None listed
Conditions
Brief 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.
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 in
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.
Sponsors
Murdoch University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed