StrokeATTAINSNCT05825053
Retaining Short-term Training Effects on Gait Adaptability in People With Stroke
A study testing Gait adaptability training and Home-based exercise training in people with Stroke, run by Sint Maartenskliniek at 1 site in Netherlands.
Trial summary
Background: The majority of stroke survivors regain walking ability. However, the ability to adapt gait patterns to meet environmental demands remains impaired in a majority of people in the chronic phase after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Gait adaptability training and Home-based exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2023to Dec 2025
- 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
- > 6 months after first unilateral supratentorial stroke (chronic phase)
- Able to walk at least 10 minutes independently
- Initial involvement of the lower extremity after stroke.
- Having completed (minimal 8/10 training sessions) the 5 week gait adaptability training program using the C-Mill
Who cannot join
- Any other neurological or musculoskeletal disease affecting gait or balance (e.g. Parkinson's disease, knee osteoarthritis)
- Contractures or spasticity requiring other treatment (e.g. botulinum toxin treatment) within the duration of the training period.
- Severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Single Booster Sessions or Home-based Exercise Program for Individuals in the Chronic Phase After Stroke to Retain Short-term Training Effects on Gait Adaptability, a Study-protocol.
Background: The majority of stroke survivors regain walking ability. However, the ability to adapt gait patterns to meet environmental demands remains impaired in a majority of people in the chronic phase after stroke. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. Treatment targeting gait adaptability is therefore critical for safe and independent community ambulation in people with stroke. Augmented or virtual reality in rehabilitation programs can be used to train gait adaptability in a controlled situation. A few studies have evaluated gait adaptability training in people with stroke. Although results were promising, these studies did not include an adaptability-related outcome measure, or were limited to uncontrolled or small-scaled pilot studies. Moreover, it is unknown if beneficial training effects can be fostered for 1 year after completion of a training program. We evaluate the short-term effects of a 5-week gait adaptability training in an adequately powered, waiting-list controlled clinical trial [ref naar clin trial nummer]. In the current study, we focus on the retention of potentially beneficial effects of this 5 week gait adaptability training program. We will evaluate if short-term effects of gait adaptability training can be retained through single training sessions to boost performance, or by an home exercise program. We hypothesize that booster sessions and home-based exercise will both yield better retention of training effects at 1 year follow-up as compared to the control arm without an experimental intervention.
Objective: The primary objective of this study is to test the hypothesis that retention of training-induced gains in gait adaptability can be fostered by providing booster sessions or by prescribing home-based training.
Read more
Study design: Explorative randomized study, comparing the effect of 3 1-hr booster training sessions against home-based exercise against no intervention on gait adaptability performance 1 year after completion of a 5-week gait adaptability training program.
Study population: Stroke patients in the chronic phase after stroke, who completed the 5-week gait adaptability training using the C-Mill and agreed to continue in this follow-up study. We expect this to be 50-75 participants.
- Conditions
- Stroke
- Being tested
- Gait adaptability training, Home-based exercise training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait adaptability trainingBehavioural
Over a span of 1 year participants will receive 3 one hour, single sessions at 3, 6 and 9 months following baseline assessment, of gait adaptability training, using the C-mill (an instrumented treadmill with augmented reality). Several aspects of gait adaptability, such as obstacle avoidance, accelerating/decelerating and precision stepping, will be trained.
Home-based exercise trainingBehavioural
Participants will receive tailored exercise through an online platform targeting gait adaptability. Participants are instructed to train at a minimum of 60 minutes per week, with a frequency of 2 sessions per week. Participants will be supported through tele-consultations on a monthly basis for the first 3 months and bi-monthly for the remaining time of the study. These consultations are focused on technical support, on ways to ensure training progression and to encourage adherence to the program.
| Study group | Role | What they receive |
|---|---|---|
| Booster group | Experimental | Participants assigned to the booster group will receive a three single training sessions 3 months apart targeting gait adaptability using the C-mill. Assessments will take place after giving informed consent which is indicated as the start of the study (baseline), 6 months and 12 months post-baseline. Receives: Behavioral: Gait adaptability training |
| Home-based exercise group | Experimental | Participants assigned to the home-based exercise group will receive a program for training at home aiming at a minimum training time of 60 minutes per week. Assessments will take place after giving informed consent which is indicated as the start of the study (baseline), 6 months and 12 months post-baseline Receives: Behavioral: Home-based exercise training |
| Control group | No intervention | Participants assigned to the control group will not follow any additional intervention other than the standard care they already receive for the year following the completion of the 5-week gait adaptability training using the C-Mill from the ATTAINS study. Assessments will take place after giving informed consent which is indicated as the start of the study(baseline), 6 months and 12 months post-baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Adaptability Ladder Test (WALT) score
Measure of gait adaptability. An adapted version for adults of the Walking Adaptability Laddertest for Kids (WAL-K) to assess the ability to flexibly adjust the gait pattern during overground walking. Outcome is based on performance time and foot placement errors measured in seconds where a lower score is a better outcome.
Measured: 12 months post-baseline
Emory Functional Ambulation Profile (EFAP) score
Measure of gait adaptability. In this task the participants traverse a standardized 5m obstacle course. Outcome is time to perform the task measured in seconds where a lower score is a better outcome
Measured: 12 months post-baseline
Secondary outcomes (8)
Lab-based walking adaptability test
Measure of gait adaptability. Target stepping task using the Gait Real-time Analysis Interactive Lab (GRAIL) where participant must step on projected stepping stones as accurately as possible. Step width and step length between the stepping stones will vary.
Measured: 12 months post-baseline
Balance performance
Measure of gait stability, measured by the margin of stability (meter) and the center of mass excursion (meter), on treadmill walking with perturbations using the Gait Real-time Analysis Interactive Lab (GRAIL).
Measured: 12 months post-baseline
Walking performance
Measure of walking ability using the 10meter walktest, measured in seconds where a lower score is a better outcome.
Measured: 12 months post-baseline
Balance confidence
Evaluating balance confidence using the Activity Balance Scale, measured on a 0% - 100% scale, where a higher score is a better outcome.
Measured: 12 months post-baseline
Daily life gait performance as assessed by gait quality
Measured by inertial measurement units placed on both feet and the lower back. Analysis through cusomized algorythms.
Measured: 12 months post-baseline
Daily life walking activity assessed by walking time per day
Average time of walking during the day (minutes) measured in one week using the Activ8.
Measured: 12 months post-baseline
Health-related quality of life
Evaluating the disability and health-related quality of life after stroke using the Stroke Impact Scale mobility subscale, measure on a 5-point scale ("could not do at all = 1" - "not difficult at all = 5") where a higher score is a better outcome.
Measured: 12 months post-baseline
Balance performance through MiniBESTest
Measure of balance and gait stability using the Mini Balance Evaluation Systems Test (MiniBESTes). Tasks are score on a 3-point scale. Outcome is an average score ranging between 0 and 1 where a higher score is a better outcome.
Measured: 12 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- Vivian Weerdesteyn, Prof. dr., Principal investigator, Sint Maartenskliniek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825053
- Sponsor's protocol ID
- NL80178.091.21 / 0996_2
- Acronym
- ATTAINS
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuijpers R, Smulders E, Groen BE, Smits-Engelsman BCM, Nijhuis-Van der Sanden MWG, Weerdesteyn V. Reliability and construct validity of the Walking Adaptability Ladder Test for Kids (WAL-K): a new clinical test for measuring walking adaptability in children. Disabil Rehabil. 2022 Apr;44(8):1489-1497. doi: 10.1080/09638288.2020.1802523. Epub 2020 Aug 10.
PubMed 32776854Tuijtelaars J, Roerdink M, Raijmakers B, Nollet F, Brehm MA. Polio survivors have poorer walking adaptability than healthy individuals. Gait Posture. 2021 Jun;87:143-148. doi: 10.1016/j.gaitpost.2021.04.031. Epub 2021 Apr 21.
PubMed 33915437
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single Booster Sessions or Home-based Exercise Program for Individuals in the Chronic Phase After Stroke to Retain Short-term Training Effects on Gait Adaptability, a Study-protocol.
- ClinicalTrials.gov ID
- NCT05825053
- Acronym / sponsor ID
- ATTAINS / NL80178.091.21 / 0996_2
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Apr 2023 (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.
Background: The majority of stroke survivors regain walking ability. However, the ability to adapt gait patterns to meet environmental demands remains impaired in a majority of people in the chronic phase after stroke. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. Treatment targeting gait adaptability is therefore critical for safe and independent community ambulation in people with stroke. Augmented or virtual reality in rehabilitation programs can be used to train gait adaptability in a controlled situation. A few studies have evaluated gait adaptability training in people with stroke. Although results were promising, these studies did not include an adaptability-related outcome measure, or were limited to uncontrolled or small-scaled pilot studies. Moreover, it is unknown if beneficial training effects can be fostered for 1 year after completion of a training program. We evaluate the short-term effects of a 5-week gait adaptability training in an adequately powered, waiting-list controlled clinical trial [ref naar clin trial nummer]. In the current study, we focus on the retention of potentially beneficial effects of this 5 week gait adaptability training program. We will evaluate if short-term effects of gait adaptability training can be retained through single training sessions to boost performance, or by an home exercise program. We hypothesize that booster sessions and home-based exercise will both yield better retention of training effects at 1 year follow-up as compared to the control arm without an experimental intervention.
Objective: The primary objective of this study is to test the hypothesis that retention of training-induced gains in gait adaptability can be fostered by providing booster sessions or by prescribing home-based training.
Study design: Explorative randomized study, comparing the effect of 3 1-hr booster training sessions against home-based exercise against no intervention on gait adaptability performance 1 year after completion of a 5-week gait adaptability training program.
Study population: Stroke patients in the chronic phase after stroke, who completed the 5-week gait adaptability training using the C-Mill and agreed to continue in this follow-up study. We expect this to be 50-75 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Booster group | Experimental | Behavioral: Gait adaptability trainingParticipants assigned to the booster group will receive a three single training sessions 3 months apart targeting gait adaptability using the C-mill. Assessments will take place after giving informed consent which is indicated as the start of the study (baseline), 6 months and 12 months post-baseline. |
| Home-based exercise group | Experimental | Behavioral: Home-based exercise trainingParticipants assigned to the home-based exercise group will receive a program for training at home aiming at a minimum training time of 60 minutes per week. Assessments will take place after giving informed consent which is indicated as the start of the study (baseline), 6 months and 12 months post-baseline |
| Control group | No intervention | –Participants assigned to the control group will not follow any additional intervention other than the standard care they already receive for the year following the completion of the 5-week gait adaptability training using the C-Mill from the ATTAINS study. Assessments will take place after giving informed consent which is indicated as the start of the study(baseline), 6 months and 12 months post-baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 6 months after first unilateral supratentorial stroke (chronic phase)
- Able to walk at least 10 minutes independently
- Initial involvement of the lower extremity after stroke.
- Having completed (minimal 8/10 training sessions) the 5 week gait adaptability training program using the C-Mill
Key exclusion criteria (3 listed)
- Any other neurological or musculoskeletal disease affecting gait or balance (e.g. Parkinson's disease, knee osteoarthritis)
- Contractures or spasticity requiring other treatment (e.g. botulinum toxin treatment) within the duration of the training period.
- Severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments
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 |
|---|---|---|
| Gait adaptability trainingOver a span of 1 year participants will receive 3 one hour, single sessions at 3, 6 and 9 months following baseline assessment, of gait adaptability training, using the C-mill (an instrumented treadmill with augmented reality). Several aspects of gait adaptability, such as obstacle avoidance, accelerating/decelerating and precision stepping, will be trained. | Behavioural | Booster group |
| Home-based exercise trainingParticipants will receive tailored exercise through an online platform targeting gait adaptability. Participants are instructed to train at a minimum of 60 minutes per week, with a frequency of 2 sessions per week. Participants will be supported through tele-consultations on a monthly basis for the first 3 months and bi-monthly for the remaining time of the study. These consultations are focused on technical support, on ways to ensure training progression and to encourage adherence to the program. | Behavioural | Home-based exercise group |
Primary outcome
Walking Adaptability Ladder Test (WALT) score
Time frame: 12 months post-baseline
Measure of gait adaptability. An adapted version for adults of the Walking Adaptability Laddertest for Kids (WAL-K) to assess the ability to flexibly adjust the gait pattern during overground walking. Outcome is based on performance time and foot placement errors measured in seconds where a lower score is a better outcome.
Emory Functional Ambulation Profile (EFAP) score
Time frame: 12 months post-baseline
Measure of gait adaptability. In this task the participants traverse a standardized 5m obstacle course. Outcome is time to perform the task measured in seconds where a lower score is a better outcome
8 secondary outcomes
Lab-based walking adaptability test
Time frame: 12 months post-baseline
Balance performance
Time frame: 12 months post-baseline
Walking performance
Time frame: 12 months post-baseline
Balance confidence
Time frame: 12 months post-baseline
Daily life gait performance as assessed by gait quality
Time frame: 12 months post-baseline
Daily life walking activity assessed by walking time per day
Time frame: 12 months post-baseline
Health-related quality of life
Time frame: 12 months post-baseline
Balance performance through MiniBESTest
Time frame: 12 months post-baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Background: PubMed 32776854Kuijpers R, Smulders E, Groen BE, Smits-Engelsman BCM, Nijhuis-Van der Sanden MWG, Weerdesteyn V. Reliability and construct validity of the Walking Adaptability Ladder Test for Kids (WAL-K): a new clinical test for measuring walking adaptability in children. Disabil Rehabil. 2022 Apr;44(8):1489-1497. doi: 10.1080/09638288.2020.1802523. Epub 2020 Aug 10.
- Background: PubMed 33915437Tuijtelaars J, Roerdink M, Raijmakers B, Nollet F, Brehm MA. Polio survivors have poorer walking adaptability than healthy individuals. Gait Posture. 2021 Jun;87:143-148. doi: 10.1016/j.gaitpost.2021.04.031. Epub 2021 Apr 21.
- The English description of the project on the website of the Sint Maartenskliniek.Link provided by the sponsor.
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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.
Vivian Weerdesteyn, Prof. dr. principal investigator
Sint Maartenskliniek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait adaptability training and Home-based exercise training in people with Stroke, run by Sint Maartenskliniek at 1 site in Netherlands.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 24 Apr 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marijne Nieuwelink, MSc (024-3272731, m.nieuwelink@maartenskliniek.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Adaptability Ladder Test (WALT) score (time frame: 12 months post-baseline). 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?
On the ClinicalTrials.gov record for NCT05825053, which also lists 2 linked publications.
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 24 Apr 2023.