Clinical trial NCT04908891: A Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness
Official title: A Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Stroke
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
name: Ziekenhuis Oost-Limburg
name: National MS Center Melsbroek
name: Jessa Hospital
First posted: 2021-06-01
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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. 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.


Eligibility 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

Primary outcomes:
measure: The Reaching performance scale (RPS)
timeFrame: baseline
measure: The Reaching performance scale (RPS)
timeFrame: Day 1
measure: The clinical scapular protocol
timeFrame: Baseline
measure: The clinical scapular protocol
timeFrame: day 1
Secondary outcomes:
measure: Trunk Impairment Scale
timeFrame: Baseline
measure: Trunk Impairment Scale
timeFrame: day 1
measure: Box and Block test
timeFrame: Baseline
measure: Box and Block test
timeFrame: day 1
measure: The Brunnström Fugl Meyer (BFM)
timeFrame: Baseline
measure: The Brunnström Fugl Meyer (BFM)
timeFrame: day 1
measure: The Action Research Arm Test (ARAT)
timeFrame: Baseline
measure: The Action Research Arm Test (ARAT)
timeFrame: day 1
measure: The Nine Hole Peg Test (NHPT)
timeFrame: baseline
measure: The Nine Hole Peg Test (NHPT)
timeFrame: day 1
measure: The Manual Ability Measure-36 (MAM-36)
timeFrame: baseline
measure: The Manual Ability Measure-36 (MAM-36)
timeFrame: day 1
measure: Arm Function in Multiple Sclerosis Questionnaire
timeFrame: Baseline
measure: Arm Function in Multiple Sclerosis Questionnaire
timeFrame: Day 1
measure: Active and passive range of motion of shoulder, elbow and wrist movement
timeFrame: Baseline
measure: Active and passive range of motion of shoulder, elbow and wrist movement
timeFrame: Day 1
measure: Modified Ashworth Scale
timeFrame: Baseline
measure: Modified Ashworth Scale
timeFrame: day 1
measure: Maximal hand grip strength test (HGS)
timeFrame: Baseline
measure: Maximal hand grip strength HGS)
timeFrame: Day 1
measure: Symbol digit modalities test
timeFrame: Baseline
measure: Symbol digit modalities test
timeFrame: Day 1
measure: Modified fatigue impact scale
timeFrame: Baseline
measure: Modified fatigue impact scale
timeFrame: Day 1
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Baseline
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Day 1
measure: 10 Meter loop test (10MWT)
timeFrame: baseline
measure: 10 Meter loop test (10MWT)
timeFrame: Day 1
measure: Modified Rankin Scale (MRS)
timeFrame: Baseline
measure: Modified Rankin Scale (MRS)
timeFrame: day 1
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Herk-de-Stad
country: Belgium
facility: Jessa Ziekenhuis- Campus St. Ursula
city: Melsbroek
country: Belgium
facility: National MS Center Melsbroek
city: Overpelt
country: Belgium
facility: Noorderhart MS & Revalidatie
Study officials:
affiliation: Hasselt University
name: Ilse Lamers, dr.
role: STUDY_CHAIR
References: