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Kinematic Assessment In Multiple Sclerosis

The Evaluation of Upper Limb Function in Multiple Sclerosis Using Kinematic Assessment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04283071
Acronym
KAIMS
Enrollment
57
Registered
2020-02-25
Start date
2019-11-07
Completion date
2021-10-30
Last updated
2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Upper limb function, Kinematic assessment

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

Interventions

DEVICEBoxed infrared gross kinematic assessment tool

An optical motion capture system, which records the movements of infrared emitting diodes (IREDs) in three-dimensional (3D) space by triangulating images from a pair of infrared cameras

Sponsors

University of Leeds
CollaboratorOTHER
The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in upper limb kinematic function in patients with progressive multiple sclerosis12 monthsKinematic function will be measured using the Boxed Infrared Kinematic Assessment Tool

Secondary

MeasureTime frameDescription
Change in 9-hole PEG test performance in patients with progressive multiple sclerosis12 monthsThe 9HPT is a brief, standardized, quantitative test of upper extremity function. Two consecutive trials with the dominant hand are immediately followed by two consecutive trials with the non-dominant hand. The two trials for each hand are averaged.
Change in EDSS in patients with progressive multiple sclerosis12 monthsThe Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time.
Change in patient reported outcome measures in patients with progressive multiple sclerosis12 monthsThe ABILHAND and AMSQ-SF questionnaires will be administered to participants in the trial

Other

MeasureTime frameDescription
Association between upper limb kinematic function and 9-hole PEG test and EDSS in progressive multiple sclerosis12 monthsThe kinematic measures used in this study will be compared to the use of current standard measures of testing function in multiple sclerosis, like the 9 hole PEG test and the EDSS

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026