Under and Over
Research type
Research Study
Full title
Under & Over: A controlled study to develop an upper limb rehabilitation tool for people with Multiple sclerosis.
IRAS ID
285101
Contact name
Gavin Giovannoni
Contact email
Sponsor organisation
Queen Mary University of London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Multiple Sclerosis (MS) is a progressive neurological condition of the central nervous system for which there is no cure. Symptoms include motor and sensory dysfunction, bladder and bowel dysfunction as well as speech and swallowing difficulties. It commonly leads to cumulative, mixed disabilities over time. The combination of different symptoms and disabilities often limits a person’s ability to perform activities of daily living and to actively participate in social and occupational activities which then impacts on their quality of life.\n \nThe two main strategies for managing MS symptoms include, medication and rehabilitation. However, historically treatment strategies have focused predominantly on preserving lower limb function thus strategies to improve upper limb function is often neglected. The importance of maintaining upper limb (hand and arm) function is significant for people who have already lost lower limb function. Further loss of functioning contributes to low mood, reduced independence and quality of life. \n \nThis study aims to research how an engaging everyday activity, Under & Over, can become a rehabilitation tool to improve upper limb function in people with MS. The study will use a randomised wait list control group design, meaning that participants will be randomised to either the immediate rehabilitation group or the wait list group. Each group will perform the Under & Over task for 12 weeks, following a predetermined programme of instructions. Participants will complete a number of baseline measures measuring their current upper limb function, their quality of life and level of fatigue. This will happen at the start of the study, after 12 weeks of rehabilitation activity and again at a 12 week follow up.\n\nParticipants will access study information through the study website. This will provide the consenting procedure, study information, record participants responses and support (anonymised) participant interaction. \n \n\n
Lay Summary of Results:
This study tested a new rehabilitation activity called Under & Over, designed to help people with advanced Multiple Sclerosis (MS) improve the function of their hands and arms. The activity involves threading shoelaces through a board to create patterns, encouraging repeated hand and arm movements that may support rehabilitation.
U&O STUDY REPORT_Final
A total of 106 people with MS took part in the study. Participants completed the activity at home over a three-month period and recorded their results online. Researchers measured changes in hand function, quality of life and fatigue using established clinical questionnaires and tests.
The results showed no significant improvement in hand function when measured using the standard dexterity test used in the study. However, some participants reported subjective improvements in how they felt and used their hands, and fatigue levels decreased across the study groups at six months.
The study also demonstrated that it is feasible to run a remote rehabilitation study with people with advanced MS, allowing participants to take part from home. This approach reduced the burden of travel but also highlighted challenges such as participant drop-out and maintaining engagement over time.
Overall, the findings suggest that while the tool itself did not produce measurable improvements using the chosen outcome measures, remote rehabilitation approaches are possible and acceptable for people with advanced MS. The study also highlights the importance of selecting outcome measures that are sensitive to change in this population
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: N/A
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F38447394%252F%2FNBTI%2FqtXDAQ%2FAQ%2Fe728bf9e-f994-4f0c-bd8c-658ceb54d6f8%2F1%2FdbYZvHlTLH&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7Cab523642f9a44ea7442208de7b76fced%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639083948177359344%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=NCd6shpGzAQRj6euQ%2FuX32qz4w6ZtOvLBe2X9W3BGhQ%3D&reserved=0
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: Accessible study information was shared with the participants online and through social media to wider audiences.
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: Through requests to research team
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: N/A
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Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
20/YH/0259
Date of REC Opinion
26 Oct 2020
REC opinion
Further Information Favourable Opinion