Clinical trial NCT05827380: Gait Adaptability Training, Using Augmented Reality, for Individuals in the Chronic Phase After Stroke
Official title: Adaptability Training for Individuals After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-04-25
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Walking Adaptability Ladder Test (WALT) score
timeFrame: Within 1 week post-intervention
measure: Emory Functional Ambulation Profile (EFAP) score
timeFrame: Within 1 week post-intervention
Secondary outcomes:
measure: Lab-based walking adaptability test
timeFrame: Within 1 week post-intervention
measure: Balance performance
timeFrame: Within 1 week post-intervention
measure: Balance performance through MiniBESTest
timeFrame: Within 1 week post-intervention
measure: Walking performance
timeFrame: Within 1 week post-intervention
measure: Balance confidence
timeFrame: Within 1 week post-intervention
measure: Daily life gait performance as assessed by gait quality
timeFrame: Within 1 week post-intervention
measure: Daily life walking activity assessed by walking time per day
timeFrame: Within 1 week post-intervention
measure: Health-related quality of life
timeFrame: Within 1 week post-intervention
Other outcomes:
Locations:
city: Ubbergen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
affiliation: Sint Maartenskliniek
name: Vivian Weerdesteyn, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.