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

NCT ID: NCT04908891

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2022-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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persons with Multiple Sclerosis

Group Type EXPERIMENTAL

Clinical Scapular protocol (ClinScaP)

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

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

Healthy controls

Group Type ACTIVE_COMPARATOR

Clinical Scapular protocol (ClinScaP)

Intervention Type OTHER

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

Stroke Patients

Group Type ACTIVE_COMPARATOR

the prevalence of trunk, scapula and upper limb impairments.

Intervention Type 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.

Intervention Type OTHER

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

Interventions

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Clinical Scapular protocol (ClinScaP)

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

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Revalidatie & MS Centrum Overpelt

OTHER

Sponsor Role collaborator

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role collaborator

National MS Center Melsbroek

OTHER

Sponsor Role collaborator

Jessa Hospital

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Peter Feys

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ilse Lamers, dr.

Role: STUDY_CHAIR

Hasselt University

Locations

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Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status

Jessa Ziekenhuis- Campus St. Ursula

Herk-de-Stad, , Belgium

Site Status

National MS Center Melsbroek

Melsbroek, , Belgium

Site Status

Noorderhart MS & Revalidatie

Overpelt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Neuro-JR-001

Identifier Type: -

Identifier Source: org_study_id

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