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StrokeATTAINSNCT05827380

Gait Adaptability Training, Using Augmented Reality, for Individuals in the Chronic Phase After Stroke

A study testing Gait adaptability training in people with Stroke, run by Sint Maartenskliniek at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: The majority of stroke survivors regain walking ability, however the ability to adapt their gait to meet environmental demands remains impaired. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteNetherlands
Study dates
22 Sep 2022to Dec 2024
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

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.
  • Has received multiple training sessions on C-Mill or GRAIL in the past 12 months
  • 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.

Marijne Nieuwelink, MSc contact

024-3272731

m.nieuwelink@maartenskliniek.nl

Netherlands1 site, 1 recruiting

  • Sint Maartenskliniek

    Ubbergen, 6574NA

    Marijne Nieuwelink, MSc, 024-3272731, m.nieuwelink@maartenskliniek.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Adaptability Training for Individuals After Stroke

Background: The majority of stroke survivors regain walking ability, however the ability to adapt their gait to meet environmental demands remains impaired. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. Treatment targeting these gait deficiencies is, therefore, critical for allowing safe and independent community ambulation in people with stroke. Rehabilitation programs targeting gait adaptability have gained interest in clinical practice. Besides, the use of augmented and virtual reality in rehabilitation programs becomes more common. Concerning gait adaptability, training programs are developed using the Cmill, an instrumented treadmill with augmented reality. Even though the efficacy of these interventions is limited to small, pilot trials, results are promising. Based on these results we hypothesize that a gait training program using the Cmill will improve gait adaptability and daily-life gait performance in people in the chronic phase after stroke.

Objective: The primary objective of this study is to evaluate the efficacy of a gait training program using an instrumented treadmill with virtual and augmented reality for improving gait adaptability in people in the chronic phase after stroke. A second objective is to identify patient characteristics that predict a more favorable response to training.

Read more

Study design: Randomized, waiting-list controlled trial to evaluate gait adaptability training

Study population: 84 stroke patients in the chronic phase after stroke

Conditions
Stroke
Being tested
Gait adaptability 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

    During a period of approximately 5 weeks participants will receive 10 one hour training sessions aimed at improving gait adaptability, 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 offered.

Study groups in NCT05827380
Study groupRoleWhat they receive
Training groupExperimentalPatients assigned to the training group will receive a training targeting on gait adaptability using the C-mill. Subjects are asked to stop any other physical therapy program targeting gait, balance or leg function during the training period. Assessments will take place pre- and post-intervention
Receives: Behavioral: Gait adaptability training
Waitlist control groupNo interventionPatients assigned to the waitlist control group will receive standard care for 5 weeks whereafter they will receive the same training as the training group. Assessments will take place pre-intervention, post-waiting period and post-intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Within 1 week post-intervention

  2. 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: Within 1 week post-intervention

Secondary outcomes (8)

  1. 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: Within 1 week post-intervention

  2. 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: Within 1 week post-intervention

  3. Balance performance through MiniBESTest

    Measure of balance and gait stability using the Mini Balance Evaluation Systems Test (MiniBESTes). Tasks are scored on a 3-point scale. Outcome is an average score ranging between 0 and 1 where a higher score is a better outcome.

    Measured: Within 1 week post-intervention

  4. Walking performance

    Measure of walking ability using the 10meter walktest, measured in seconds where a lower score is a better outcome

    Measured: Within 1 week post-intervention

  5. 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: Within 1 week post-intervention

  6. 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: Within 1 week post-intervention

  7. 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: Within 1 week post-intervention

  8. 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: Within 1 week post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start22 Sep 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05827380
Sponsor's protocol ID
NL80178.091.21 / 0996
Acronym
ATTAINS
Status last verified
Apr 2023
First submitted
7 Feb 2023
Last updated
25 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 32776854

  • Tuijtelaars 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

  • Nieuwelink M, Smulders K, Kamphuis J, Nonnekes J, Keijsers N, Weerdesteyn V. Walking adaptability training for individuals after stroke (ATTAINS): study protocol for a randomized, waiting-list controlled trial. Trials. 2025 Nov 27;26(1):595. doi: 10.1186/s13063-025-09276-w.

    PubMed 41310779

Questions about this trial

What is this clinical trial studying?

A study testing Gait adaptability 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 2 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: status not confirmed, as of the sponsor's last update on 25 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: Within 1 week post-intervention). 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 NCT05827380, which also lists 3 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 25 Apr 2023.

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ATTAINS Clinical Trial NCT05827380 | AzTrials