Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04490044 |
| Other study ID # |
285101 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2020 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
July 2020 |
| Source |
Queen Mary University of London |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
Description:
MS is a chronic progressive disease of the central nervous system and is the leading cause of
non-traumatic disability in young and middle aged adults. It commonly leads to cumulative,
mixed disabilities over time, ranging from motor and sensory impairments to fatigue, impaired
vision, cognitive deficits, speech and swallowing problems, bladder, bowel and sexual
dysfunction. 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.
Historically, MS treatments have predominantly focused on preserving lower limb function -
the ability to walk - and this is reflected in the main areas of clinical practice and
research.
Firstly, within the current treatment options, none are licensed for people with advanced
forms of MS. Secondly, wheelchair users are excluded from the majority of clinical trials as
it is thought to be difficult to measure clinical change in people whose motor functions are
already severely affected. Finally, and related to the second point, the gold standard of
disease measurement, the expanded disability status scale (EDSS) is weighted towards mobility
i.e. a person's ability to walk. Results of a recent study (ASCEND, NCT01416181) highlighted
these problems as the primary outcome of the trial was negative; the EDSS and 25-foot timed
foot walk, measures of lower limb function dominated the composite measure. However, the nine
hole peg test (9HPT), a measure of upper limb function, was positive; trial participants who
received natalizumab showed no loss of upper limb function, confirmed at 12 weeks, compared
to participants with secondary progressive MS who received placebo.
The Barts MS Research team based at QMUL feel that there now needs to be a shift in focus to
reposition the importance of upper limb functions for people with MS.
In August 2016 the investigators launched the #ThinkHand campaign to raise awareness and also
initiate discussions amongst patients, clinicians, charities, pharmaceutical companies,
regulators and the general public to realise the importance and work towards generating
evidence to develop treatments for advanced MS. As part of this campaign, our team has
conducted a number of PPI activities at academic conferences, online and at patient events
around this topic. Part of this included an online survey where 88% of people with MS (314 of
360 respondents) described their upper limb function to be more important to them than their
lower limb function (Dubuisson, Baker, et al., 2017).
This highlights the importance of upper limb function from the patient perspective and the
unique experiential knowledge of living with the condition that people with MS have. This is
supported by clinical studies; Bertoni et al. (2015) provide evidence that 75% of people with
MS have bilateral impaired manual dexterity even in the early stages of the disease. Arm and
hand function, are very important to perform activities of daily living like eating, dressing
and grooming (Yozbatiran et al., 2006), and even more so for people who have already lost
lower limb function as further loss of functioning contributes to low mood, reduced
independence and quality of life. Therefore, it is imperative that treatments are aimed at
preserving upper limb function.
Tools to maintain upper limb function for people with multiple sclerosis
Current rehabilitation tools and activities focus on measures of body functions and
structures looking at the capacity to assess the maximal ability to complete a task or an
action (e.g. the 9HPT is gold standard objective measure for manual dexterity (Fischer et
al., 1999)) or an activity performance measure measuring the person's habitual performance of
tasks in their normal environment (the ABILHAND).
There are a range of upper limb rehabilitation tools in use, but few have been used in MS
research and the investigators are aware of only one developed specifically for people with
MS (Lamers et al., 2016). For example the ABILHAND was originally developed for rheumatoid
arthritis with subsequent versions developed for people with stroke (Penta et al., 1998).
Although these have been validated for use with people with MS (Barrett et al., 2013) their
transference from one condition to another poses problems in that the activities that are
included lack relevance to the activities specific to living with MS. They also lack
relevance to modern living. For example, they are influenced by the ability to walk and there
is no mention of urinary catheters, and no mention of new technologies such as the use of
touchscreen phones or tablets in the ABILHAND.
Developing a new rehabilitation tool for upper limb function in MS
This study will develop a new upper limb rehabilitation tool to specifically improve upper
limb function in people with MS using a more participatory approach to tool development. This
is inspired by participatory research as the study has been designed by people with MS and
will involve people with MS with upper limb problems, who are the people whose activities are
under study.
Outcome measures and rehabilitation activities are typically derived by clinicians and
University researchers who only involve patients at specific stages. They therefore embed
what these medical and academic professionals believe to be a "good" outcome, i.e. one that
is clinically meaningful from the perspective of the clinician and the researcher but these
outcomes may not be meaningful to the patients themselves. Further, Lamers and Feys (2014)
state that a key characteristic of outcome measures that has been overlooked in MS is how
they can be used to facilitate the evolution of rehabilitation content and strategies. This
highlights the need to develop tools that include activities that are meaningful to
individual patients and can enable them to develop strategies and continue to do these
activities.
