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

Stroke Clinical Trial

— ATTAINS  

Official title:

Adaptability Training for Individuals After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05827380
• Other study ID #: NL80178.091.21 / 0996
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2023
• Source: Sint Maartenskliniek
• Contact: Marijne Nieuwelink, MSc
• Phone: 024-3272731
• Email: m.nieuwelink[@]maartenskliniek.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 6 months after first unilateral supratentorial stroke (chronic phase)

• Able to walk at least 10 minutes independently

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Gait adaptability training
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.

Locations

Country	Name	City	State
Netherlands	Sint Maartenskliniek	Ubbergen

Sponsors (2)

Lead Sponsor	Collaborator
Sint Maartenskliniek	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 1 week post-intervention
Primary	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.	Within 1 week post-intervention
Secondary	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.	Within 1 week post-intervention
Secondary	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).	Within 1 week post-intervention
Secondary	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.	Within 1 week post-intervention
Secondary	Walking performance	Measure of walking ability using the 10meter walktest, measured in seconds where a lower score is a better outcome	Within 1 week post-intervention
Secondary	Balance confidence	Evaluating balance confidence using the Activity Balance Scale, measured on a 0% - 100% scale, where a higher score is a better outcome	Within 1 week post-intervention
Secondary	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.	Within 1 week post-intervention
Secondary	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.	Within 1 week post-intervention
Secondary	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	Within 1 week post-intervention

External Links

•   The English description of the project on the website of the Sint Maartenskliniek.
•   The project description on the website of the Sint Maartenskliniek (where the study will be performed).