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

Sint Maartenskliniek

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Gait adaptability training

Study type: Interventional

Funder types: Other

Identifiers

NCT05827380

NL80178.091.21 / 0996

Details and patient eligibility

About

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

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Training group

Experimental group

Description:

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

Treatment:

Behavioral: Gait adaptability training

Waitlist control group

No Intervention group

Description:

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.