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

NCT04908891 | Completed

• 1 other identifier: Neuro-JR-001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 4

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.

1. 1.To investigate the test-retest reliability of the Clinical Scapular Protocol (ClinScaP) and the Reaching Performance Scale (RPS) in PwMS
2. 2.To investigate the discriminative of the ClinScaP between PwMS and healthy controls
3. 3.To investigate the discriminative of the RPS between PwMS and healthy controls
4. 4.To investigate the concurrent validity of ClinScaP and RPS in PwMS, compared with upper limb dysfunction measurements.
5. 5.To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients.
6. 6.To investigate the interaction between trunk, scapula and upper limb impairments in PwMS and stroke patients.

Conditions

Multiple Sclerosis; Stroke

Outcome Measures

Primary Outcomes (4)

• The Reaching performance scale (RPS)

  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.

  baseline

• The Reaching performance scale (RPS)

  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.

  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 Outcomes (30)

• Trunk Impairment Scale

  Baseline

• Trunk Impairment Scale

  day 1

• Box and Block test

  Baseline

• Box and Block test

  day 1

• The Brunnström Fugl Meyer (BFM)

  Baseline

Study Arms (3)

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.

Interventions

Clinical Scapular protocol (ClinScaP) OTHER

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

Healthy controls; persons with Multiple Sclerosis

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.

Stroke Patients; persons with Multiple Sclerosis

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.

Stroke Patients; persons with Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Able to understand and execute the test instructions
• Able to sit on a chair with low back support for 10 minutes
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead
• Revalidatie & MS Centrum Overpelt: collaborator
• Ziekenhuis Oost-Limburg: collaborator
• National MS Center Melsbroek: collaborator
• Jessa Hospital: collaborator

Study Sites (4)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Jessa Ziekenhuis- Campus St. Ursula

Herk-de-Stad, 3540, Belgium

Location

National MS Center Melsbroek

Melsbroek, 1820, Belgium

Location

Noorderhart MS & Revalidatie

Overpelt, 3900, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis; Stroke

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ilse Lamers, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: December 12, 2018
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2022
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

BE (4)