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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128370
• Other study ID #: BC-10309
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: March 16, 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 16, 2022
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Paresis
• Stroke
• Upper Extremity Paresis

Intervention

Other:
• Visual observation of arm swing during walking
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.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Gent

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Ghent	Algemeen Ziekenhuis Maria Middelares, Belgisch Zee Instituut Oostende

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interrater reliability of the upper limb observation scale	Intraclass correlation coefficient between the different raters who rate the same observation at the same time.	Single point of assessment within one week after the 2D video has been made
Primary	Intrarater reliability of the upper limb observation scale	Intraclass correlation coefficient between the same rater rating the videos within a period of 2 weeks from each other.	Assessment at 2 points in time with an interval of 2 weeks.
Primary	Kinematic assessment of the arm swing during walking	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.	Single point of assessment within one week
Primary	Visual observation scale for the upper limb during walking	Total score on the upper limb visual observation scale (max score 34)	Single point of assessment within one week after the 2D video has been made
Secondary	Demographic variables	Age, gender, date of birth, stroke date, type of stroke, side of paresis, stroke location	Single point of assessment at assessment day 1
Secondary	Fugl Meyer assessment upper limb section	Active recovery of the upper limb	Single point of assessment at assessment day 1
Secondary	Fugl Meyer assessment lower limb section	Active recovery of the lower limb	Single point of assessment at assessment day 1
Secondary	Upper limb spasticity (Modified Ashworth Scale)	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	Single point of assessment at assessment day 1
Secondary	Passive range of motion shoulder and elbow	Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation and elbow flexion/extension (degrees)	Single point of assessment at assessment day 1
Secondary	Sensory assessment of the upper limb	UL sensory testing using the Erasmus MC Modificatie van de (revised) Nottigham Sensory Assessment	Single point of assessment at assessment day 1
Secondary	Shoulder subluxation (palpation)	Palpating the gap between the acromion and the humeral head	Single point of assessment at assessment day 1
Secondary	Trunk control	Assessing the trunk impairment using the trunk impairment scale	Single point of assessment at assessment day 1
Secondary	Upper limb pain during walking	Using a numeric rating scale (0-10) to assess pain at the upper limb during walking	Single point of assessment at assessment day 1
Secondary	Gait speed	Calculating gait speed (m/s) based on the time it takes to complete the 10m walking	Single point of assessment at assessment day 1