Effects of power training on mobility in patients in the subacute phase after stroke

Not Applicable

• Conditions: I60; I61; I62; I63; I64; Subarachnoid haemorrhage; Intracerebral haemorrhage; Other nontraumatic intracranial haemorrhage; Cerebral infarction; Stroke, not specified as haemorrhage or infarction

• Registration Number: DRKS00030187
• Lead Sponsor: andeskrankenhaus Rankweil

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-21
• Study Completion: 2023-10-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Potential study participants must meet all listed inclusion criteria during the inpatient stay at the Landeskrankenhaus in Rankweil to be eligible for participating in this clinical trial. Patients will be included in this clinical trial if they have been diagnosed with a first-ever ischemic or hemorrhagic stroke in the subacute phase (1 week - 26 weeks after stroke) and have a hemiparesis. In addition, patients must be able to walk at least 10 meters with an assistant, have a Functional Ambulation Categories score of 1-2, and are able to achieve a neutral position of the ankle joints. Adult patients aged between 18 and 99 of female, male and diverse genders, of any ethnicity and able to speak and write German will be included. Patients should be able to understand the patient information and study procedures, follow instructions (=24/30 points on the Mini Mental State Examination (MMSE)), and provide written informed consent to participate in the study. Patients will only be included if they appear able to participate in this clinical trial for at least two weeks.

Exclusion Criteria

Exclusion Criteria:
Patients will be excluded from this clinical trial if they meet any of the criteria listed as follows.
• Manifest osteoporosis with previous fractures
• Joint contractures and joint arthrodesis in the lower extremities
• Severe neuropsychological deficits/ severe aphasia/apraxia/pusher syndrome that prevent the implementation of the interventions or the verbal feedback
• Symptomatic/ treatment-requiring inflammations/ infections
• Current joint injury, endoprosthetics and recent fracture in the lower extremities and in the spine in the last 6 months (e.g. knee or hip replacement); Open heart or abdominal cavity surgery in the last 6 months
• Diagnosed and study relevant bone or joint instability of the lower extremity/spine
• Cardiorespiratory insufficiency (New York Heart Association classification II-IV)
• Pregnancy determined by a pregnancy test in women of childbearing potential prior to enrollment in the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Walking speed – assessed by 10-Meter Walk Test (10 MWT)

Secondary Outcome Measures

Name	Time	Method
- Fall risk – assessed by the Timed Up and Go (TUG) and the Modified Functional Reach Test (MFRT) <br>- Fall Rate – assessed by the number of falls during the study intervention period <br>- Ability to walk – assessed by Functional Ambulation Categories (FAC)<br>- Muscle strength – assessed by the Motricity Index (MI) and the 1-Minute Sit-To-Stand Test (1-MSTST)<br>- Fear of falling – assessed by Short Falls Efficacy Scale International (Short FES-I)<br>- Health-related quality of life – assessed by 5-level EQ-5D version (EQ-5D-5L)<br>- Feasibility criteria – assessed by the recruitment rate, retention rate, adherence rate, occurrence of adverse events, acceptability of intervention