I63
Conditions
Interventions
Group 1: Study participants undergo a robot-assisted gait therapy using an end-effector-based gait trainer. Each therapy session lasts 60 minutes and is conducted twice weekly over a period of three w
Sponsors
Schön Klinik München Schwabing
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: * Diagnosed stroke according to ICD-10-GM: * I63: Cerebral infarction (ischemic stroke) * I61: Intracerebral hemorrhage (hemorrhagic stroke) * I64: Stroke, not specified as hemorrhage or infarction * Subacute phase of stroke rehabilitation (between 6 weeks and 6 months after the event) * Functional Ambulation Categories (FAC) 0–2: * FAC 0: no ambulation possible * FAC 1: ambulation possible with maximal assistance * FAC 2: ambulation possible with minimal assistance * Minimum age: 18 years * Presence of at least one of the following target criteria: * Spasticity * Joint contracture * Foot deformity * Impaired knee control * Cognitive impairment * Written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Exclusion Criteria: * Orthopedic comorbidities with relevant gait impairment (e.g., skeletal instability, severe osteoarthritis, inflammatory conditions) * Cardiovascular contraindications according to device manufacturer guidelines * Dermatological limitations (e.g., open skin lesions at contact points, pressure ulcers, decubitus) * Body weight exceeding 150 kg * Body height below 1.40 m or above 2.00 m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Research Objective:?To identify patient-specific factors influencing the suitability for end-effector-based gait training, a univariate analysis will be conducted. The outcome variable is defined as a binary classification of participants into either “suitable” or “not suitable” for robot-assisted gait therapy. This classification is applied retrospectively based on the following criteria: Suitability ("suitable") is defined as follows: * Completion of =5 therapy sessions, each lasting at least 20 minutes; * An average of =400 steps per session (the target range for effective motor learning is 800–1000 steps per session, as described by Mehrholz et al., 2020; a pragmatic threshold was selected to identify potentially eligible participants); * No therapy discontinuation (e.g., due to pain exceeding NRS >6); * No fundamental limitations in adapting the device to the individual anatomical and mechanical requirements of the participant. Group differences will be analyzed using t-tests for normally distributed continuous variables or Mann–Whitney U-tests for non-normally distributed continuous variables. Categorical variables will be analyzed using the chi-square test. To derive potential threshold values for standardized clinical decision-making, a receiver operating characteristic (ROC) curve analysis will be performed for continuous variables. This approach will allow the determination of optimal cut-off values to distinguish between suitable and non-suitable participants. Additionally, 95% confidence intervals will be calculated for key parameters to estimate the variability within the study sample. A multivariate logistic regression analysis will be deliberately omitted in this pilot study, as the planned sample size of 25 participants is insufficient for producing stable estimates within a multivariate model. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Research Questions:?The secondary research questions aim to explore the influence of specific factors on therapy suitability and implementation. * Spasticity and Therapy Suitability:?The association between spasticity—assessed using the Modified Tardieu Scale—and suitability for end-effector-based gait training will be analyzed using the Mann–Whitney U test. To identify potential threshold values, a receiver operating characteristic (ROC) curve analysis will be performed. Additionally, a Spearman correlationwill be used to examine the relationship between the degree of spasticity and functional gait parameters. * Joint Contractures and Foot Deformities:?The impact of joint contractures and foot deformities on the adaptability of the gait training device will be investigated using descriptive analysis. Furthermore, gait parameters recorded during the robotic training sessions (e.g., gait speed, gait endurance) will be used to assess functional implications. Relationships between the extent of structural impairments and gait parameters will be explored using Spearman correlations, accounting for potential non-linear associations and the small sample size. * Cognitive Impairments and Therapy Adherence:?The relationship between cognitive performance—measured via the Mini-Mental State Examination (MMSE)—and successful completion of the gait training intervention will be analyzed using ordinal logistic regression. * Pain Intensity and Therapy Acceptance:?Pain intensity—measured using the Numeric Rating Scale (NRS)—will be analyzed for its association with gait parameters and therapy adherence. Mann–Whitney U tests will be used for group comparisons, and Spearman correlation analyses will be conducted to explore continuous associations. | — |
Countries
Germany
Contacts
Public ContactLya-Sophia Beer
Schön Klinik München Schwabing
Outcome results
None listed