stroke patients with pusher symptoms
Conditions
Interventions
Group 1: Gait training with asymmetrical belt suspension
Group 2: gait training with symmetrical belt suspension
Sponsors
Kliniken Beelitz GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of stroke (ischemic or hemorrhagic) - Early subacute phase (7 - 90 days after stroke) - Walking ability: FAC 0-2 - hemodynamically stable - Sufficient understanding of the task and informed consent of the patient - SCP > 0 in all sections
Exclusion criteria
Exclusion criteria: All contraindications due to the manufacturer (see instructions for use Thera-Trainer Lyra 2017): - Body weight >150kg - Height under 100 or over 195 cm - Osseous instability (non-consolidable fractures, unstable spine, severe osteoporosis) - Highly pronounced fixed contractures - Open skin lesions in the trunk area - Unstable vital functions (e.g. circulatory and pulmonary function, mechanical ventilation) - Severe cognitive impairment or severe communication disorders - Severe vascular impairment of the lower extremities - Patients with prescribed bed rest, immobilization or isolation - Hip, knee and ankle arthrodesis - Acute inflammatory joint effusion (knee, hip, elbow, shoulder) with swelling, redness, overheating - recent implants, e.g. hip endoprostheses less than six months ago Other: - incompliance - Participation in further intervention studies - Withdrawal of informed consent (discontinuation by patient) - Practical reasons (e.g. lack of compliance) - Negative side effects during or after gait training or during other tests - Occurrence of serious events that make discontinuation necessary - Subsequent occurrence of an exclusion criterion - For medical reasons - Decision of the study management in case of unacceptable risks under risk-benefit assessment - Occurrence of other serious events that make discontinuation necessary - On the advice of the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scale for Contraversive Pushing (SCP): Number of sessions to achieve an improvement of 1.39 points on SCP 1.39 points ? MDC (Cuenca Zaldivar et al., 2022) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pre-post changes for: a) Walking ability - Functional Ambulation Categories (FAC) b) Pushing symptoms - Scale for Contraversive Pushing (SCP) c) Balance - Gleichgewicht: Berg – Balance – Scale (BBS) - Modified Functional Reach Test d) Everyday skills (external assessements) - Barthel Index (assessment of general everyday independence and need for care) Training parameters - Gait speed (km/h), body weight support (in % of body weight) and gait duration (in min) - Subjective perceived stress level measured using the Borg scale (for each training session) In order to characterize the study sample sample the following data is assessed: - Socio-demographic data (age, education, gender) Biomechanical investigation of straight an inclined belt suspension by calculating and measuring the weight distribution | — |
Countries
Germany
Contacts
Public ContactAnna Gorsler
Kliniken Beelitz GmbH
Outcome results
None listed