Multiple Sclerosis Clinical Trial
— KAIMSOfficial title:
The Evaluation of Upper Limb Function in Multiple Sclerosis Using Kinematic Assessment
Verified date | February 2022 |
Source | The Leeds Teaching Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 57 |
Est. completion date | October 30, 2021 |
Est. primary completion date | October 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Leeds Teaching Hospitals NHS Trust | Leeds |
Lead Sponsor | Collaborator |
---|---|
The Leeds Teaching Hospitals NHS Trust | University of Leeds |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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