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Completed

NCT Number: NCT05128370

Visual Observation Scale for the Upper Limb During Walking in Patients After Stroke.

For several years now, it has been demonstrated that the upper limb plays an important role in the function of an efficient and balanced gait pattern in healthy adults. After a stroke, the reduced muscle strength has a clear influence on the gait pattern, but also on the active movement possibilities of the upper limb. However, the role of the upper limb during gait is not sufficiently explored in the literature. The gold standard for motion analysis is a 3D analysis performed with infrared cameras capturing reflective markers during gait. Unfortunately, it is not possible for all people after a stroke to undergo this examination. On the one hand, patients must already have a certain degree of independence with regard to gait. On the other hand, not all centers have access to this expensive accommodation. There are some validated observation scales for people after stroke to describe the gait based on a 2D video image. This method is much more accessible and can be applied by any therapist. However, to date there has been little attention paid to the upper limb in these observation scales. Therefore, analogous to the observation scales for gait, an observation scale for the upper limb during gait was set up. The use of this scale can add value to the rehabilitation of people after a stroke.

* The treatment team will receive information about the patient's complete movement pattern. * The arm will be more prominent when setting rehabilitation goals related to gait. This can lead to a positive effect on the gait pattern itself, but also to more attention being paid to the arm, which has a more difficult recovery than the leg after a stroke.

The aim of the current study will be

* to determine the inter and intra tester reliability of this visual observation scale * to investigate if the results of the visual observation scale correlate to a 3D assessment performed in a subgroup of participants

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Key information

About this study

Patients will be walking for 4x10 m. During this walking a 2D video recording in the frontal (back and front view) and sagittal plane (left and right sided view) will be performed.

Supervision of therapist during walking is allowed. Therapist cannot help the patient during walking.

This images will be used to score the visual observation scale (G.A.I.T) and the additional observation scale developed for this study.

In a subgroup of participants from the Ghent University Hospital, a 3D assessment will be made on an instrumented treadmill (GRAIL, Motek), which will be used as a golden standard to compare with.

Additional clinical parameters will be investigated to describe the study group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All stroke patients who are able to walk with or without the use of a unilateral walking device (stick, tripod) for at least 10 m.
  • Normal ambulation prior to stroke.
  • Unilateral stroke.

Exclusion criteria

  • Other neurologic conditions.
  • Orthopedic conditions that influence gait.
  • Visual impairments that impede independent walking.
  • Cerebellar stroke

Treatment and study plan

Visual observation of arm swing during walking

Other

The gait pattern of the stroke patients will be scored based on a visual observation scale. Additional components concerning the arm swing have been added to an existing scale.

Primary outcomes

  1. Interrater reliability of the upper limb observation scale

    Time frame: Single point of assessment within one week after the 2D video has been made

    Intraclass correlation coefficient between the different raters who rate the same observation at the same time.

  2. Intrarater reliability of the upper limb observation scale

    Time frame: Assessment at 2 points in time with an interval of 2 weeks.

    Intraclass correlation coefficient between the same rater rating the videos within a period of 2 weeks from each other.

  3. Kinematic assessment of the arm swing during walking

    Time frame: Single point of assessment within one week

    Correlation statistics between items of the upper limb observation scale and kinematic graphs of the 3D assessment which will be performed within a week after the 2D assessment.

  4. Visual observation scale for the upper limb during walking

    Time frame: Single point of assessment within one week after the 2D video has been made

    Total score on the upper limb visual observation scale (max score 34)

Secondary outcomes

  1. Demographic variables

    Time frame: Single point of assessment at assessment day 1

    Age, gender, date of birth, stroke date, type of stroke, side of paresis, stroke location

  2. Fugl Meyer assessment upper limb section

    Time frame: Single point of assessment at assessment day 1

    Active recovery of the upper limb

  3. Fugl Meyer assessment lower limb section

    Time frame: Single point of assessment at assessment day 1

    Active recovery of the lower limb

  4. Upper limb spasticity (Modified Ashworth Scale)

    Time frame: Single point of assessment at assessment day 1

    Modified Ashworth Scale (minimum 0 - maximum 4, higher score is more spasticity = worse outcome) of shoulder flexors, extensors, internal rotators, external rotators, adductors, abductors, elbow flexors, elbow extensors, wrist flexors, wrist extensors, finger flexors and finger extensors

  5. Passive range of motion shoulder and elbow

    Time frame: Single point of assessment at assessment day 1

    Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation and elbow flexion/extension (degrees)

  6. Sensory assessment of the upper limb

    Time frame: Single point of assessment at assessment day 1

    UL sensory testing using the Erasmus MC Modificatie van de (revised) Nottigham Sensory Assessment

  7. Shoulder subluxation (palpation)

    Time frame: Single point of assessment at assessment day 1

    Palpating the gap between the acromion and the humeral head

  8. Trunk control

    Time frame: Single point of assessment at assessment day 1

    Assessing the trunk impairment using the trunk impairment scale

  9. Upper limb pain during walking

    Time frame: Single point of assessment at assessment day 1

    Using a numeric rating scale (0-10) to assess pain at the upper limb during walking

  10. Gait speed

    Time frame: Single point of assessment at assessment day 1

    Calculating gait speed (m/s) based on the time it takes to complete the 10m walking

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Algemeen Ziekenhuis Maria Middelares
  • Belgisch Zee Instituut Oostende

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 22, 2021
Registry last updated
Jul 5, 2022

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

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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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