Clinical trial NCT04283071: Kinematic Assessment In Multiple Sclerosis
Official title: The Evaluation of Upper Limb Function in Multiple Sclerosis Using Kinematic Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Upper limb function
Kinematic assessment
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University of Leeds
First posted: 2020-02-25
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary or secondary progressive multiple sclerosis who report an impairement in their hand function

Brief summary: Multiple sclerosis (MS) affects more than a 120,000 people in the United Kingdom and is the commonest neurological condition in young adults. MS causes a number of symptoms including weakness, altered sensation, pain and memory difficulties. There are different forms of MS, including relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS). Currently there are several effective treatments for RRMS, but no NICE approved treatment for SPMS. Patients with PPMS and SPMS experience a gradual progression in disability that affects individual patients differently. A number of clinical scores are used to quantify the disability in individual patients and some of these scores focus on the patients' lower limb function. In the progressive forms of MS, preservation of upper limb function becomes a more important concern for patients to maintain their quality of life.

With the advent of new treatment trials for PPMS and SPMS, it is important that clinicians and researchers are able to use accurate and quantifiable measures of upper limb function to evaluate any changes with time or response to treatment. The use of motion tracking software provides a unique opportunity to accurately track movements in real time and space and give a tailored assessment of an individual's function.

The overall aim of this study is to use established kinematic assessment tools to explore the extent and progression of upper limb dysfunction in patients with progressive MS. This aim will be achieved via the following objectives:

* Recruit a sample of participants with PPMS and SPMS from the local MS population
* Quantify the physical impairment in these participants using existing clinical scores as well the kinematic assessment tools that have been developed
* Follow-up the participants for a period of 12 months to identify and quantify any progression in their upper limb dysfunction
* Identify any factors that may influence upper limb dysfunction in this group
* Develop and evaluate the role of further kinematic techniques in this group of participants


Eligibility criteria: Inclusion Criteria:

* Age above 18 years at the time of enrolment into the study
* Participants with a confirmed diagnosis of MS that have entered the primary or secondary progressive stage for at least 12 months
* Participants must be able to comply with the terms and methods of the protocol
* Study specific written informed consent has been obtained

Exclusion Criteria:

* Age below 18 years at the time of enrolment into the study
* Participants with a diagnosis of RRMS
* Participants unable to comply with the terms or methods of the protocol
* Participants who report any cognitive or memory impairment
* Participants with significant co-morbidities that affect their upper limb function i.e. stroke etc.

Primary outcomes:
measure: Change in upper limb kinematic function in patients with progressive multiple sclerosis
timeFrame: 12 months
Secondary outcomes:
measure: Change in 9-hole PEG test performance in patients with progressive multiple sclerosis
timeFrame: 12 months
measure: Change in EDSS in patients with progressive multiple sclerosis
timeFrame: 12 months
measure: Change in patient reported outcome measures in patients with progressive multiple sclerosis
timeFrame: 12 months
Other outcomes:
measure: Association between upper limb kinematic function and 9-hole PEG test and EDSS in progressive multiple sclerosis
timeFrame: 12 months
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
affiliation: Leeds Teaching Hospitals NHS Trust
name: Linford Fernandes
role: PRINCIPAL_INVESTIGATOR
References: