Clinical trial NCT06187974: Relationship of Proprioception, Reaction Time and the Gait and Balance Parameters After Stroke
Official title: Assessment of the Relationship Between the Deficit of Proprioception, Reaction Time and the Parameters of Gait and Balance in Stroke Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 stroke survivors up to 3 months after the stroke - patients reffered to the Department of Rehabilitation, Clinical Regional Hospital number 2 in Rzeszow, Poland (study group) and 50 healthy volunteers matched for age and gender.

Brief summary: The aim of this observational study is to analyze how impaired proprioception affects the gait, reaction time, balance and functioning of stroke patients.

Research questions:

* Are there correlations between the deficit of proprioception and reaction time and the parameters of gait and balance as well as the functional state of stroke patients?
* Are there relationships between factors such as proprioception, reaction time, balance, functional status and gait, and time since stroke, the hemisphere where the stroke occurred, and gender?
* Are there differences in proprioception deficits and reaction times between the lower limbs in stroke survivors?

Participants will be assessed once using standard functional clinical tests and the rehabilitation devices.

Researchers will compare stroke patients and healthy volunteers to see, if there are differences in proprioception deficits, reaction time and balance.

Detailed description: For this prospective observational study, 50 ischemic - stroke survivors (study group) and 50 healthy volunteers matched for age and gender (control group) will be recruited. Study procedures will be performed in the morning including one-time functional assessment of proprioception, gait, balance and reaction time using standard clinical tests (Timed Up and Go Test, sit to stand test, 10m walk test, Wisconsin scale, Berg scale, Ashworth scale, Brunstrom scale, Barthel Scale, Rankin scale and FAC) and rehabilitation devices (Luna EMG - proprioception assessment, Pablo - gait parameters assessment, Omego Plus - proprioception assessment, ALFA stabilometric platform - balance and reaction time assessment).

Eligibility criteria: Inclusion Criteria:

* informed and voluntary consent of the patient,
* first-time stroke,
* hemiparesis,
* time from stroke to 3 months,
* age 30-75,
* grade 3-5 in the Functional Ambulation Category,
* walking without orthopedic support.

Exclusion Criteria:

* lack of informed and voluntary consent of the patient,
* second or subsequent stroke,
* stroke of the brainstem and cerebellum,
* epilepsy,
* disorders of higher mental functions,
* coexisting neurological, rheumatological, orthopedic diseases,
* use of orthopedic supplies during locomotion.

Primary outcomes:
measure: Correlation between the knee proprioception deficit (degree) and gait speed (m/s)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and gait time: 10-meter-Walk Test (seconds)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and gait cycle (steps/minute)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and cycle distance (cm)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and ambulation status: Functional Ambulation Category (points: minimum 0, maximum 5)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and kinematic and spatiotemporal gait parameters: Wisconsin scale (points: minimum 13.35, maximum 42)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and reaction time (miliseconds)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and balance parameter: lateral sways (cm)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and balance parameter: anterior-posterior sways (cm)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and balance parameter: path length (cm)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and balance parameter: lateral velocity (cm/s)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and balance parameter: anterio-posterior velocity (cm/s)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and balance parameter: COP area (cm2)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and balance: Berg Balance Scale (points: minimum 0, maximum 56)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and dynamic balance: Timed Up and Go Test (seconds)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and functional status: 5 times Sit To Stand Test (seconds)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and spasticity: Modified Ashworth Scale (points: minimum 0, maximum 4)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and functional status: Brunnstrom scale (points: minimum 1, maximum 6)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and functional status: Rankin scale (points: minimum 0, maximum 5)
timeFrame: September 2024
measure: Correlation between the knee proprioception deficit (degree) and functional status: Barthel scale (points: minimum 0, maximum 100)
timeFrame: September 2024
Secondary outcomes:
measure: Differences in knee proprioception deficit (degree).
timeFrame: December 2024
measure: Differences in gait speed (m/s)
timeFrame: December 2024
measure: Differences in gait time: 10-meter-Walk Test (seconds)
timeFrame: December 2024
measure: Differences in gait cycle (steps/minute)
timeFrame: December 2024
measure: Differences in cycle distance (cm)
timeFrame: December 2024
measure: Differences in ambulation status: Functional Ambulation Category (points: minimum 0, maximum 5)
timeFrame: December 2024
measure: Differences in kinematic and spatiotemporal gait parameters: Wisconsin scale (points: minimum 13.35, maximum 42)
timeFrame: December 2024
measure: Differences in reaction time (ms).
timeFrame: December 2024
measure: Differences in balance parameter: lateral sways (cm)
timeFrame: December 2024
measure: Differences in balance parameter: anterior-posterior sways (cm)
timeFrame: December 2024
measure: Differences in balance parameter: path length (cm)
timeFrame: December 2024
measure: Differences in balance parameter: lateral velocity (cm/s)
timeFrame: December 2024
measure: Differences in balance parameter: anterior-posterior velocity (cm/s)
timeFrame: December 2024
measure: Differences in balance parameter: COP area (cm2)
timeFrame: December 2024
measure: Differences in balance: Berg Balance Scale (points: minimum 0, maximum 56)
timeFrame: December 2024
measure: Differences in dynamic balance: Timed Up and Go Test (seconds)
timeFrame: December 2024
measure: Differences in functional status: 5 times Sit To Stand Test (seconds)
timeFrame: December 2024
measure: Differences in spasticity: Modified Ashworth Scale (points: minimum 0, maximum 4)
timeFrame: December 2024
measure: Differences in functional status: Brunnstrom scale (points: minimum 1, maximum 6)
timeFrame: December 2024
measure: Differences in functional status: Rankin scale (points: minimum 0, maximum 5)
timeFrame: December 2024
measure: Differences in functional status: Barthel scale (points: minimum 0, maximum 100)
timeFrame: December 2024
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: Department of Rehabilitation, Clinical Regional Hospital number 2
state: Podkarpackie
Study officials:
affiliation: Institute of Health Sciences, College of Medical Sciences, University of Rzeszów
name: Maciej Kochman, Dr.
role: PRINCIPAL_INVESTIGATOR
References: