Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001283561
Ethics application status
Approved
Date submitted
23/08/2024
Date registered
22/10/2024
Date last updated
22/10/2024
Date data sharing statement initially provided
22/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional Neurological Disorder (FND)- Informed Physiotherapy for organic tremor disorder - A Feasibility Study
Scientific title
FND-informed physiotherapy for organic tremor disorders in adults – A feasibility study
Secondary ID [1] 312749 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Neurologic disorder 334871 0
Condition category
Condition code
Neurological 331424 331424 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 2: Intervention phase: Patients will undergo a standardised 5-week program of weekly targeted physiotherapy sessions. The FND- informed will involve breathing exercises, grounding and distraction techniques.
The Physiotherapy sessions will be 30min each in duration and will focus on the following areas: 1) Education about principles of brain retraining, 2) Breathing and grounding techniques, 3) Distraction techniques, 4) Overriding abnormal movements, 5) Summary and development of patient-specific management advice.
Patients will be provided with written management advice for tremor flares. Patients will also be provided with exercise diaries by the study coordinator to monitor adherence.

Phase 3: 'Washout' and Reassessment phase: Patients will again undergo a formal tremor assessment in clinic with the use of the 3D accelerometer devices. After that patients will again wear these 3D accelerometers at home for 1 week while performing their everyday activities. During this phase patients will also be asked to keep a written diary for tremor flares and activities related to them.
The diary will be provided to the participants by the study coordinator.
Intervention code [1] 329343 0
Treatment: Other
Comparator / control treatment
In this study the participants themselves act as a comparator. The Phase 1 Of this study will act as the comparator arm of the study. In Phase 1 patients will initially undergo an initial tremor assessment in clinic with the use of two 3D accelerometer systems. One of the devices Blue Trident IMU, specifically measures tremor severity and frequency and the other device GENEActiv wristwatch monitors general activities (wake: standing, sitting, walking; sleep: duration, quality). After the initial assessment patients will wear the two 3D accelerometer systems at home for one week while performing their everyday activities. During this phase patients will also be asked to keep a written diary for tremor flares and activities related to them. The diary will be provided to the participants by the study coordinator.
Control group
Active

Outcomes
Primary outcome [1] 339180 0
Quality of life
Timepoint [1] 339180 0
At the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [1] 438956 0
Identification of variability of tremor severity in relation to daily activities through objective measures with IMU device.
Timepoint [1] 438956 0
At the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [2] 438957 0
Comparison of objective tremor data from IMU and GENEactive before and after intervention.
Timepoint [2] 438957 0
At the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [3] 438958 0
Overall changes to participant’s status on the Clinical Global Impressions-Improvement scale (CGI- I).
Timepoint [3] 438958 0
At the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [4] 438959 0
Correlation of tremor severity according to the Tremor Research Group Essential Tremor Rating Scale (TETRAS) at baseline compared to phase 3 assessment.
Timepoint [4] 438959 0
Baseline and at the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [5] 438960 0
General quality of life
Timepoint [5] 438960 0
Baseline and at the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [6] 438961 0
Emotional well being
Timepoint [6] 438961 0
Baseline and at the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [7] 438962 0
Changes of tremor frequency during home assessment and determination of which activities flares of tremors are associated with as derived from IMU device data
Timepoint [7] 438962 0
At the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [8] 439632 0
Identification of variability of tremor severity in relation to daily activities through objective measures with GENEactive devices.
Timepoint [8] 439632 0
At the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [9] 439633 0
Changes of tremor severity during home assessment and determination of which activities flares of tremors are associated with as derived from GENEactive device data
Timepoint [9] 439633 0
At the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [10] 440226 0
Changes of tremor frequency during home assessment and determination of which activities flares of tremors are associated with as derived from GENEactive device data
Timepoint [10] 440226 0
At the end of phase 3 after a 'washout' period of 5 weeks
Secondary outcome [11] 440227 0
Changes of tremor frequency and severity during home assessment and determination of which activities flares of tremors are associated with as derived from IMU device data
Timepoint [11] 440227 0
At the end of phase 3 after a 'washout' period of 5 weeks

Eligibility
Key inclusion criteria
1. Adults over the age of 18 years old and over.
2. Have received diagnosis of an organic tremor disorder affecting one or both upper limbs.
3. Able to read and write English.
4. Access to an Apple IOS device (iPhone or iPad
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
19/02/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26976 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 43051 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 317180 0
Government body
Name [1] 317180 0
SERTA Grant- Metro South Health
Country [1] 317180 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Country
Australia
Secondary sponsor category [1] 319448 0
None
Name [1] 319448 0
Address [1] 319448 0
Country [1] 319448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315924 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 315924 0
Ethics committee country [1] 315924 0
Australia
Date submitted for ethics approval [1] 315924 0
31/01/2024
Approval date [1] 315924 0
02/02/2024
Ethics approval number [1] 315924 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136234 0
Dr Alexander Lehn
Address 136234 0
Princess Alexandra Hospital,199 Ipswich Road, Woolloongabba, QLD 4102
Country 136234 0
Australia
Phone 136234 0
+61 0731764246
Fax 136234 0
Email 136234 0
[email protected]
Contact person for public queries
Name 136235 0
Schible Treasa Kurian
Address 136235 0
Princess Alexandra Hospital,199 Ipswich Road, Woolloongabba, QLD 4102
Country 136235 0
Australia
Phone 136235 0
+61 0436447386
Fax 136235 0
Email 136235 0
[email protected]
Contact person for scientific queries
Name 136236 0
Professor Graham Kerr
Address 136236 0
Queensland University of Technology | Kelvin Grove, Brisbane, QLD 4059,
Country 136236 0
Australia
Phone 136236 0
+61 0731386303
Fax 136236 0
Email 136236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.