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

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.

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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Gait adaptability training

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marijne Nieuwelink, MSc; Phone Number: 024-3272731; Email: m.nieuwelink@maartenskliniek.nl

Study Locations

• Netherlands
  • Ubbergen, Netherlands, 6574NA
    • Recruiting
    • Sint Maartenskliniek
    • Contact: Marijne Nieuwelink, MSc; Phone Number: 024-3272731; Email: m.nieuwelink@maartenskliniek.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training group; Patients 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	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.
No Intervention: Waitlist control group; Patients 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Sint Maartenskliniek
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Vivian Weerdesteyn, Prof. dr., Sint Maartenskliniek

Publications and helpful links

General 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.
• 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.

Helpful 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).

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NL80178.091.21 / 0996

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No