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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908891
• Other study ID #: Neuro-JR-001
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: August 2021
• Source: Hasselt University
• Contact: Peter Feys, prof. dr.
• Phone: +32 11 29 21 23
• Email: peter.feys[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Stroke

Intervention

Other:
• Clinical Scapular protocol (ClinScaP)
the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS and healthy controls.
• 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.
• 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.

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Jessa Ziekenhuis- Campus St. Ursula	Herk-de-Stad
Belgium	National MS Center Melsbroek	Melsbroek
Belgium	Noorderhart MS & Revalidatie	Overpelt

Sponsors (5)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital, National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

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