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

H

Hasselt University

Status

Completed

Conditions

Stroke
Multiple Sclerosis

Treatments

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

Funder types

Other

Identifiers

NCT04908891
Neuro-JR-001

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

78 participants in 3 patient groups

persons with Multiple Sclerosis
Experimental group
Treatment:
Other: the interaction between trunk, scapula and upper limb impairments.
Other: the prevalence of trunk, scapula and upper limb impairments.
Other: Clinical Scapular protocol (ClinScaP)
Healthy controls
Active Comparator group
Treatment:
Other: Clinical Scapular protocol (ClinScaP)
Stroke Patients
Active Comparator group
Treatment:
Other: the interaction between trunk, scapula and upper limb impairments.
Other: the prevalence of trunk, scapula and upper limb impairments.

Trial contacts and locations

4

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Central trial contact

Peter Feys, prof. dr.; Joke Raats, drs

Data sourced from clinicaltrials.gov

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