Exploring the effects of a restraining force during gait in persons with post-stroke hemiparesis and able-bodied individuals

Completed

• Conditions: Cerebrovasculair Accident (CVA) & stroke; 10007963

• Registration Number: NL-OMON49478
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Patients:
- A first unilateral stroke (infarction or haemorrhage).
- At least twelve months post onset.
- A unilateral paresis of the leg.
- A Functional Ambulation Categories Score (FAC) of 3 (*is capable of walking
when a safer environment with supervision or verbal guidance is provided'*) to
5 (*is independently capable of walking on flat and non-flat surfaces, on
slopes and is capable of walking the stairs*).
- Patient should be 18-70 years old at the time of inclusion.
- Written informed consent

Healthy controls:
- Participants should be 18-70 years old at the time of inclusion.
- Participants should match with one of the included patients on gender and
age.
- Written informed consent

Exclusion Criteria

Patients:
- Severely impaired cognitive functions (Mini Mental State Exam score <25).
- Severe speech, language or communication disorders (it will be left to
clinical judgment whether the patient is able to understand instructions and to
provide informed consent; in case of doubt the Aachen Aphasia Test will be
administered).
- Insufficient working knowledge of the Dutch language to understand
instructions and provide informed consent (clinical judgment).
- Severe visual problems (clinical judgment).
- Severe neglect (clinical judgment through observation. In case of doubt, the
Star Cancelation Test can be administered).
- Co-morbidity that can affect the results of the study (e.g. pre-existent
problems in leg function or a progressive neurological disorder).
- Participation in other scientific studies.
- Use of botulin toxin injections in the lower extremities or oral spasmolytic
in a period of two months prior to the measurement.
- Use of an active splint that delivers energy for forward propulsion.

Healthy controls:
- Suffer from neurological, orthopedical, somatosensory, visual, vestibular or
other conditions that are known to affect the gait pattern.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ground reaction forces.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(1) spatial and temporal gait variables, (2) EMG amplitudes of seven muscles of<br /><br>both legs, (3) hip, knee and ankle joint angles and (4) perceived exertion.</p><br>