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Completed

NCT Number: NCT04908891

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg, Genk, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Scapular protocol (ClinScaP)

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.

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.

Other

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

Primary outcomes

  1. The Reaching performance scale (RPS)

    Time frame: baseline

    The Reaching performance scale (RPS) evaluates 6 components during reaching to a cup. The first four components:

    • trunk displacement,
    • movement smoothness,
    • shoulder movements, and
    • elbow movements. The components are evaluated during reaching movements to targets placed close or far from the person. The 2 additional components globally rate
    • the quality of prehension and
    • the accomplishment of the task.

  2. The Reaching performance scale (RPS)

    Time frame: Day 1

    The Reaching performance scale (RPS) evaluates 6 components during reaching to a cup. The first four components:

    • trunk displacement,
    • movement smoothness,
    • shoulder movements, and
    • elbow movements. The components are evaluated during reaching movements to targets placed close or far from the person. The 2 additional components globally rate
    • the quality of prehension and
    • the accomplishment of the task.

  3. The clinical scapular protocol

    Time frame: Baseline

    The 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

  4. The clinical scapular protocol

    Time frame: day 1

    The 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 outcomes

  1. Trunk Impairment Scale

    Time frame: Baseline

    Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.

  2. Trunk Impairment Scale

    Time frame: day 1

    Trunk Impairment Scale used to measure static and dynamic sitting balance and trunk coordination in a sitting position.

  3. Box and Block test

    Time frame: Baseline

    This 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.

  4. Box and Block test

    Time frame: day 1

    This 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.

  5. The Brunnström Fugl Meyer (BFM)

    Time frame: Baseline

    The 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.

  6. The Brunnström Fugl Meyer (BFM)

    Time frame: day 1

    The 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.

  7. The Action Research Arm Test (ARAT)

    Time frame: Baseline

    Action 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

  8. The Action Research Arm Test (ARAT)

    Time frame: day 1

    Action 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

  9. The Nine Hole Peg Test (NHPT)

    Time frame: baseline

    The Nine Hole Peg Test (NHPT) was used to assess manual dexterity by the time needed to place and remove nine pegs in a board.

  10. The Nine Hole Peg Test (NHPT)

    Time frame: day 1

    The Nine Hole Peg Test (NHPT) was used to assess manual dexterity by the time needed to place and remove nine pegs in a board.

  11. The Manual Ability Measure-36 (MAM-36)

    Time frame: baseline

    The 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.

  12. The Manual Ability Measure-36 (MAM-36)

    Time frame: day 1

    The 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.

  13. Arm Function in Multiple Sclerosis Questionnaire

    Time frame: Baseline

    : A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis

  14. Arm Function in Multiple Sclerosis Questionnaire

    Time frame: Day 1

    : A Questionnaire Fatigue to evaluate the perceived performance of Arm Function in Multiple Sclerosis

  15. Active and passive range of motion of shoulder, elbow and wrist movement

    Time frame: Baseline

    Active and passive range of motion of shoulder, elbow and wrist movement is measured with a goniometer Safety Issue?: Yes/No

  16. Active and passive range of motion of shoulder, elbow and wrist movement

    Time frame: Day 1

    Active and passive range of motion of shoulder, elbow and wrist movement is measured with a goniometer Safety Issue?: Yes/No

  17. Modified Ashworth Scale

    Time frame: Baseline

    Spasticity is evaluated with Modified Ashworth Scale

  18. Modified Ashworth Scale

    Time frame: day 1

    Spasticity is evaluated with Modified Ashworth Scale

  19. Maximal hand grip strength test (HGS)

    Time frame: Baseline

    HGS 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.

  20. Maximal hand grip strength HGS)

    Time frame: Day 1

    HGS 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.

  21. Symbol digit modalities test

    Time frame: Baseline

    Information of processing speed with the Symbol digit modalities test

  22. Symbol digit modalities test

    Time frame: Day 1

    Information of processing speed with the Symbol digit modalities test

  23. Modified fatigue impact scale

    Time frame: Baseline

    : Fatigue is evaluated a questionnaire: the modified fatigue impact scale

  24. Modified fatigue impact scale

    Time frame: Day 1

    : Fatigue is evaluated a questionnaire: the modified fatigue impact scale

  25. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: Baseline

    The 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

  26. National Institutes of Health Stroke Scale (NIHSS)

    Time frame: Day 1

    The 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

  27. 10 Meter loop test (10MWT)

    Time frame: baseline

    The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)

  28. 10 Meter loop test (10MWT)

    Time frame: Day 1

    The 10MWT assesses walking speed in meters per second over a short duration. (specific for stroke)

  29. Modified Rankin Scale (MRS)

    Time frame: Baseline

    The 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

  30. Modified Rankin Scale (MRS)

    Time frame: day 1

    The 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

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital
  • National MS Center Melsbroek
  • Revalidatie & MS Centrum Overpelt
  • Ziekenhuis Oost-Limburg

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jun 1, 2021
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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