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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04908891
Enrollment
78
Registered
2021-06-01
Start date
2018-12-12
Completion date
2022-08-30
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Stroke

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.

Interventions

OTHERClinical Scapular protocol (ClinScaP)

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

OTHERthe prevalence of trunk, scapula and upper limb impairments.

To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients.

OTHERthe interaction between trunk, scapula and upper limb impairments.

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

Sponsors

Revalidatie & MS Centrum Overpelt
CollaboratorOTHER
Ziekenhuis Oost-Limburg
CollaboratorOTHER
National MS Center Melsbroek
CollaboratorOTHER
Jessa Hospital
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The Reaching performance scale (RPS)baselineThe 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.
The clinical scapular protocolBaselineThe 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

Secondary

MeasureTime frameDescription
The Brunnström Fugl Meyer (BFM)BaselineThe Brunnström Fugl Meyer (BFM) used to measure motor control at the body functions and structures level. The upper limb section is applied: shoulder, elbow, forearm, wrist movements and grip.
The Action Research Arm Test (ARAT)BaselineAction Research arm test, which assessed the patient's ability to handle objects varying in size, weight and shape. The Action Research Arm Test (ARAT) assess the ability to manipulate objects in different size, weight and shape and finally results in a maximum score of 57
The Manual Ability Measure-36 (MAM-36)baselineThe Manual Ability Measure-36 (MAM-36) was used to assess perceived upper limb performance. The sum score is converted and resulted in a score between 0-100, with 100 as a perfect manual ability.
The Nine Hole Peg Test (NHPT)baselineThe Nine Hole Peg Test (NHPT) was used to assess manual dexterity by the time needed to place and remove nine pegs in a board.
Arm Function in Multiple Sclerosis QuestionnaireBaseline: A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis
Active and passive range of motion of shoulder, elbow and wrist movementBaselineActive and passive range of motion of shoulder, elbow and wrist movement is measured with a goniometer Safety Issue?: Yes/No
Modified Ashworth ScaleBaselineSpasticity is evaluated with Modified Ashworth Scale
Trunk Impairment ScaleBaselineTrunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.
Maximal hand grip strength HGS)Day 1HGS was assessed with the Jamar digital HGD (the hand grip dynamometer). Each participant performed three maximum contractions of each hand on three handle positions progressing from first to third position.
Symbol digit modalities testBaselineInformation of processing speed with the Symbol digit modalities test
Modified fatigue impact scaleBaseline: Fatigue is evaluated a questionnaire: the modified fatigue impact scale
National Institutes of Health Stroke Scale (NIHSS)BaselineThe National Institutes of Health Stroke Scale is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment.\[1\] The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0
10 Meter loop test (10MWT)baselineThe 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)
Modified Rankin Scale (MRS)BaselineThe modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke
Maximal hand grip strength test (HGS)BaselineHGS was assessed with the Jamar digital HGD (the hand grip dynamometer). Each participant performed three maximum contractions of each hand on three handle positions progressing from first to third position.
Box and Block testBaselineThis test assess gross manual dexterity by grasping each time one block and transporting the block to the other side over a wooden panel for one minute, while sitting.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026