Kinematic Assessment In Multiple Sclerosis (KAIMS)

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

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Boxed infrared gross kinematic assessment tool

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary or secondary progressive multiple sclerosis who report an impairement in their hand function

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient; Progressive MS patients administered clinical examination measures including EDSS, nine-hole PEG test, patient reported outcomes measures and kinematic assessment of upper limb function	Device: Boxed 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
Control; Healthy volunteers administered nine-hole PEG test and kinematic assessment of upper limb function	Device: Boxed 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in upper limb kinematic function in patients with progressive multiple sclerosis	Kinematic function will be measured using the Boxed Infrared Kinematic Assessment Tool	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 9-hole PEG test performance in patients with progressive multiple sclerosis	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.	12 months
Change in EDSS in patients with progressive multiple sclerosis	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.	12 months
Change in patient reported outcome measures in patients with progressive multiple sclerosis	The ABILHAND and AMSQ-SF questionnaires will be administered to participants in the trial	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between upper limb kinematic function and 9-hole PEG test and EDSS in progressive multiple sclerosis	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	12 months

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust
• Collaborators: University of Leeds
• Investigators: Principal Investigator: Linford Fernandes, Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 7, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Upper limb function; Kinematic assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: NE19/126048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No