Kinematic Assessment In Multiple Sclerosis

NCT ID: NCT04283071

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-07
• Study Completion Date: 2021-10-30

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Boxed infrared gross kinematic assessment tool

Intervention Type: 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

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

Boxed infrared gross kinematic assessment tool

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leeds

OTHER

Sponsor Role: collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linford Fernandes

Role: PRINCIPAL_INVESTIGATOR

Leeds Teaching Hospitals NHS Trust

Locations

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

NE19/126048

Identifier Type: -

Identifier Source: org_study_id