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

July 1, 2022 updated by: University Hospital, Ghent

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

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Gent, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Stroke patient from inpatient or outpatient rehabilitation centers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stroke group
Stroke patients who can walk independently for at least 10 meters without rest. Unilateral walking aids are allowed.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single point of assessment within one week after the 2D video has been made
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.
Assessment at 2 points in time with an interval of 2 weeks.
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.
Single point of assessment within one week
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)
Single point of assessment within one week after the 2D video has been made

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Single point of assessment at assessment day 1
Fugl Meyer assessment upper limb section
Time Frame: Single point of assessment at assessment day 1
Active recovery of the upper limb
Single point of assessment at assessment day 1
Fugl Meyer assessment lower limb section
Time Frame: Single point of assessment at assessment day 1
Active recovery of the lower limb
Single point of assessment at assessment day 1
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
Single point of assessment at assessment day 1
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)
Single point of assessment at assessment day 1
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
Single point of assessment at assessment day 1
Shoulder subluxation (palpation)
Time Frame: Single point of assessment at assessment day 1
Palpating the gap between the acromion and the humeral head
Single point of assessment at assessment day 1
Trunk control
Time Frame: Single point of assessment at assessment day 1
Assessing the trunk impairment using the trunk impairment scale
Single point of assessment at assessment day 1
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
Single point of assessment at assessment day 1
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
Single point of assessment at assessment day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

March 16, 2022

Study Completion (Actual)

March 16, 2022

Study Registration Dates

First Submitted

October 25, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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