Skip to main content
OpenTrials
Completed

NCT Number: NCT04283071

Kinematic Assessment In Multiple Sclerosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Boxed infrared gross kinematic assessment tool

Device

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

Primary outcomes

  1. Change in upper limb kinematic function in patients with progressive multiple sclerosis

    Time frame: 12 months

    Kinematic function will be measured using the Boxed Infrared Kinematic Assessment Tool

Secondary outcomes

  1. Change in 9-hole PEG test performance in patients with progressive multiple sclerosis

    Time frame: 12 months

    The 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.

  2. Change in EDSS in patients with progressive multiple sclerosis

    Time frame: 12 months

    The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time.

  3. Change in patient reported outcome measures in patients with progressive multiple sclerosis

    Time frame: 12 months

    The ABILHAND and AMSQ-SF questionnaires will be administered to participants in the trial

Other outcomes

  1. Association between upper limb kinematic function and 9-hole PEG test and EDSS in progressive multiple sclerosis

    Time frame: 12 months

    The 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

Sponsors and collaborators

Lead sponsor

The Leeds Teaching Hospitals NHS Trust

Other

Collaborators

  • University of Leeds

Registry information

Official study title

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

Acronym: KAIMS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 25, 2020
Registry last updated
Mar 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.