College, London (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04591132
Collaborator
(none)
50
Enrollment
1
Arm
35
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: kinematic analysis
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Technology-based Analysis of Movement Disorders
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. gait metrics [up to 6 weeks after enrolment]

    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.

  2. tremor peak frequence [up to 6 weeks after enrolment]

    fourier analysis for peak frequence of tremor

  3. neck ROM [up to 6 weeks after enrolment]

    range of motion of the neck in x,y and z axis

  4. bradykinesia evaluation [up to 6 weeks after enrolment]

    amplitude of repeated limb movements over time

Secondary Outcome Measures

  1. correlation with UPDRS gait Item [up to 6 weeks after enrolment]

    correlation of gait metrics with UPDRS gait score included.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University College, London

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University College, London
ClinicalTrials.gov Identifier:
NCT04591132
Other Study ID Numbers:
  • 130175
First Posted:
Oct 19, 2020
Last Update Posted:
Oct 19, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Movement Disorders

Study Results

No Results Posted as of Oct 19, 2020