Multiple SclerosisKAIMSNCT04283071
Kinematic Assessment In Multiple Sclerosis
An observational study of Multiple Sclerosis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Boxed infrared gross kinematic assessment tool
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Nov 2019to 30 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary or secondary progressive multiple sclerosis who report an impairement in their hand function
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Boxed infrared gross kinematic assessment tool
- Keywords
- Upper limb function, Kinematic assessment
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boxed infrared gross kinematic assessment toolDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Boxed infrared gross kinematic assessment tool | |
| Control | Healthy volunteers administered nine-hole PEG test and kinematic assessment of upper limb function Receives: Device: Boxed infrared gross kinematic assessment tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper limb kinematic function in patients with progressive multiple sclerosis
Kinematic function will be measured using the Boxed Infrared Kinematic Assessment Tool
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start7 Nov 2019
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Sponsor
- Investigators
- Linford Fernandes, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283071
- Sponsor's protocol ID
- NE19/126048
- Acronym
- KAIMS
- Status last verified
- Feb 2022
- First submitted
- 21 Feb 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Upper Limb Function in Multiple Sclerosis Using Kinematic Assessment
- ClinicalTrials.gov ID
- NCT04283071
- Acronym / sponsor ID
- KAIMS / NE19/126048
- Conditions
- Multiple Sclerosis
- Keywords
- Upper limb function, Kinematic assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Device: Boxed infrared gross kinematic assessment toolProgressive MS patients administered clinical examination measures including EDSS, nine-hole PEG test, patient reported outcomes measures and kinematic assessment of upper limb function |
| Control | – | Device: Boxed infrared gross kinematic assessment toolHealthy volunteers administered nine-hole PEG test and kinematic assessment of upper limb function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary or secondary progressive multiple sclerosis who report an impairement in their hand function
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boxed infrared gross kinematic assessment toolAn 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 | Device | Control, Patient |
Primary outcome
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
3 secondary outcomes
Change in 9-hole PEG test performance in patients with progressive multiple sclerosis
Time frame: 12 months
Change in EDSS in patients with progressive multiple sclerosis
Time frame: 12 months
Change in patient reported outcome measures in patients with progressive multiple sclerosis
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linford Fernandes principal investigator
Leeds Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in upper limb kinematic function in patients with progressive multiple sclerosis (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.