Technology-based Analysis of Movement Disorders

Movement Disorders Clinical Trial

Official title:

Technology-based Analysis of Movement Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04591132
• Other study ID #: 130175
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: October 1, 2023

Study information

• Verified date: October 2020
• Source: University College, London
• Contact: kailash P Bhatia
• Phone: 020 3448 4229
• Email: k.bhatia[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Movement Disorders

Intervention

Device:
• kinematic analysis
motor tasks appropriate for each diagnosis will be recorder with wearable inertial sensors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	tremor peak frequence	fourier analysis for peak frequence of tremor	up to 6 weeks after enrolment
Primary	neck ROM	range of motion of the neck in x,y and z axis	up to 6 weeks after enrolment
Primary	bradykinesia evaluation	amplitude of repeated limb movements over time	up to 6 weeks after enrolment
Secondary	correlation with UPDRS gait Item	correlation of gait metrics with UPDRS gait score included.	up to 6 weeks after enrolment