Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000379415p
Ethics application status
Submitted, not yet approved
Date submitted
7/04/2025
Date registered
29/04/2025
Date last updated
29/04/2025
Date data sharing statement initially provided
29/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study to evaluate the impact of an intensive TheraPutty® hand exercise intervention
on strength and function in people with Inclusion Body Myositis (IBM)
Scientific title
A pilot study to evaluate the impact of an intensive TheraPutty® hand exercise intervention
on strength and function in people with Inclusion Body Myositis (IBM)
Secondary ID [1] 314157 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inclusion Body Myositis 336990 0
Condition category
Condition code
Neurological 333451 333451 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is a 12-week intensive hand exercise programme using TheraPutty®.
Participants will follow a physiotherapist-prescribed 12-week programme of 4 x hand exercises, to be completed on at least 3 days of the week. The hand exercises utilise TheraPutty®, with putty resistance matched to participant's strength. At the Baseline visit, the study physiotherapist will assess participants and allocate the appropriate resistance of putty. Participants are provided with education and information on the exercise programme via a video and handout. This video and accompanying handout has been created by the Myositis Discovery Programme team, a multi-disciplinary myositis research group, for use by IBM patients under their clinical care. The video and handout is intended for use within usual clinical care where appropriate, however is not publicly available.


The exercise programme consists of 4 x core exercises and up to 7 x bonus exercises, to be completed with each hand, on at least 3 days of the week. Exercises are focussed on the hand/forearm muscle groups impacted in IBM. Participants are provided with a daily diary to record their exercise and also are emailed a weekly diary to report on compliance and provide any feedback to the study team, as well as reporting any adverse events.
Participants will gradually increase the number of repetitions of the exercises as the programme progresses. In weeks 1&2, they will complete 10 repetitions of each exercise, in weeks 3&4, this will increase to 20 repetitions. In weeks 5&6, this again increases to 30 repetitions of each exercise. At the week 6 assessment, participant's strength is re-evaluated and if progress has been made, they will be allocated to the next level strength putty, and will resume exercises with the higher resistance putty for Week 7. During weeks 7&8, they will complete 10 repetitions of each exercise, during weeks 9&10 they will completed 20 repetitions and for weeks 11&12 they will complete 30 repetitions.
Intervention code [1] 330749 0
Rehabilitation
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341024 0
Change in hand grip strength, from Baseline to Week 12
Timepoint [1] 341024 0
Baseline, Week 6, Week 12 post-intervention commencement
Secondary outcome [1] 445857 0
Change in 2-point pinch grip strength from Baseline to Week 12 post-intervention commencement
Timepoint [1] 445857 0
Baseline, Week 6, Week 12 post-intervention commencement
Secondary outcome [2] 445858 0
Change in 3-point pinch grip from Baseline to Week 12 post-intervention commencement
Timepoint [2] 445858 0
Baseline, Week 6, Week 12 post-intervention commencement
Secondary outcome [3] 445859 0
Change in lateral pinch grip from Baseline to Week 12 post-intervention commencement
Timepoint [3] 445859 0
Baseline, Week 6, Week 12 post-intervention commencement
Secondary outcome [4] 445860 0
Change in function scores from Baseline to Week 12 post-intervention commencement
Timepoint [4] 445860 0
Baseline, Week 6, Week 12 post-intervention commencement
Secondary outcome [5] 445861 0
Change in finger dexterity/fine motor skill function from Baseline to Week 12
Timepoint [5] 445861 0
Baseline, Week 6, Week 12 post-intervention commencement
Secondary outcome [6] 445862 0
Change in gross manual dexterity/motor skills from Baseline to Week 12 post-intervention commencement
Timepoint [6] 445862 0
Baseline, Week 6, Week 12 post-intervention commencement
Secondary outcome [7] 445863 0
Change in hand function from Baseline to Week 12
Timepoint [7] 445863 0
Baseline, Week 6, Week 12 post-intervention commencement
Secondary outcome [8] 445864 0
To determine the acceptability and tolerability of the intervention (composite outcome)
Timepoint [8] 445864 0
Daily and weekly from Baseline to Week 12 post-intervention commencement
Secondary outcome [9] 445865 0
To determine the acceptability and tolerability of the overall programme (composite outcome)
Timepoint [9] 445865 0
Week 12 post-intervention commencement

Eligibility
Key inclusion criteria
• Aged 18 years or older;
• Able to read and understand the study information and intervention instructions, provided in
English;
• Able to provide informed consent for the study;
• Has a confirmed diagnosis of Inclusion Body Myositis by a neuromuscular specialist;
• Able to complete three study visits of approximately 1 hour duration over a 12 week period,
at Baseline, Week 6 (+ 14 days) and Week 12 (+/- 7 days)
• Manual Muscle Testing (MMT) score equal to or greater than Grade 3/5 in Flexor Digitorum Superficialis (FDS)
and Flexor Pollicus Longus (FPL) in at least one hand;
• Able to hold and manipulate TheraPutty® in at least one hand.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of injury, surgery or other condition that may cause pain or discomfort or prevent the
participant from performing strength testing or the intervention;
• Any condition precluding the participant from performing any part of the study procedures;
• Any assessment by the Sponsor-Investigator that the participant is unable or unsafe to take
part in the study;
• Allergy or sensitivity to any of the TheraPutty® ingredients (silicon polymer);
• Participation in any other clinical trial that could interfere with the outcome of this study;
• Actively undertaking structured hand exercise programme or has undertaken structured hand exercise programme in last 3 months.

Study design
Purpose of the study
Treatment
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
30/11/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27727 0
Perron Institute for Neurological and Translational Science - Nedlands
Recruitment postcode(s) [1] 43916 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318668 0
Other Collaborative groups
Name [1] 318668 0
Myositis Discovery Programme
Country [1] 318668 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
Country
Australia
Secondary sponsor category [1] 321089 0
None
Name [1] 321089 0
Address [1] 321089 0
Country [1] 321089 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317282 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 317282 0
Ethics committee country [1] 317282 0
Australia
Date submitted for ethics approval [1] 317282 0
26/02/2025
Approval date [1] 317282 0
Ethics approval number [1] 317282 0

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

Contacts
Principal investigator
Name 140554 0
Prof Merrilee Needham
Address 140554 0
Murdoch University / Perron Institute for Neurological and Translational Science, c/- Murdoch University, Personalised Medicine Centre, Building 390, Discovery Way, Murdoch WA 6150
Country 140554 0
Australia
Phone 140554 0
+61 8 93601365
Fax 140554 0
Email 140554 0
[email protected]
Contact person for public queries
Name 140555 0
Kelly Beer
Address 140555 0
Murdoch University / Perron Institute for Neurological and Translational Science, Murdoch University / Perron Institute for Neurological and Translational Science, c/- Murdoch University, Personalised Medicine Centre, Building 390, Discovery Way, Murdoch WA 6150
Country 140555 0
Australia
Phone 140555 0
+61 8 93601365
Fax 140555 0
Email 140555 0
[email protected]
Contact person for scientific queries
Name 140556 0
Kelly Beer
Address 140556 0
Murdoch University / Perron Institute for Neurological and Translational Science, Murdoch University / Perron Institute for Neurological and Translational Science, c/- Murdoch University, Personalised Medicine Centre, Building 390, Discovery Way, Murdoch WA 6150
Country 140556 0
Australia
Phone 140556 0
+61 8 93601365
Fax 140556 0
Email 140556 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]; [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.