Kinematic Assessment In Multiple Sclerosis

NCT04283071 | Completed

• 1 other identifier: NE19/126048
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Keywords

Upper limb function; Kinematic assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  12 months

• Change in EDSS in patients with progressive multiple sclerosis

  12 months

• Change in patient reported outcome measures in patients with progressive multiple sclerosis

  12 months

Other Outcomes (1)

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

  12 months

Study Arms (2)

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

Control

Healthy volunteers administered nine-hole PEG test and kinematic assessment of upper limb function

Device: Boxed infrared gross kinematic assessment tool

Interventions

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

Control; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead
• University of Leeds: collaborator

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Linford Fernandes

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: November 7, 2019
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)