Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04283071
Other study ID # NE19/126048
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 7, 2019
Est. completion date October 30, 2021

Study information

Verified date February 2022
Source The Leeds Teaching Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds

Sponsors (2)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05528666 - Risk Perception in Multiple Sclerosis
Completed NCT03608527 - Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis N/A
Recruiting NCT05532943 - Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis Phase 1/Phase 2
Completed NCT02486640 - Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
Completed NCT01324232 - Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis Phase 2
Completed NCT04546698 - 5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
Active, not recruiting NCT04380220 - Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
Completed NCT02835677 - Integrating Caregiver Support Into MS Care N/A
Completed NCT03686826 - Feasibility and Reliability of Multimodal Evoked Potentials
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Withdrawn NCT06021561 - Orofacial Pain in Multiple Sclerosis
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Recruiting NCT04798651 - Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis N/A
Active, not recruiting NCT05054140 - Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis Phase 2
Completed NCT05447143 - Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis N/A
Recruiting NCT06195644 - Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients Phase 1
Completed NCT04147052 - iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis N/A
Completed NCT03594357 - Cognitive Functions in Patients With Multiple Sclerosis
Completed NCT03591809 - Combined Exercise Training in Patients With Multiple Sclerosis N/A
Completed NCT03269175 - BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies Phase 4