Movement DisordersNCT04591132
Technology-based Analysis of Movement Disorders
A study testing kinematic analysis in people with Movement Disorders, run by University College, London.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Movement Disorders
- What is being tested?
- kinematic analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- Choereic syndrome
- Essential tremor
- Dystonic tremor
- 18 to 80 years of age
- Willing and able to provide informed consent
- able to walk unassisted
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- kinematic analysis
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinematic analysisDevice
motor tasks appropriate for each diagnosis will be recorder with wearable inertial sensors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: kinematic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 weeks after enrolment
tremor peak frequence
fourier analysis for peak frequence of tremor
Measured: up to 6 weeks after enrolment
neck ROM
range of motion of the neck in x,y and z axis
Measured: up to 6 weeks after enrolment
bradykinesia evaluation
amplitude of repeated limb movements over time
Measured: up to 6 weeks after enrolment
Secondary outcomes (1)
correlation with UPDRS gait Item
correlation of gait metrics with UPDRS gait score included.
Measured: up to 6 weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591132
- Sponsor's protocol ID
- 130175
- Status last verified
- Oct 2020
- First submitted
- 29 May 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-based Analysis of Movement Disorders
- ClinicalTrials.gov ID
- NCT04591132
- Acronym / sponsor ID
- 130175
- Conditions
- Movement Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kinematic analysis | Experimental | Device: kinematic analysiseach 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- clinical diagnosis of parkinsonism and/or dystonia and/or tremor due to:
- 18 to 80 years of age
- Willing and able to provide informed consent
- able to walk unassisted
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kinematic analysismotor tasks appropriate for each diagnosis will be recorder with wearable inertial sensors | Device | kinematic analysis |
Primary outcome
gait metrics
Time frame: 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.
tremor peak frequence
Time frame: up to 6 weeks after enrolment
fourier analysis for peak frequence of tremor
neck ROM
Time frame: up to 6 weeks after enrolment
range of motion of the neck in x,y and z axis
bradykinesia evaluation
Time frame: up to 6 weeks after enrolment
amplitude of repeated limb movements over time
1 secondary outcome
correlation with UPDRS gait Item
Time frame: up to 6 weeks after enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing kinematic analysis in people with Movement Disorders, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kailash P Bhatia (020 3448 4229, k.bhatia@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait metrics (time frame: up to 6 weeks after enrolment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.