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

NCT05827380 | Unknown

• 1 other identifier: NL80178.091.21 / 0996
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Lab-based walking adaptability test

  Within 1 week post-intervention

• Balance performance

  Within 1 week post-intervention

• Balance performance through MiniBESTest

  Within 1 week post-intervention

• Walking performance

  Within 1 week post-intervention

• Balance confidence

  Within 1 week post-intervention

Study Arms (2)

Training group

EXPERIMENTAL

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

Waitlist control group

NO INTERVENTION

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.

Interventions

Gait adaptability training BEHAVIORAL

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.

Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 6 months after first unilateral supratentorial stroke (chronic phase)
• Able to walk at least 10 minutes independently

You may not qualify if:

• 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

Sponsors & Collaborators

• Sint Maartenskliniek: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Sint Maartenskliniek

Ubbergen, 6574NA, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 32776854 BACKGROUND

• 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.

  PMID: 33915437 BACKGROUND

• 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.

  PMID: 41310779 DERIVED

Related Links

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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vivian Weerdesteyn, Prof. dr.

  Sint Maartenskliniek

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marijne Nieuwelink, MSc

CONTACT

024-3272731; m.nieuwelink@maartenskliniek.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: April 25, 2023
• Study Start: September 22, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

NL (1)