Gait, HemiplegicNCT05128370
Visual Observation Scale for the Upper Limb During Walking in Patients After Stroke.
An observational study of Gait, Hemiplegic and Stroke, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gait, Hemiplegic, Stroke, Upper Extremity Paresis
- What is being tested?
- Visual observation of arm swing during walking
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Dec 2021to 16 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patient from inpatient or outpatient rehabilitation centers.
Who may be able to join
- 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.
Who cannot join
- Other neurologic conditions.
- Orthopedic conditions that influence gait.
- Visual impairments that impede independent walking.
- Cerebellar stroke
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the 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.
- Conditions
- Gait, Hemiplegic, Stroke, Upper Extremity Paresis
- Being tested
- Visual observation of arm swing during walking
- Keywords
- arm swing, visual observation
- Medical subject headings
- Gait Disorders, Neurologic, Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual observation of arm swing during walkingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroke group | Stroke patients who can walk independently for at least 10 meters without rest. Unilateral walking aids are allowed. Receives: Other: Visual observation of arm swing during walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interrater reliability of the upper limb observation scale
Intraclass correlation coefficient between the different raters who rate the same observation at the same time.
Measured: Single point of assessment within one week after the 2D video has been made
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.
Measured: Assessment at 2 points in time with an interval of 2 weeks.
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.
Measured: Single point of assessment within one week
Visual observation scale for the upper limb during walking
Total score on the upper limb visual observation scale (max score 34)
Measured: Single point of assessment within one week after the 2D video has been made
Secondary outcomes (10)
Demographic variables
Age, gender, date of birth, stroke date, type of stroke, side of paresis, stroke location
Measured: Single point of assessment at assessment day 1
Fugl Meyer assessment upper limb section
Active recovery of the upper limb
Measured: Single point of assessment at assessment day 1
Fugl Meyer assessment lower limb section
Active recovery of the lower limb
Measured: Single point of assessment at assessment day 1
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
Measured: Single point of assessment at assessment day 1
Passive range of motion shoulder and elbow
Goniometric measurement of shoulder flexion, abduction, external rotation, internal rotation and elbow flexion/extension (degrees)
Measured: Single point of assessment at assessment day 1
Sensory assessment of the upper limb
UL sensory testing using the Erasmus MC Modificatie van de (revised) Nottigham Sensory Assessment
Measured: Single point of assessment at assessment day 1
Shoulder subluxation (palpation)
Palpating the gap between the acromion and the humeral head
Measured: Single point of assessment at assessment day 1
Trunk control
Assessing the trunk impairment using the trunk impairment scale
Measured: Single point of assessment at assessment day 1
Upper limb pain during walking
Using a numeric rating scale (0-10) to assess pain at the upper limb during walking
Measured: Single point of assessment at assessment day 1
Gait speed
Calculating gait speed (m/s) based on the time it takes to complete the 10m walking
Measured: Single point of assessment at assessment day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start1 Dec 2021
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait, HemiplegicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares, Belgisch Zee Instituut Oostende
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128370
- Sponsor's protocol ID
- BC-10309
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Observation Scale for the Upper Limb During Walking in Patients After Stroke.
- ClinicalTrials.gov ID
- NCT05128370
- Acronym / sponsor ID
- BC-10309
- Conditions
- Gait, Hemiplegic, Stroke, Upper Extremity Paresis
- Keywords
- arm swing, visual observation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares, Belgisch Zee Instituut Oostende
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke group | – | Other: Visual observation of arm swing during walkingStroke patients who can walk independently for at least 10 meters without rest. Unilateral walking aids are allowed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patient from inpatient or outpatient rehabilitation centers.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Other neurologic conditions.
- Orthopedic conditions that influence gait.
- Visual impairments that impede independent walking.
- Cerebellar stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual observation of arm swing during walkingThe 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. | Other | Stroke group |
Primary outcome
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.
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.
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.
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)
10 secondary outcomes
Demographic variables
Time frame: Single point of assessment at assessment day 1
Fugl Meyer assessment upper limb section
Time frame: Single point of assessment at assessment day 1
Fugl Meyer assessment lower limb section
Time frame: Single point of assessment at assessment day 1
Upper limb spasticity (Modified Ashworth Scale)
Time frame: 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
Sensory assessment of the upper limb
Time frame: Single point of assessment at assessment day 1
Shoulder subluxation (palpation)
Time frame: Single point of assessment at assessment day 1
Trunk control
Time frame: Single point of assessment at assessment day 1
Upper limb pain during walking
Time frame: Single point of assessment at assessment day 1
Gait speed
Time frame: Single point of assessment at assessment day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gait, Hemiplegic and Stroke, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interrater reliability of the upper limb observation scale (time frame: Single point of assessment within one week after the 2D video has been made). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.