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Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04908891
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hasselt University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ilse Lamers, dr.
Principal Investigator Affiliation	Hasselt University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Stroke

Arms & Interventions

Arms

Experimental: persons with Multiple Sclerosis

Active Comparator: Healthy controls

Active Comparator: Stroke Patients

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.