Stroke
Conditions
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
Interventions
BEHAVIORALGait 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.
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Sint Maartenskliniek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
| 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. |
| 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). |
Countries
Netherlands
Contacts
Primary ContactMarijne Nieuwelink, MSc
Outcome results
None listed