Clinical trial NCT05128370: Visual Observation Scale for the Upper Limb During Walking in Patients After Stroke.
Official title: Visual Observation Scale for the Upper Limb During Walking in Patients After Stroke.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gait, Hemiplegic
Stroke
Upper Extremity Paresis
Keywords: arm swing
visual observation
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Algemeen Ziekenhuis Maria Middelares
name: Belgisch Zee Instituut Oostende
First posted: 2021-11-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke patient from inpatient or outpatient rehabilitation centers.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Interrater reliability of the upper limb observation scale
timeFrame: Single point of assessment within one week after the 2D video has been made
measure: Intrarater reliability of the upper limb observation scale
timeFrame: Assessment at 2 points in time with an interval of 2 weeks.
measure: Kinematic assessment of the arm swing during walking
timeFrame: Single point of assessment within one week
measure: Visual observation scale for the upper limb during walking
timeFrame: Single point of assessment within one week after the 2D video has been made
Secondary outcomes:
measure: Demographic variables
timeFrame: Single point of assessment at assessment day 1
measure: Fugl Meyer assessment upper limb section
timeFrame: Single point of assessment at assessment day 1
measure: Fugl Meyer assessment lower limb section
timeFrame: Single point of assessment at assessment day 1
measure: Upper limb spasticity (Modified Ashworth Scale)
timeFrame: Single point of assessment at assessment day 1
measure: Passive range of motion shoulder and elbow
timeFrame: Single point of assessment at assessment day 1
measure: Sensory assessment of the upper limb
timeFrame: Single point of assessment at assessment day 1
measure: Shoulder subluxation (palpation)
timeFrame: Single point of assessment at assessment day 1
measure: Trunk control
timeFrame: Single point of assessment at assessment day 1
measure: Upper limb pain during walking
timeFrame: Single point of assessment at assessment day 1
measure: Gait speed
timeFrame: Single point of assessment at assessment day 1
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Ghent
Study officials:
References: