Back to resultsA Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness
Primary Purpose
Multiple Sclerosis, Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Clinical Scapular protocol (ClinScaP)
the prevalence of trunk, scapula and upper limb impairments.
the interaction between trunk, scapula and upper limb impairments.
Sponsored by
About this trial
This is an interventional diagnostic trial for Multiple Sclerosis
Eligibility Criteria
Inclusion criteria for all participants: Healthy controls, PwMS (Persons with Multiple Sclerosis) and stroke patients
- Age > 18 years
- Able to understand and execute the test instructions
- Able to sit on a chair with low back support for 10 minutes
Inclusion criteria specific for PwMS:
- 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.
Inclusion criteria for stroke patients:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Ziekenhuis Oost-LimburgRecruiting
- Jessa Ziekenhuis- Campus St. UrsulaRecruiting
- National MS Center MelsbroekRecruiting
- Noorderhart MS & RevalidatieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
persons with Multiple Sclerosis
Healthy controls
Stroke Patients
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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
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
Secondary Outcome Measures
Trunk Impairment Scale
Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.
Trunk Impairment Scale
Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.
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.
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.
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.
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.
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
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
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.
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.
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.
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.
Arm Function in Multiple Sclerosis Questionnaire
: A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis
Arm Function in Multiple Sclerosis Questionnaire
: A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis
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
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
Modified Ashworth Scale
Spasticity is evaluated with Modified Ashworth Scale
Modified Ashworth Scale
Spasticity is evaluated with Modified Ashworth Scale
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.
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.
Symbol digit modalities test
Information of processing speed with the Symbol digit modalities test
Symbol digit modalities test
Information of processing speed with the Symbol digit modalities test
Modified fatigue impact scale
: Fatigue is evaluated a questionnaire: the modified fatigue impact scale
Modified fatigue impact scale
: Fatigue is evaluated a questionnaire: the modified fatigue impact scale
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
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
10 Meter loop test (10MWT)
The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)
10 Meter loop test (10MWT)
The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)
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
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
Full Information
NCT ID
NCT04908891
First Posted
May 26, 2021
Last Updated
August 12, 2021
Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg, National MS Center Melsbroek, Jessa Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04908891
Brief Title
A Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness
Official Title
A Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
August 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg, National MS Center Melsbroek, Jessa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Stroke
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
persons with Multiple Sclerosis
Arm Type
Experimental
Arm Title
Healthy controls
Arm Type
Active Comparator
Arm Title
Stroke Patients
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Clinical Scapular protocol (ClinScaP)
Intervention Description
the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS and healthy controls.
Intervention Type
Other
Intervention Name(s)
the prevalence of trunk, scapula and upper limb impairments.
Intervention Description
To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients.
Intervention Type
Other
Intervention Name(s)
the interaction between trunk, scapula and upper limb impairments.
Intervention Description
To investigate the interaction between trunk, scapula and upper limb impairments in PwMS and stroke patients.
Primary Outcome Measure Information:
Title
The Reaching performance scale (RPS)
Description
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.
Time Frame
baseline
Title
The Reaching performance scale (RPS)
Description
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.
Time Frame
Day 1
Title
The clinical scapular protocol
Description
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
Time Frame
Baseline
Title
The clinical scapular protocol
Description
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
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Trunk Impairment Scale
Description
Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.
Time Frame
Baseline
Title
Trunk Impairment Scale
Description
Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.
Time Frame
day 1
Title
Box and Block test
Description
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.
Time Frame
Baseline
Title
Box and Block test
Description
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.
Time Frame
day 1
Title
The Brunnström Fugl Meyer (BFM)
Description
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.
Time Frame
Baseline
Title
The Brunnström Fugl Meyer (BFM)
Description
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.
Time Frame
day 1
Title
The Action Research Arm Test (ARAT)
Description
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
Time Frame
Baseline
Title
The Action Research Arm Test (ARAT)
Description
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
Time Frame
day 1
Title
The Nine Hole Peg Test (NHPT)
Description
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.
Time Frame
baseline
Title
The Nine Hole Peg Test (NHPT)
Description
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.
Time Frame
day 1
Title
The Manual Ability Measure-36 (MAM-36)
Description
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.
Time Frame
baseline
Title
The Manual Ability Measure-36 (MAM-36)
Description
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.
Time Frame
day 1
Title
Arm Function in Multiple Sclerosis Questionnaire
Description
: A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis
Time Frame
Baseline
Title
Arm Function in Multiple Sclerosis Questionnaire
Description
: A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis
Time Frame
Day 1
Title
Active and passive range of motion of shoulder, elbow and wrist movement
Description
Active and passive range of motion of shoulder, elbow and wrist movement is measured with a goniometer Safety Issue?: Yes/No
Time Frame
Baseline
Title
Active and passive range of motion of shoulder, elbow and wrist movement
Description
Active and passive range of motion of shoulder, elbow and wrist movement is measured with a goniometer Safety Issue?: Yes/No
Time Frame
Day 1
Title
Modified Ashworth Scale
Description
Spasticity is evaluated with Modified Ashworth Scale
Time Frame
Baseline
Title
Modified Ashworth Scale
Description
Spasticity is evaluated with Modified Ashworth Scale
Time Frame
day 1
Title
Maximal hand grip strength test (HGS)
Description
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.
Time Frame
Baseline
Title
Maximal hand grip strength HGS)
Description
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.
Time Frame
Day 1
Title
Symbol digit modalities test
Description
Information of processing speed with the Symbol digit modalities test
Time Frame
Baseline
Title
Symbol digit modalities test
Description
Information of processing speed with the Symbol digit modalities test
Time Frame
Day 1
Title
Modified fatigue impact scale
Description
: Fatigue is evaluated a questionnaire: the modified fatigue impact scale
Time Frame
Baseline
Title
Modified fatigue impact scale
Description
: Fatigue is evaluated a questionnaire: the modified fatigue impact scale
Time Frame
Day 1
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
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
Time Frame
Baseline
Title
National Institutes of Health Stroke Scale (NIHSS)
Description
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
Time Frame
Day 1
Title
10 Meter loop test (10MWT)
Description
The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)
Time Frame
baseline
Title
10 Meter loop test (10MWT)
Description
The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)
Time Frame
Day 1
Title
Modified Rankin Scale (MRS)
Description
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
Time Frame
Baseline
Title
Modified Rankin Scale (MRS)
Description
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
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for all participants: Healthy controls, PwMS (Persons with Multiple Sclerosis) and stroke patients
Age > 18 years
Able to understand and execute the test instructions
Able to sit on a chair with low back support for 10 minutes
Inclusion criteria specific for PwMS:
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.
Inclusion criteria for stroke patients:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Feys, prof. dr.
Phone
+32 11 29 21 23
Email
peter.feys@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Joke Raats, drs
Phone
+32 11 29 21 29
Email
joke.raats@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilse Lamers, dr.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk Bieghs
Phone
+32 89 32 63 31
Email
dirk.bieghs@zol.be
First Name & Middle Initial & Last Name & Degree
Joke Raats, drs
Phone
+32 11 29 21 29
Email
joke.raats@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Dirk Bieghs
Facility Name
Jessa Ziekenhuis- Campus St. Ursula
City
Herk-de-Stad
ZIP/Postal Code
3540
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Michielsen
Phone
+32 13 55 06 57
Email
marc.michielsen@jessazh.be
First Name & Middle Initial & Last Name & Degree
Joke Raats, drs.
Phone
+32 11 29 21 29
Email
joke.raats@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Marc Michielsen
Facility Name
National MS Center Melsbroek
City
Melsbroek
ZIP/Postal Code
1820
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofie Ferdinand
Phone
+32 2 597 86 90
Email
sofie.ferdinand@mscenter.be
First Name & Middle Initial & Last Name & Degree
Joke Raats, drs.
Phone
+32 11 29 21 29
Email
joke.raats@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Sofie Ferdinand
Facility Name
Noorderhart MS & Revalidatie
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bart Van Wijmeersch, prof.dr
Phone
+32 11 80 91 00
Email
bart.vanwijmeersch@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Joke Raats, drs.
Phone
+32 11 29 21 29
Email
joke.raats@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Bart Van Wijmeersch, prof. dr.
First Name & Middle Initial & Last Name & Degree
Ilse Lamers, dr.
12. IPD Sharing Statement
Learn more about this trial
A Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness
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