StrokeNCT04180124
Movement Analysis of Stroke Patients When Walking on a Treadmill
A study testing Walking in people with Stroke, run by University Ghent at 1 site in Belgium.
Trial summary
In daily clinic, the use of treadmills to analyze the gait quality of a patient increases. The advantages of using a treadmill are that a smaller space is needed compared to a 3D lab for motion analysis, more steps can be recorded in shorter time period and patients should not start, stop or rotate during the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Jan 2020to 15 Sep 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke patients with the ability to walk without walking devices for 6 minutes without rest (indoor walking). Use of AFO is allowed if necessary.
Who cannot join
- Traumatic brain lesions (car accident, fall with bike, …)
- Other disorders such as neurologic, musculoskeletal, respiratory or severe cardiovascular disorders that affected gait performance
- Bilateral stroke
- Cerebellar stroke
- Orthopedic surgery lower limbs in the past
- Cognitive or language impairments that prevent the patients from understand simple orders
Trial locations and contacts
1 site in 1 country.
About this study
In daily clinic, the use of treadmills to analyze the gait quality of a patient increases. The advantages of using a treadmill are that a smaller space is needed compared to a 3D lab for motion analysis, more steps can be recorded in shorter time period and patients should not start, stop or rotate during the analyses. One of the systems which can be used to perform motion analysis on a treadmill is the GRAIL. This GRAIL (Gait Real-time Analysis Interactive Lab) consists of an advanced treadmill with force sensors. Patients can walk on this treadmill with an imposed speed (fixed-speed) or at a speed determined by the patient itself (self-paced). Because not everyone is used to walk on a treadmill it is important to know if a person's walking pattern is different when he walks over ground compared to walking on the treadmill. Based on these insights, decisions can be made regarding interventions including treadmill training or this findings can be taking into account during further analysis of walking patterns on a treadmill. For this study stroke patients would be invited for an assessment on the treadmill (1 assessment moment). The movement pattern of these patients would be compared in different conditions:
- (Forward and backward) Walking at comfortable walking speed on the GAITRite
- Walking at comfortable walking speed on the treadmill in fixed speed mode
- Walking at comfortable walking speed +0.2 m/s (faster walking) on the treadmill in fixed speed mode
- Walking at comfortable walking speed on the treadmill in self-paced mode
- Backward walking at comfortable walking speed on the treadmill in fixed speed mode (only if patients are eligible to do so)
Read more
Hypotheses based on this study protocol:
- Do stroke patients walk different over ground compared to treadmill walking
- Do stroke patients walk different during treadmill walking self-paced compared to fixed speed
- Do stroke patients walk different during treadmill walking fixed speed comfortable walking speed compared to fast walking
- Is there a correlation between upper extremity impairment and arm swing
- Conditions
- Stroke
- Being tested
- Walking
- Keywords
- Gait pattern, Treadmill walking, Arm swing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingOther
Patients walk over ground on a mat with sensors and on a treadmill with sensors (in different conditions) to compare their movement pattern.
Also the movement pattern will be compared between walking at comfortable walking speed en fast walking.
Finally, the correlation between upper extremity impairment and arm swing will be investigated.
| Study group | Role | What they receive |
|---|---|---|
| GaitRite | Experimental | Patients will walk on the GaitRite.
* forward walking at comfortable gait speed (6 x 10 meter)
* backward walking at comfortable gait speed (4 x 10 meter) Receives: Other: Walking |
| Treadmill walking self-paced | Experimental | Patients will walk on the treadmill in self-paced mode. They can control walking speed by themselves.
Patient walks for 3 minutes for every condition = data will be recorded for 1 minute. Receives: Other: Walking |
| Treadmill walking fixed speed - comfortable speed | Experimental | Patients will walk on the treadmill in fixed speed mode. They will walk at comfortable gait speed, which is determined in the familiarization period.
Patient walks for 3 minutes for every condition = data will be recorded for 1 minute. Receives: Other: Walking |
| Treadmill walking fixed speed - fast speed | Experimental | Patients will walk on the treadmill in fixed speed mode. They will walk at a gait speed, which is 1 minimal clinical difference faster than their comfortable gait speed.
Patient walks for 3 minutes for every condition = data will be recorded for 1 minute. Receives: Other: Walking |
| Treadmill walking fixed speed - backward walking | Experimental | Patients will walk on the treadmill in fixed speed mode. Patient will walk backwards on the treadmill if they are able to.
Patient walks for 3 minutes for every condition = data will be recorded for 1 minute. Receives: Other: Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in kinematics
Change in full body 3D kinematic analyses during walking (°)
Measured: Single point of assessment in one day
Change in kinetics
Change in full body 3D kinetic analyses during walking
Measured: Single point of assessment in one day
Secondary outcomes (5)
Speed variability during self-paced treadmill walking
Average walking speed (and standard deviation) during self-paced treadmill walking
Measured: Single point of assessment in one day
Postural stability test
Balance test
Measured: Baseline assessment before walking trials
Fugl Meyer assessment UL
Impairment test for upper extremity in stroke patients: Fugl Meyer assessment - score between 0 and 66. Higher score reflects less impairment of the upper limb.
Measured: Baseline assessment before walking trials
Fugl Meyer assessment LL
Impairment test for lower extremity in stroke patients: Fugl Meyer assessment lower extremity. Scores between 0 - 34. Higher score reflects less impairment of the lower limb.
Measured: Baseline assessment before walking trials
Lateral rotation of the scapula
Lateral rotation of the scapula measured with an inclinometer (°)
Measured: Baseline assessment before walking trials
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start6 Jan 2020
- Primary completion15 Sep 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180124
- Sponsor's protocol ID
- 2019-1349
- Status last verified
- Jan 2020
- First submitted
- 21 Oct 2019
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Analysis of Stroke Patients When Walking on a Treadmill
- ClinicalTrials.gov ID
- NCT04180124
- Acronym / sponsor ID
- 2019-1349
- Conditions
- Stroke
- Keywords
- Gait pattern, Treadmill walking, Arm swing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- University Hospital, Ghent
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 27 Nov 2019 (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.
In daily clinic, the use of treadmills to analyze the gait quality of a patient increases. The advantages of using a treadmill are that a smaller space is needed compared to a 3D lab for motion analysis, more steps can be recorded in shorter time period and patients should not start, stop or rotate during the analyses. One of the systems which can be used to perform motion analysis on a treadmill is the GRAIL. This GRAIL (Gait Real-time Analysis Interactive Lab) consists of an advanced treadmill with force sensors. Patients can walk on this treadmill with an imposed speed (fixed-speed) or at a speed determined by the patient itself (self-paced). Because not everyone is used to walk on a treadmill it is important to know if a person's walking pattern is different when he walks over ground compared to walking on the treadmill. Based on these insights, decisions can be made regarding interventions including treadmill training or this findings can be taking into account during further analysis of walking patterns on a treadmill. For this study stroke patients would be invited for an assessment on the treadmill (1 assessment moment). The movement pattern of these patients would be compared in different conditions:
- (Forward and backward) Walking at comfortable walking speed on the GAITRite
- Walking at comfortable walking speed on the treadmill in fixed speed mode
- Walking at comfortable walking speed +0.2 m/s (faster walking) on the treadmill in fixed speed mode
- Walking at comfortable walking speed on the treadmill in self-paced mode
- Backward walking at comfortable walking speed on the treadmill in fixed speed mode (only if patients are eligible to do so)
Hypotheses based on this study protocol:
- Do stroke patients walk different over ground compared to treadmill walking
- Do stroke patients walk different during treadmill walking self-paced compared to fixed speed
- Do stroke patients walk different during treadmill walking fixed speed comfortable walking speed compared to fast walking
- Is there a correlation between upper extremity impairment and arm swing
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GaitRite | Experimental | Other: WalkingPatients will walk on the GaitRite. * forward walking at comfortable gait speed (6 x 10 meter) * backward walking at comfortable gait speed (4 x 10 meter) |
| Treadmill walking self-paced | Experimental | Other: WalkingPatients will walk on the treadmill in self-paced mode. They can control walking speed by themselves. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute. |
| Treadmill walking fixed speed - comfortable speed | Experimental | Other: WalkingPatients will walk on the treadmill in fixed speed mode. They will walk at comfortable gait speed, which is determined in the familiarization period. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute. |
| Treadmill walking fixed speed - fast speed | Experimental | Other: WalkingPatients will walk on the treadmill in fixed speed mode. They will walk at a gait speed, which is 1 minimal clinical difference faster than their comfortable gait speed. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute. |
| Treadmill walking fixed speed - backward walking | Experimental | Other: WalkingPatients will walk on the treadmill in fixed speed mode. Patient will walk backwards on the treadmill if they are able to. Patient walks for 3 minutes for every condition = data will be recorded for 1 minute. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stroke patients with the ability to walk without walking devices for 6 minutes without rest (indoor walking). Use of AFO is allowed if necessary.
Key exclusion criteria (6 listed)
- Traumatic brain lesions (car accident, fall with bike, …)
- Other disorders such as neurologic, musculoskeletal, respiratory or severe cardiovascular disorders that affected gait performance
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 |
|---|---|---|
| WalkingPatients walk over ground on a mat with sensors and on a treadmill with sensors (in different conditions) to compare their movement pattern. Also the movement pattern will be compared between walking at comfortable walking speed en fast walking. Finally, the correlation between upper extremity impairment and arm swing will be investigated. | Other | GaitRite, Treadmill walking fixed speed - backward walking, Treadmill walking fixed speed - comfortable speed, Treadmill walking fixed speed - fast speed, Treadmill walking self-paced |
Primary outcome
Change in kinematics
Time frame: Single point of assessment in one day
Change in full body 3D kinematic analyses during walking (°)
Change in kinetics
Time frame: Single point of assessment in one day
Change in full body 3D kinetic analyses during walking
5 secondary outcomes
Speed variability during self-paced treadmill walking
Time frame: Single point of assessment in one day
Postural stability test
Time frame: Baseline assessment before walking trials
Fugl Meyer assessment UL
Time frame: Baseline assessment before walking trials
Fugl Meyer assessment LL
Time frame: Baseline assessment before walking trials
Lateral rotation of the scapula
Time frame: Baseline assessment before walking trials
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 8 Apr 2021.
- Individual participant dataSharing planned: No
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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?
A study testing Walking in people with Stroke, run by University 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 1 inclusion and 6 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 8 Apr 2021. 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?
Change in kinematics (time frame: Single point of assessment in one day). The study lists 2 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 8 Apr 2021.