Rehabilitation enhancing support for therapeutic orthosis and rehabilitation efforts

Plain English summary of protocol

Background and study aims
The study is exploring the use of a new wrist-hand device to support hand and wrist function. We are interested in understanding how the device affects movement, comfort and the ability to carry out every day tasks, as well as gathering your feedback to help improve the design.

Who can participate?
You can participate if you are between 18 and 79 years old, are a registrant of the SHARE database and if you meet the criteria needed for our study and are part of the people in the community who have been prescribed a wrist hand orthosis, with or without a thumb brace to reduce pain and/or help with their activities of daily living.

What does the study involve?
If you decide to take part, you would be asked to attend two laboratory sessions, each lasting approximately 3.5 hours, and a group discussion (focus group).
Test Session Day 1: During your first visit, you will be asked to complete a series of hand movements and strength tests under three conditions:
1. Without wearing a Wrist-hand orthosis/device/brace
2. Wearing your current device
3. Wearing a new study device
We will ask about your comfort, any pain or discomfort, and how easy or difficult you find the tasks.
Test Session Day 2: During your second visit, you will complete everyday tasks (such as writing or simple food-related tasks), again under the same three conditions.
Focus Groups: You will also be invited to take part in a group discussion to share your experiences using the device. As part of the study, we may also capture images of your hand during tasks to help us understand movement. This is optional, and you can still take part if you prefer not to have images taken. The device being tested is new and has not yet been approved for clinical use. Some participants may experience mild discomfort, irritation or temporary changes in how they move while getting used to the device. You are free to stop taking part at any time. Participants will receive payment for taking part in each stage of the study, and reasonable travel costs (such as public transport or taxi fares) will be reimbursed.

What are the possible benefits and risks of participating?
We do not expect that taking part will benefit you directly. However, your involvement will help us better understand how this type of device may affect people with wrist or hand conditions or injuries, and this could help improve care for others in the future. We have designed this study to be as safe as possible, but there are some potential risks to be aware of:
Skin irritation (low risk). Wearing the device may cause redness, pressure marks or irritation, especially if you have sensitive skin. We will show you how to fit it properly and will check in with you during the study. Any skin problems will be recorded and monitored as part of the study’s safety procedures. If symptoms persist or worsen, we will advise you to seek appropriate medical care (e.g., your GP).
Increased pain or discomfort (low to moderate risk)
The device may feel uncomfortable at first, and you notice increased pain or stiffness when using it. We will guide you on how to use it safely. You should stop using it if the pain becomes worse. Unknown effects on recovery (low risk). As this is a new device, we do not fully know how it may affect your recovery. In some cases, it could slow recovery or place too much strain on the wrist (for example, if the wrist is overstretched). We will provide guidance on safe use and monitor you during the study sessions. You can always stop the study if your symptoms worsen.
Adjusting to a new way of moving (muscle memory) (low to moderate risk). Your body may be used to moving your wrist and hand in a certain way. Using the device may change how you move, which can feel unfamiliar at first. This may lead to mild discomfort, awkward movements, or temporary difficulty completing tasks. Most people adjust over time. We will support you during testing, and you can stop at any time if you feel uncomfortable.
The device may not suit you (low risk). We may find that the device does not work well for your specific condition or needs. If this happens, we will address any concerns and may ask you to stop taking part.
Frustration or tiredness (moderate risk)
The device may not meet your expectations, and some of the testing tasks may feel tiring or frustrating. We will explain what to expect and support you throughout the study. Device problems (low risk)
As this is a new device, it may occasionally break or not work as expected. If this happens, we will deal with it promptly and during the study session. Unexpected health findings (low risk). During testing, we may notice issues such as movement difficulties or weakness that you were not aware of. If this happens, we will discuss it with you sensitively and may suggest that you speak to your GP.

Where is the study run from?
The study is run from Tayside Orthopaedic and Rehabilitation Technology (TORT) Centre in Ninewells Hospital, Dundee (UK)

When is the study starting and how long is it expected to run for?
June 2026 to December 2027

Who is funding the study?
Tay Health Tech, a Place-Based Impact Acceleration Account funded by the Engineering and Physical Sciences Research Council (EPSRC) (UK)

Who is the main contact?
For any questions or additional information about the study, please contact the research team, Dr Martin Seyres, Dr Alejandra Aranceta-Garza or Karyn Ross, by one of the following methods: Telephone: 01382 381634 (Monday – Friday, 9am – 5pm)
Email: mseyres001@dundee.ac.uk / aarancetagarza001@dundee.ac.uk / k.ross@strath.ac.uk
You can also contact the Chief/Principal investigator, Prof. Arpit Jariwala: Email: ajariwala@dundee.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• Scotland

Study participating centre

Results and Publications

Editorial Notes

29/06/2026: Study's existence confirmed by West of Scotland REC 4.