Multiple SclerosisNCT04908891
A Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness
A study testing Clinical Scapular protocol (ClinScaP), the prevalence of trunk, scapula and upper limb impairments. and the interaction between trunk, scapula and upper limb impairments. in people with Multiple Sclerosis and Stroke, run by Hasselt University at 4 sites in Belgium.
Trial summary
The study aimed to provide insights in the coordination between trunk, shoulder and upper limb while reaching. Two main phases are present in this study: In phase A: the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS (Persons with Multiple Sclerosis) and healthy controls. 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Stroke
- What is being tested?
- Clinical Scapular protocol (ClinScaP), the prevalence of trunk, scapula and upper limb impairments. and the interaction between trunk, scapula and upper limb impairments.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesBelgium
- Study dates
- 12 Dec 2018to 30 Aug 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with MS (Multiple Sclerosis) using McDonald criteria
- Able to move at least 1 out of 3 joints (wrist, elbow or shoulder): Medical Research Council score 3.
- First- ever single, unilateral (ischemic or hemorrhagic) stroke
- No apraxia or hemi spatial neglect
- Able to move at least 1 out of 3 joints of the affected upper limb (wrist, elbow or shoulder): Medical Research Council score 3.
Who cannot join
- Other medical conditions interfering with the upper limb function or trunk (orthopedic or rheumatoid impairment)
- Perceived pain in one of the upper limbs of more than 4/10 (Visual Analog Scale)
- Severe cognitive or visual deficits interfering with testing
- For the PwMS: a relapse or relapse-related treatment in the last month prior to the study
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Ziekenhuis Oost-Limburg
Genk, 3600
Jessa Ziekenhuis- Campus St. Ursula
Herk-de-Stad, 3540
National MS Center Melsbroek
Melsbroek, 1820
Noorderhart MS & Revalidatie
Overpelt, 3900
About this study
The study aimed to provide insights in the coordination between trunk, shoulder and upper limb while reaching. Two main phases are present in this study:
In phase A: the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS (Persons with Multiple Sclerosis) and healthy controls.
- To investigate the test-retest reliability of the Clinical Scapular Protocol (ClinScaP) and the Reaching Performance Scale (RPS) in PwMS
- To investigate the discriminative of the ClinScaP between PwMS and healthy controls
- To investigate the discriminative of the RPS between PwMS and healthy controls
- To investigate the concurrent validity of ClinScaP and RPS in PwMS, compared with upper limb dysfunction measurements. In phase B:
- To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients.
- To investigate the interaction between trunk, scapula and upper limb impairments in PwMS and stroke patients.
- Conditions
- Multiple Sclerosis, Stroke
- Being tested
- Clinical Scapular protocol (ClinScaP), the prevalence of trunk, scapula and upper limb impairments., the interaction between trunk, scapula and upper limb impairments.
- Medical subject headings
- Multiple Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Scapular protocol (ClinScaP)Other
the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS and healthy controls.
the prevalence of trunk, scapula and upper limb impairments.Other
To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients.
the interaction between trunk, scapula and upper limb impairments.Other
To investigate the interaction between trunk, scapula and upper limb impairments in PwMS and stroke patients.
| Study group | Role | What they receive |
|---|---|---|
| persons with Multiple Sclerosis | Experimental | Not described Receives: Other: Clinical Scapular protocol (ClinScaP); Other: the prevalence of trunk, scapula and upper limb impairments.; Other: the interaction between trunk, scapula and upper limb impairments. |
| Healthy controls | Active comparator | Not described Receives: Other: Clinical Scapular protocol (ClinScaP) |
| Stroke Patients | Active comparator | Not described Receives: Other: the prevalence of trunk, scapula and upper limb impairments.; Other: the interaction between trunk, scapula and upper limb impairments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Reaching performance scale (RPS)
The Reaching performance scale (RPS) evaluates 6 components during reaching to a cup. The first four components:
- trunk displacement,
- movement smoothness,
- shoulder movements, and
- elbow movements. The components are evaluated during reaching movements to targets placed close or far from the person. The 2 additional components globally rate
- the quality of prehension and
- the accomplishment of the task.
Measured: baseline
The Reaching performance scale (RPS)
The Reaching performance scale (RPS) evaluates 6 components during reaching to a cup. The first four components:
- trunk displacement,
- movement smoothness,
- shoulder movements, and
- elbow movements. The components are evaluated during reaching movements to targets placed close or far from the person. The 2 additional components globally rate
- the quality of prehension and
- the accomplishment of the task.
Measured: Day 1
The clinical scapular protocol
The clinical scapular protocol consists of five items. A score is given between 0 and 2, based on observation of tilting and winging, shoulder girdle position (measuring acromial and pectoralis minor index and scapular distance test), scapular lateral rotation, maximal active humeral elevation, medial rotation test
Measured: Baseline
The clinical scapular protocol
The clinical scapular protocol consists of five items. A score is given between 0 and 2, based on observation of tilting and winging, shoulder girdle position (measuring acromial and pectoralis minor index and scapular distance test), scapular lateral rotation, maximal active humeral elevation, medial rotation test
Measured: day 1
Secondary outcomes (30)
Trunk Impairment Scale
Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.
Measured: Baseline
Trunk Impairment Scale
Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.
Measured: day 1
Box and Block test
This test assess gross manual dexterity by grasping each time one block and transporting the block to the other side over a wooden panel for one minute, while sitting.
Measured: Baseline
Box and Block test
This test assess gross manual dexterity by grasping each time one block and transporting the block to the other side over a wooden panel for one minute, while sitting.
Measured: day 1
The Brunnström Fugl Meyer (BFM)
The Brunnström Fugl Meyer (BFM) used to measure motor control at the body functions and structures level. The upper limb section is applied: shoulder, elbow, forearm, wrist movements and grip.
Measured: Baseline
The Brunnström Fugl Meyer (BFM)
The Brunnström Fugl Meyer (BFM) used to measure motor control at the body functions and structures level. The upper limb section is applied: shoulder, elbow, forearm, wrist movements and grip.
Measured: day 1
The Action Research Arm Test (ARAT)
Action Research arm test, which assessed the patient's ability to handle objects varying in size, weight and shape. The Action Research Arm Test (ARAT) assess the ability to manipulate objects in different size, weight and shape and finally results in a maximum score of 57
Measured: Baseline
The Action Research Arm Test (ARAT)
Action Research arm test, which assessed the patient's ability to handle objects varying in size, weight and shape. The Action Research Arm Test (ARAT) assess the ability to manipulate objects in different size, weight and shape and finally results in a maximum score of 57
Measured: day 1
The Nine Hole Peg Test (NHPT)
The Nine Hole Peg Test (NHPT) was used to assess manual dexterity by the time needed to place and remove nine pegs in a board.
Measured: baseline
The Nine Hole Peg Test (NHPT)
The Nine Hole Peg Test (NHPT) was used to assess manual dexterity by the time needed to place and remove nine pegs in a board.
Measured: day 1
The Manual Ability Measure-36 (MAM-36)
The Manual Ability Measure-36 (MAM-36) was used to assess perceived upper limb performance. The sum score is converted and resulted in a score between 0-100, with 100 as a perfect manual ability.
Measured: baseline
The Manual Ability Measure-36 (MAM-36)
The Manual Ability Measure-36 (MAM-36) was used to assess perceived upper limb performance. The sum score is converted and resulted in a score between 0-100, with 100 as a perfect manual ability.
Measured: day 1
Arm Function in Multiple Sclerosis Questionnaire
: A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis
Measured: Baseline
Arm Function in Multiple Sclerosis Questionnaire
: A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis
Measured: Day 1
Active and passive range of motion of shoulder, elbow and wrist movement
Active and passive range of motion of shoulder, elbow and wrist movement is measured with a goniometer Safety Issue?: Yes/No
Measured: Baseline
Active and passive range of motion of shoulder, elbow and wrist movement
Active and passive range of motion of shoulder, elbow and wrist movement is measured with a goniometer Safety Issue?: Yes/No
Measured: Day 1
Modified Ashworth Scale
Spasticity is evaluated with Modified Ashworth Scale
Measured: Baseline
Modified Ashworth Scale
Spasticity is evaluated with Modified Ashworth Scale
Measured: day 1
Maximal hand grip strength test (HGS)
HGS was assessed with the Jamar digital HGD (the hand grip dynamometer). Each participant performed three maximum contractions of each hand on three handle positions progressing from first to third position.
Measured: Baseline
Maximal hand grip strength HGS)
HGS was assessed with the Jamar digital HGD (the hand grip dynamometer). Each participant performed three maximum contractions of each hand on three handle positions progressing from first to third position.
Measured: Day 1
Symbol digit modalities test
Information of processing speed with the Symbol digit modalities test
Measured: Baseline
Symbol digit modalities test
Information of processing speed with the Symbol digit modalities test
Measured: Day 1
Modified fatigue impact scale
: Fatigue is evaluated a questionnaire: the modified fatigue impact scale
Measured: Baseline
Modified fatigue impact scale
: Fatigue is evaluated a questionnaire: the modified fatigue impact scale
Measured: Day 1
National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.[1] The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0
Measured: Baseline
National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.[1] The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0
Measured: Day 1
10 Meter loop test (10MWT)
The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)
Measured: baseline
10 Meter loop test (10MWT)
The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)
Measured: Day 1
Modified Rankin Scale (MRS)
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke
Measured: Baseline
Modified Rankin Scale (MRS)
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start12 Dec 2018
- Primary completion30 Aug 2021
- Study completion30 Aug 2022
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg, National MS Center Melsbroek, Jessa Hospital
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
- Investigators
- Ilse Lamers, dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908891
- Sponsor's protocol ID
- Neuro-JR-001
- Status last verified
- Jul 2024
- First submitted
- 26 May 2021
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness
- ClinicalTrials.gov ID
- NCT04908891
- Acronym / sponsor ID
- Neuro-JR-001
- Conditions
- Multiple Sclerosis, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg, National MS Center Melsbroek, Jessa Hospital
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 1 Jun 2021 (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.
The study aimed to provide insights in the coordination between trunk, shoulder and upper limb while reaching. Two main phases are present in this study:
In phase A: the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS (Persons with Multiple Sclerosis) and healthy controls.
- To investigate the test-retest reliability of the Clinical Scapular Protocol (ClinScaP) and the Reaching Performance Scale (RPS) in PwMS
- To investigate the discriminative of the ClinScaP between PwMS and healthy controls
- To investigate the discriminative of the RPS between PwMS and healthy controls
- To investigate the concurrent validity of ClinScaP and RPS in PwMS, compared with upper limb dysfunction measurements. In phase B:
- To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients.
- To investigate the interaction between trunk, scapula and upper limb impairments in PwMS and stroke patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| persons with Multiple Sclerosis | Experimental | Other: Clinical Scapular protocol (ClinScaP), Other: the prevalence of trunk, scapula and upper limb impairments., Other: the interaction between trunk, scapula and upper limb impairments. |
| Healthy controls | Active comparator | Other: Clinical Scapular protocol (ClinScaP) |
| Stroke Patients | Active comparator | Other: the prevalence of trunk, scapula and upper limb impairments., Other: the interaction between trunk, scapula and upper limb impairments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with MS (Multiple Sclerosis) using McDonald criteria
- Able to move at least 1 out of 3 joints (wrist, elbow or shoulder): Medical Research Council score 3.
- First- ever single, unilateral (ischemic or hemorrhagic) stroke
- No apraxia or hemi spatial neglect
- Able to move at least 1 out of 3 joints of the affected upper limb (wrist, elbow or shoulder): Medical Research Council score 3.
Key exclusion criteria (4 listed)
- Other medical conditions interfering with the upper limb function or trunk (orthopedic or rheumatoid impairment)
- Perceived pain in one of the upper limbs of more than 4/10 (Visual Analog Scale)
- Severe cognitive or visual deficits interfering with testing
- For the PwMS: a relapse or relapse-related treatment in the last month prior to the study
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 |
|---|---|---|
| Clinical Scapular protocol (ClinScaP)the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS and healthy controls. | Other | Healthy controls, persons with Multiple Sclerosis |
| the prevalence of trunk, scapula and upper limb impairments.To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients. | Other | Stroke Patients, persons with Multiple Sclerosis |
| the interaction between trunk, scapula and upper limb impairments.To investigate the interaction between trunk, scapula and upper limb impairments in PwMS and stroke patients. | Other | Stroke Patients, persons with Multiple Sclerosis |
Primary outcome
The Reaching performance scale (RPS)
Time frame: baseline
The Reaching performance scale (RPS) evaluates 6 components during reaching to a cup. The first four components: 1. trunk displacement, 2. movement smoothness, 3. shoulder movements, and 4. elbow movements. The components are evaluated during reaching movements to targets placed close or far from the person. The 2 additional components globally rate 5. the quality of prehension and 6. the accomplishment of the task.
The Reaching performance scale (RPS)
Time frame: Day 1
The Reaching performance scale (RPS) evaluates 6 components during reaching to a cup. The first four components: 1. trunk displacement, 2. movement smoothness, 3. shoulder movements, and 4. elbow movements. The components are evaluated during reaching movements to targets placed close or far from the person. The 2 additional components globally rate 5. the quality of prehension and 6. the accomplishment of the task.
The clinical scapular protocol
Time frame: Baseline
The clinical scapular protocol consists of five items. A score is given between 0 and 2, based on observation of tilting and winging, shoulder girdle position (measuring acromial and pectoralis minor index and scapular distance test), scapular lateral rotation, maximal active humeral elevation, medial rotation test
The clinical scapular protocol
Time frame: day 1
The clinical scapular protocol consists of five items. A score is given between 0 and 2, based on observation of tilting and winging, shoulder girdle position (measuring acromial and pectoralis minor index and scapular distance test), scapular lateral rotation, maximal active humeral elevation, medial rotation test
30 secondary outcomes
Trunk Impairment Scale
Time frame: Baseline
Trunk Impairment Scale
Time frame: day 1
Box and Block test
Time frame: Baseline
Box and Block test
Time frame: day 1
The Brunnström Fugl Meyer (BFM)
Time frame: Baseline
The Brunnström Fugl Meyer (BFM)
Time frame: day 1
The Action Research Arm Test (ARAT)
Time frame: Baseline
The Action Research Arm Test (ARAT)
Time frame: day 1
The Nine Hole Peg Test (NHPT)
Time frame: baseline
The Nine Hole Peg Test (NHPT)
Time frame: day 1
The Manual Ability Measure-36 (MAM-36)
Time frame: baseline
The Manual Ability Measure-36 (MAM-36)
Time frame: day 1
Arm Function in Multiple Sclerosis Questionnaire
Time frame: Baseline
Arm Function in Multiple Sclerosis Questionnaire
Time frame: Day 1
Active and passive range of motion of shoulder, elbow and wrist movement
Time frame: Baseline
Active and passive range of motion of shoulder, elbow and wrist movement
Time frame: Day 1
Modified Ashworth Scale
Time frame: Baseline
Modified Ashworth Scale
Time frame: day 1
Maximal hand grip strength test (HGS)
Time frame: Baseline
Maximal hand grip strength HGS)
Time frame: Day 1
Symbol digit modalities test
Time frame: Baseline
Symbol digit modalities test
Time frame: Day 1
Modified fatigue impact scale
Time frame: Baseline
Modified fatigue impact scale
Time frame: Day 1
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Baseline
National Institutes of Health Stroke Scale (NIHSS)
Time frame: Day 1
10 Meter loop test (10MWT)
Time frame: baseline
10 Meter loop test (10MWT)
Time frame: Day 1
Modified Rankin Scale (MRS)
Time frame: Baseline
Modified Rankin Scale (MRS)
Time frame: day 1
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 12 Jul 2024.
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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.
Ilse Lamers, dr. study chair
Hasselt University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Scapular protocol (ClinScaP), the prevalence of trunk, scapula and upper limb impairments. and the interaction between trunk, scapula and upper limb impairments. in people with Multiple Sclerosis and Stroke, run by Hasselt University at 4 sites 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 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The Reaching performance scale (RPS) (time frame: baseline). The study lists 4 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 12 Jul 2024.