Gait Adaptability Training, Using Augmented Reality, for Individuals in the Chronic Phase After Stroke
- Conditions
- Stroke
- Interventions
- Behavioral: Gait adaptability training
- Registration Number
- NCT05827380
- Lead Sponsor
- Sint Maartenskliniek
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- > 6 months after first unilateral supratentorial stroke (chronic phase)
- Able to walk at least 10 minutes independently
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Training group Gait adaptability training 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
- Primary Outcome Measures
Name Time Method Walking Adaptability Ladder Test (WALT) score Within 1 week post-intervention 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.
Emory Functional Ambulation Profile (EFAP) score Within 1 week post-intervention 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.
- Secondary Outcome Measures
Name Time Method Balance performance Within 1 week post-intervention 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).
Balance confidence Within 1 week post-intervention Evaluating balance confidence using the Activity Balance Scale, measured on a 0% - 100% scale, where a higher score is a better outcome
Daily life gait performance as assessed by gait quality Within 1 week post-intervention Measured by inertial measurement units placed on both feet and the lower back. Analysis through cusomized algorythms.
Daily life walking activity assessed by walking time per day Within 1 week post-intervention Average time of walking during the day (minutes) measured in one week using the Activ8.
Balance performance through MiniBESTest Within 1 week post-intervention 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.
Lab-based walking adaptability test Within 1 week post-intervention 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.
Walking performance Within 1 week post-intervention Measure of walking ability using the 10meter walktest, measured in seconds where a lower score is a better outcome
Health-related quality of life Within 1 week post-intervention 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
Trial Locations
- Locations (1)
Sint Maartenskliniek
🇳🇱Ubbergen, Netherlands