Multiple SclerosisMCS-III-ULNCT02339675
Psychometric Properties Upper Limb Function Measures Multiple Sclerosis
A study testing conventional MS rehabilitation in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
Trial summary
Current study will investigate de quality (psychometric properties) and clinical utility of several measures of upper limb function, according to disability level. Therefore, several aspects will be inquired: Was there an effect of rehabilitation Is the measure able to detect change over time? And thus the change… 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?
- conventional MS rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Jun 2016
- Phase
- Interventional
- 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
Who may be able to join
- diagnosis of MS according to McDonald criteria
- a treatment goal to maintain or improve upper limb function
- no relapse within the last month
- no changes in disease modifying medication and no corticoid-therapy within the last month
- receive at least 10 sessions of physical or occupational therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months
Who cannot join
- other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, …)
- other neurological impairments with permanent damage (stroke, Parkinson, …)
- MS-like syndromes such as neuromyelitis optica
- not able to understand and execute simple instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychometric Properties of Outcome Measures for Upper Limb Function, in Multiple Sclerosis: a Multi-center Study
Current study will investigate de quality (psychometric properties) and clinical utility of several measures of upper limb function, according to disability level. Therefore, several aspects will be inquired:
- Was there an effect of rehabilitation
- Is the measure able to detect change over time? And thus the change exceed measurement error and is it clinically important (responsiveness)
- Does the measure assess what it claims to measure (validity)
- Is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects)
- Does the measure gives similar results under consistent test conditions on another testing day (reliability) Worldwide, theoretical approaches to physical therapy and rehabilitation in Multiple Sclerosis often appear significantly different. Since the present research protocol will be performed at different centers across European countries (and US sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels.
Some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).
- Conditions
- Multiple Sclerosis
- Being tested
- conventional MS rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional MS rehabilitationOther
assessment pre and post conventional MS rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| convential MS rehabilitation | Other | Investigate the quality (psychometric properties) and clinical utility of several measures of the upper limb function Receives: Other: conventional MS rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pinch strength
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Nine Hole Peg Test (NHPT)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Box and Block Test (BBT)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Coin rotation task (CRT)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Spasticity 0-10 numeric rating scale (NRS/VAS)
Measured: day 1, end of study
Visual Analogue Scale muscle weakness
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale sensory
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale coordination
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale fatigability
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Manual Ability Measurement (MAM-36)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
ABILHAND scale
a measure of manual ability for adults with upper limb impairment
Measured: day 1, end of study
Performance Scale hand function (PS hand)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Upper Extremity Motor Activity Log (EU-MAL)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Secondary outcomes (5)
Hand grip strength (JAMAR)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Fatigability: plate tapping test
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Trunk Impairment Scale modified Norwegian version (TIS-modNV)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Action Research Arm test (ARAT) for patients with NHPT ≤0.27 peg/s (33.3 sec)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
International Physical Activity Questionnaire (IPAQ)
Measured: day 1 and at the end of the rehabilitation, an expected average of three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionJun 2016
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, Charles University, Czech Republic, Danish MS Hospitals, Haslev and Ry, Fondazione Don Carlo Gnocchi ETS, Italian Multiple Sclerosis Foundation, centrisclerosimultipla, Sheba Medical Center, Haukeland University Hospital, MS Rehabilitation Center Borne Sulinowo, University of Ljubljana, Eugenia Epalza Rehabilitation Center, Bilbao, Spain, Day General Hospital., Shepherd Center, Atlanta GA, Queen's University, St. Louis University, De Mick, MS center Hakadal AS
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Peter Feys, prof. dr., Principal investigator, Hasselt UniversityIlse Baert, dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339675
- Sponsor's protocol ID
- ML10456-S56575
- Acronym
- MCS-III-UL
- Status last verified
- May 2020
- First submitted
- 16 Dec 2014
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Properties of Outcome Measures for Upper Limb Function, in Multiple Sclerosis: a Multi-center Study
- ClinicalTrials.gov ID
- NCT02339675
- Acronym / sponsor ID
- MCS-III-UL / ML10456-S56575
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, Charles University, Czech Republic, Danish MS Hospitals, Haslev and Ry, Fondazione Don Carlo Gnocchi ETS, Italian Multiple Sclerosis Foundation, centrisclerosimultipla, Sheba Medical Center, Haukeland University Hospital, MS Rehabilitation Center Borne Sulinowo, University of Ljubljana, Eugenia Epalza Rehabilitation Center, Bilbao, Spain, Day General Hospital., Shepherd Center, Atlanta GA, Queen's University, St. Louis University, De Mick, MS center Hakadal AS
- Study start
- Oct 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Jan 2015 (estimated)
- 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.
Current study will investigate de quality (psychometric properties) and clinical utility of several measures of upper limb function, according to disability level. Therefore, several aspects will be inquired:
- Was there an effect of rehabilitation
- Is the measure able to detect change over time? And thus the change exceed measurement error and is it clinically important (responsiveness)
- Does the measure assess what it claims to measure (validity)
- Is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects)
- Does the measure gives similar results under consistent test conditions on another testing day (reliability) Worldwide, theoretical approaches to physical therapy and rehabilitation in Multiple Sclerosis often appear significantly different. Since the present research protocol will be performed at different centers across European countries (and US sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels.
Some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| convential MS rehabilitation | Other | Other: conventional MS rehabilitationInvestigate the quality (psychometric properties) and clinical utility of several measures of the upper limb function |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of MS according to McDonald criteria
- a treatment goal to maintain or improve upper limb function
- no relapse within the last month
- no changes in disease modifying medication and no corticoid-therapy within the last month
- receive at least 10 sessions of physical or occupational therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months
Key exclusion criteria (4 listed)
- other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, …)
- other neurological impairments with permanent damage (stroke, Parkinson, …)
- MS-like syndromes such as neuromyelitis optica
- not able to understand and execute simple instructions
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 |
|---|---|---|
| conventional MS rehabilitationassessment pre and post conventional MS rehabilitation | Other | convential MS rehabilitation |
Primary outcome
Pinch strength
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Nine Hole Peg Test (NHPT)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Box and Block Test (BBT)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Coin rotation task (CRT)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Spasticity 0-10 numeric rating scale (NRS/VAS)
Time frame: day 1, end of study
Visual Analogue Scale muscle weakness
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale sensory
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale coordination
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Visual Analogue Scale fatigability
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Manual Ability Measurement (MAM-36)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
ABILHAND scale
Time frame: day 1, end of study
a measure of manual ability for adults with upper limb impairment
Performance Scale hand function (PS hand)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Upper Extremity Motor Activity Log (EU-MAL)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
5 secondary outcomes
Hand grip strength (JAMAR)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Fatigability: plate tapping test
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Trunk Impairment Scale modified Norwegian version (TIS-modNV)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
Action Research Arm test (ARAT) for patients with NHPT ≤0.27 peg/s (33.3 sec)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three months
International Physical Activity Questionnaire (IPAQ)
Time frame: day 1 and at the end of the rehabilitation, an expected average of three 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 22 May 2020.
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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.
Peter Feys, prof. dr. principal investigator
Hasselt University
Ilse Baert, dr. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional MS rehabilitation in people with Multiple Sclerosis, run by Hasselt University at 1 site in Belgium.
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 5 inclusion and 4 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 22 May 2020. 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 Belgium. 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?
Pinch strength (time frame: day 1 and at the end of the rehabilitation, an expected average of three months). The study lists 13 primary outcomes in all. 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 22 May 2020.