Skip to content

Muscle Trajectories in Acute Stroke Patients

Do Time-related Trajectories of Muscle Alterations Predict Gait Recovery in Acute Stroke Patients? A Study Protocol for Two Cohort Studies

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04337411
Enrollment
200
Registered
2020-04-07
Start date
2019-11-19
Completion date
2024-07-31
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Acute, Subacute, Muscle, Inflammation, Gait, Sarcopenia

Brief summary

The aim of this study is to explore time-related trajectories of muscle alterations and inflammation in acute hospitalized stroke patients. Furthermore, the researchers want to gain insight in the predictive values of these time-related trajectories towards gait recovery in the acute stroke population.

Detailed description

STUDY DESIGN: Two longitudinal prospective cohort studies will be conducted in which non-ambulatory (cohort 1) and ambulatory (cohort 2) acute stroke patients will participate. PATIENT RECRUITMENT: The investigators aim to recruit 200 subjects (100/cohort). Patients will be recruited at the Neurology ward of the UZ Brussel. PROCEDURE: All stroke survivors admitted to the Neurology ward of UZ Brussel will be screened for eligibility. Afterwards, an informed consent will be conducted for all subjects who met the inclusion criteria. Baseline assessments (T0) of gait recovery outcomes on the one hand and predictors for gait recovery on the other hand will be measured. To predict gait recovery, researchers will observe two novel biomarkers: stroke-induced muscle wasting and inflammation. Furthermore, the investigators will also assess relevant known predictors for gait recovery to compare the relevance of the novel markers. T0 assessments will start preferably within 3 days post-stroke. To assess time-related trajectories of muscle alterations and inflammation, follow-up assessments of these predictors will be performed 3 days after baseline assessments (T1), at discharge (T2) and 3 months follow-up (T3). T1 follow-up measurements will only be possible for patients with motor impairments post-stroke since they have a longer stay at the hospital compared to patients without motor impairments after stroke (mean hospital stay of 5 to 8 days for patients without or with motor impairments post-stroke respectively). The assessments of the gait recovery outcome measures will be repeated at discharge (T2) and 3 months follow-up (T3). MATERIALS: To measure gait recovery in acute stroke survivors, the researchers will make use of wearable gait sensors (Physiolog®, Gait Up SA, Switzerland) to register gait speed and a lightweight chest carrying gas analysis system (Metamax 3B, Cortex, Germany) to measure cardiorespiratory parameters. For the predictors, investigators will use handheld dynamometers (MicroFET2 and Martin Vigorimeter) to assess muscle strength, grip strength and muscle fatigue. Furthermore, researchers need a Bioelectrical Impedance analysis (BIA) device (Bodystat® QuadScan 4000, UK) to assess the muscle mass of our subjects and a portable ultrasound system (Viamo SV 7 with linear-array transducer, Canon Medical Systems, Netherlands) to assess muscle architecture. STATISTICAL ANALYSIS: Various biomarkers will be observed at each of the planned time points. Because the aim is to make correct predictions based on any information that is available at the early stages, the observations will not only be considered as such, but also summarized in terms of their time- related characteristics, such as steepest drop, frequency of improvement, or any other characteristic that may reveal itself as distinguishing. These predictors will be combined into predictive models such as random forests and boosting to establish the best combinations for making good predictions while accommodating inter-predictor correlations. The quality of the models will be established with cross-validation. The large set of observations and their summarized temporal characteristics will be used to determine whether different types of trajectories emerge. Hierarchical cluster analysis will label patients for each of the cluster solutions and the usefulness of patient labelling will be evaluated by their predicted gait performance. The extracted patient type will be included in random forests or boosting to evaluate its importance. The extracted patient type could also be used jointly with other predictors suggested as important in either a linear/logistic (mixed) model or an extended cox proportional hazard model, which are more traditional statistical approaches. While predictive performance remains the key goal, such models would be more interpretable on the potential underlying mechanism, with parameter estimates and confidence intervals.

Interventions

Longitudinal evaluation of recovery

Sponsors

Universitair Ziekenhuis Brussel
CollaboratorOTHER
Vrije Universiteit Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults (≥18 years) * Hospitalized at the Neurology ward of UZ Brussel * Diagnosed with first-ever stroke (as defined by the World Health Organisation) * Able to provide written or verbal informed consent

Exclusion criteria

* Other neurological or orthopaedic problems leading to impaired gait * Severe deficits of communication, memory or understanding

Design outcomes

Primary

MeasureTime frameDescription
Functional Ambulation CategoriesChange over time between baseline (≤ 3 days post-stroke), discharge (anticipated average of 10 days post-stroke) and 3 months follow-upThe Functional Ambulation Categories (FAC) will be used to measure walking ability in patients assigned to cohort 1. The score ranges from 0-5, with a higher score reflecting towards a more independent walking ability.
6-minutes walking testChange over time between baseline (≤ 3 days post-stroke), discharge (anticipated average of 10 days post-stroke) and 3 months follow-upThe 6-minutes walking test (6MWT) will evaluate the walking endurance of the subjects in cohort 2. During this test we will measure the distance walked over a span of 6 minutes.

Secondary

MeasureTime frameDescription
Oxygen costBaseline (≤ 3 days post-stroke), discharge (anticipated average 10 days post-stroke), 3 monthsOxygen cost (ml/kg/m) will be observed by respiratory gas analysis with the MetaMax 3B. All subjects from cohort 2 will wear this system during their 6MWT.
Muscle strengthBaseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 monthsMuscle strength of the lower extremities will be assessed on one hand with the Motricity Index, a clinical tool which measures strength in the ankle dorsiflexors, knee extensors and hip flexors. On the other hand, we will use a hand-held dynamometer (MicroFET2) to assess the maximal isometric muscle strength of the knee extensors and ankle dorsiflexors (Newton) on the paretic and non-paretic side.
Grip strengthBaseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 monthsMaximal hand grip strength will be assessed with the Martin Vigorimeter (KPa) on both sides.
Muscle FatigueBaseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 monthsTo observe muscle fatigue, we will use the Martin Vigorimeter. Muscle fatigue is defined as the time during which handgrip strength drops to 50% of its maximal value during sustained maximal contraction.
Muscle MassBaseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 monthsA bioelectrical impedance analysis (BIA) system will be used to assess the muscle mass of the subjects.
Rivermead Mobility IndexBaseline (≤ 3 days post-stroke), discharge (anticipated average 10 days post-stroke), 3 monthsThe Rivermead Mobility Index (RMI) will assess functional mobility in gait, balance and transfers in subjects of cohort 1. The RMI consists of 14 self-reported items and 1 direct observation with an overall maximum score of 15 points. A higher score represents a better outcome.
Muscle ToneBaseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 monthsThe Modified Ashworth Scale (MAS) will evaluate the amount of spasticity on both sides in the m. quadriceps, m. gastrocnemius and m. soleus based on a 6-point ordinal scale, with a higher score reflecting towards more spasticity in the muscle.
Circulating biomarkersBaseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 monthsThrough blood sampling we investigate following circulating biomarkers: Brain-derived neurotrophic Factor (BDNF), inflammation related biomarkers (CRP, IL1β, TNFα, IL1ra, IL6, IL-8, IL-10, IL-15), heat shock proteins (hsp) (hsp27 and hsp 70) and Irisin.
Short Physical Performance BatteryBaseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 monthsThe Short Physical Performance Battery (SPPB) will be used to evaluate balance and mobility of the subjects. It is a test which combines the results of a gait speed test, a balance test and a chair stand test.
Fatigue Assessment ScaleBaseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 monthsThe Fatigue Assessment Scale (FAS) will be used to assess physical and mental fatigue. The questionnaire consists of 10 statements which have to be answered with one out of five categories varying from never to always.
Muscle architectureBaseline (≤ 3 days post-stroke), 3 days after baseline assessment, discharge (anticipated average 10 days post-stroke), 3 monthsWe will use ultrasound technique to evaluate the muscle architecture of the m. tibialis anterior and the m. gastrocnemius medialis. The architectural qualities of the muscles involve: muscle thickness, pennation angle, fascicle length and cross-sectional area.
Gait speedBaseline (≤ 3 days post-stroke), discharge (anticipated average 10 days post-stroke), 3 monthsGait speed (m/s) will be evaluated by using wearable motion sensors (Gait Up) during the 6MWT in patients assigned to cohort 2.

Countries

Belgium

Contacts

Primary ContactLotte Cuypers, Dra.
lotte.cuypers@vub.be00324774505
Backup ContactEva Swinnen, Prof. Ph.D
eva.swinnen@vub.be003224774529

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026