Clinical trial NCT04069039: Is There a Relationship Between the Ability of the Trunk and Lower Extremities and Walking Function After Stroke?
Official title: Investigating the Relation Between Trunk Function and Function of the Lower Extremities in Relation to Post Stroke Gait
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
Trunk
Lower Extremities
Gait
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants suffers from a first stroke. Time after stroke can vary from two weeks untill six months after a stroke. The walking possibilities of these participants can fluctuate from walking independently on uneven ground to being unable to walk.

The measurements will take place only with participants hospitalized in a rehabilitation ward.

Brief summary: Stroke leads to impairments at different levels. Not only walking abilities are impaired after stroke but also trunk function, strength, balance and functional performance. Even in the latter phase after stroke, both walking abilities and trunk function remain restricted.

Restoring walking function is often the main goal of rehabilitation after stroke and the focus of post-stroke physiotherapy is often on regaining walking and mobility. Reduced walking ability after stroke is a predictor for discharge to a nursing home and associated with an increased probability of death. In addition, walking endurance, measured by a six-minute walking test, has a high correlation with community reintegration after a stroke.

Both trunk function and the ability to walk are often limited after stroke. A previous study observed that a significant correlation exists between these two functions, when measured with standardized clinical measurement scales . Due to the functional relevance and the link between both functions, further investigation however is warranted. Current lack of knowledge exists in investigating the relation between trunk and gait muscle strength, and this is key for informing clinical practice. For instance, should trunk muscle strength be a significant determinant of gait function, therapy should incorporate specific training for improving trunk muscle strength.

The primary objective of the study is to investigate if trunk muscle function in combination with lower limb muscle function are significant determinants of walking ability after stroke.

Secondly, the investigators will examine if there are other determinants such as cognition, balance, spasticity, ability of performing selective movements and sensitivity of the lower extremities for walking ability.


Eligibility criteria: Inclusion Criteria:

1. First stroke event.
2. Residence in a rehabilitation ward.
3. Two weeks until six months after a stroke event.
4. Older than 18 years.
5. With no comorbidities other than stroke affecting trunk function or walking ability.

   Comorbidities could be musculoskeletal problems or other neurological diseases.
6. With sufficient cognitive and language capacity to perform the assessment.

Exclusion Criteria:

1. Not able to give informed consent.
2. Not approved informed consent.
3. Subject does not understand the study procedures.
4. Subject has any history of a major neurological disorder.

Primary outcomes:
measure: Walking speed
timeFrame: In the rehabilitation phase (2 weeks to 6 months after stroke)
measure: Walking capacity
timeFrame: In the rehabilitation phase (2 weeks to 6 months after stroke)
measure: Walking endurance
timeFrame: In the rehabilitation phase (2 weeks to 6 months after stroke)
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Catholic University Leuven
Study officials:
affiliation: KU Leuven
name: Geert Verheyden, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verheyden G, Vereeck L, Truijen S, Troch M, Herregodts I, Lafosse C, Nieuwboer A, De Weerdt W. Trunk performance after stroke and the relationship with balance, gait and functional ability. Clin Rehabil. 2006 May;20(5):451-8. doi: 10.1191/0269215505cr955oa.