A Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness

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. To investigate the test-retest reliability of the Clinical Scapular Protocol (ClinScaP) and the Reaching Performance Scale (RPS) in PwMS
2. To investigate the discriminative of the ClinScaP between PwMS and healthy controls
3. To investigate the discriminative of the RPS between PwMS and healthy controls

4. To investigate the concurrent validity of ClinScaP and RPS in PwMS, compared with upper limb dysfunction measurements.

   In phase B:

5. To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients.
6. To investigate the interaction between trunk, scapula and upper limb impairments in PwMS and stroke patients.

Study Overview

• Status: Completed
• Conditions: Stroke; Multiple Sclerosis
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Herk-de-Stad, Belgium, 3540
    • Jessa Ziekenhuis- Campus St. Ursula
  • Melsbroek, Belgium, 1820
    • National MS Center Melsbroek
  • Overpelt, Belgium, 3900
    • Noorderhart MS & Revalidatie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: persons with Multiple Sclerosis	Other: Clinical Scapular protocol (ClinScaP); the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS and healthy controls.; Other: 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: 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.
Active Comparator: Healthy controls	Other: Clinical Scapular protocol (ClinScaP); the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS and healthy controls.
Active Comparator: Stroke Patients	Other: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trunk Impairment Scale	Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.	Baseline
Trunk Impairment Scale	Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.	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.	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.	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.	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.	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	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	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.	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.	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.	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.	day 1
Arm Function in Multiple Sclerosis Questionnaire	: A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis	Baseline
Arm Function in Multiple Sclerosis Questionnaire	: A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis	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	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	Day 1
Modified Ashworth Scale	Spasticity is evaluated with Modified Ashworth Scale	Baseline
Modified Ashworth Scale	Spasticity is evaluated with Modified Ashworth Scale	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.	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.	Day 1
Symbol digit modalities test	Information of processing speed with the Symbol digit modalities test	Baseline
Symbol digit modalities test	Information of processing speed with the Symbol digit modalities test	Day 1
Modified fatigue impact scale	: Fatigue is evaluated a questionnaire: the modified fatigue impact scale	Baseline
Modified fatigue impact scale	: Fatigue is evaluated a questionnaire: the modified fatigue impact scale	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	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	Day 1
10 Meter loop test (10MWT)	The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)	baseline
10 Meter loop test (10MWT)	The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)	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	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	day 1

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Jessa Hospital; Ziekenhuis Oost-Limburg; Revalidatie & MS Centrum Overpelt; National MS Center Melsbroek
• Investigators: Study Chair: Ilse Lamers, dr., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID Numbers: Neuro-JR-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No