Stroke at the chronic stage
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • 18 to 98 years of age • Patients after an ischaemic or haemorraghic stroke at least 6 months prior to the start of the study • Limited ROM in the upper ankle joint dorsiflexion on the hemiparetic side: maximum 0° active ROM (aROM); maximum 5° of passive ROM (pROM) • Capability to independently transfer from a seating to a standing position without an assistive device while the use of the hands is allowed • Capability to independently walk without an assistive device for at least 10 metres • Confirmation of the principle investigator (PI) of the study (clinician) that there are no contraindications as to the exposure to an active training • Voluntary written informed consent
Exclusion criteria
Exclusion criteria: • Any contraindication to manual therapy (ankle instability, ankle inflammation or traumas etc.) • Any not fully recovered injuries of the musculoskeletal system • Previous surgery in the lower extremity region leading to walking impairment due to orthopaedic reasons • Relevant ROM reduction of the hip or knee joints • Any cognitive or communication impairment hindering participation in this pilot study according to the study PI (dementia, severe aphasia, being under legal guardianship etc.) • Diabetes mellitus • Rheumatic diseases • Chronic pain treated by drug therapy • History of previous stroke with persistent, impairing neurological symptoms (as defined by a Modified Rankin Scale score (mRS) of = 3) • Comorbidity hindering participation in this pilot study, according to the study PI (life expectancy <12 months, cancer, severe heart insufficiency etc.) • Modified Rankin Scale (mRS) score = 4 • Pregnancy • Military service
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mini BESTest: Assessment for evaluating dynamic balance | — |
Secondary
| Measure | Time frame |
|---|---|
| Walking speed: 10-Metre Walk Test at maximum speed (10MWT) Mobility: Timed Up and Go test at maximum speed (TUGmax) Dual tasking mobility: Timed Up and Go at maximum speed and dual tasking (TUGmax+cog) Range of motion (ROM, in degrees): Active and passive dorsiflexion and plantarflexion ROM of both upper ankle joints, ankles unloaded, in supine position Active dorsiflexion ROM of both upper ankle joints, ankles loaded, standing position Impairment and health-related quality of life limitations after a stroke: SIS v2.0 - Stroke Impact Scale & Stroke Toolbox (SIS) Feasibility parameters: - A target recruitment rate of 25% of estimated 145 eligible patients or a minimum of 6 participants per month. - A target retention rate of 85% - A minimum target adherence rate of 75% for the home exercises (actual performance of at least 12 out of 16 planned home exercise sessions) Number of falls: both the number of falls during the home exercises and the overall intervention period will be documented in a diary. Participants’ acceptance of the intervention: will be evaluated by a semi-structured qualitative interview with predefined questions. | — |
Countries
Germany
Contacts
Therapiezentrum Kinema