RecruitingACTRN12625000379415

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)

Sponsor

Murdoch University

Enrollment

30 participants

Start Date

Jun 4, 2025

Study Type

Interventional

Conditions

Inclusion Body Myositis

Summary

Inclusion Body Myositis (IBM) is a rare, inflammatory myopathy characterised by progressive weakness primarily in the quadriceps and deep finger flexor muscles. There are currently no disease modifying drugs available to treat IBM. Current therapy is centred around symptomatic management, with exercise a mainstay of the treatment approach. However, information and evidence related to hand exercise is minimal, despite hand grip and finger strength being impacted significantly. This study aims to determine the effectiveness of a 12-week intensive ‘at-home’ hand therapy program using TheraPutty® on hand strength and function for people with IBM. This is a single arm study, with all enrolled participants undertaking the same 12-week hand exercise program. The study will evaluate the impact on strength and function as well as the tolerability and acceptability of the intervention for participants.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Inclusion Body Myositis (IBM) is a rare muscle disease that causes progressive weakness — particularly in the thighs and the muscles that bend the fingers. There are currently no medications that can slow or stop the disease. While exercise is an important part of management, there is very little research on hand-specific exercises for people with IBM, despite grip strength and finger function being significantly affected. This 12-week study will ask participants to do a structured hand therapy program at home using TheraPutty — a silicone-based resistance putty used in occupational therapy. Participants will be shown how to perform the exercises by an occupational therapist and will attend three assessment visits over 12 weeks to measure changes in hand strength and function. You may be eligible if you are 18 or older, have a confirmed diagnosis of IBM from a neuromuscular specialist, have enough finger strength to hold and work with TheraPutty in at least one hand, and can attend three visits at Murdoch University. People who are currently doing a structured hand exercise program, have recently had hand surgery, or have a silicone allergy are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.