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Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.
Under and Over Rehabilitation Study
Study Purpose
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. The 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. This 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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 65 Years |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04490044 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Queen Mary University of London |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
Overall Status | Not yet recruiting |
Countries | United Kingdom |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Sclerosis |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Posting a Trial
If you would like us to post a study on these pages, please email studies@nmss.org to find out what information you need to submit for review.