Relationship of Proprioception, Reaction Time and the Gait and Balance Parameters After Stroke

Assessment of the Relationship Between the Deficit of Proprioception, Reaction Time and the Parameters of Gait and Balance in Stroke Patients

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: observation

Detailed Description

For this prospective observational study, ischemic - stroke survivors (study group) and 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).

• Study Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• Poland
  • Podkarpackie Voivodeship
    • Rzeszów, Podkarpackie Voivodeship, Poland, 35-301
      • Department of Rehabilitation, Clinical Regional Hospital number 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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 healthy volunteers matched for age and gender.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; healthy volunteers	Other: observation; observation
Study group; stroke patients	Other: observation; observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the knee proprioception deficit (degree) and gait speed (m/s)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and gait speed (m/s) will be assessed using inertial sensors (Pablo device)	September 2024
Correlation between the knee proprioception deficit (degree) and gait time: 10-meter-Walk Test (seconds)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and gait time (seconds) will be assessed using inertial sensors (Pablo device)	September 2024
Correlation between the knee proprioception deficit (degree) and gait cycle (steps/minute)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and gait cycle (steps/minute) will be assessed using inertial sensors (Pablo device)	September 2024
Correlation between the knee proprioception deficit (degree) and cycle distance (cm)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and cycle distance (cm) will be assessed using inertial sensors (Pablo device)	September 2024
Correlation between the knee proprioception deficit (degree) and ambulation status: Functional Ambulation Category (points: minimum 0, maximum 5)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the ambulation status will be assessed using standard clinical scale: Functional Ambulation Category. Less points indicate worse ambulation category	September 2024
Correlation between the knee proprioception deficit (degree) and kinematic and spatiotemporal gait parameters: Wisconsin scale (points: minimum 13.35, maximum 42)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the kinematic and spatiotemporal gait parameters will be assessed using standard clinical scale: Wisconsin scale. The higher the score the more seriously affected the gait	September 2024
Correlation between the knee proprioception deficit (degree) and reaction time (miliseconds)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the reaction time will be assessed using stabilometric platform (Alfa)	September 2024
Correlation between the knee proprioception deficit (degree) and balance parameter: lateral sways (cm)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the lateral sways (cm) will be assessed using stabilometric platform (Alfa)	September 2024
Correlation between the knee proprioception deficit (degree) and balance parameter: anterior-posterior sways (cm)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the anterior-posterior sways (cm) will be assessed using stabilometric platform (Alfa)	September 2024
Correlation between the knee proprioception deficit (degree) and balance parameter: path length (cm)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the path length (cm) will be assessed using stabilometric platform (Alfa)	September 2024
Correlation between the knee proprioception deficit (degree) and balance parameter: lateral velocity (cm/s)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the lateral velocity (cm/s) will be assessed using stabilometric platform (Alfa)	September 2024
Correlation between the knee proprioception deficit (degree) and balance parameter: anterio-posterior velocity (cm/s)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the anterior-posterior velocity (cm/s) will be assessed using stabilometric platform (Alfa)	September 2024
Correlation between the knee proprioception deficit (degree) and balance parameter: COP area (cm2)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the COP area (cm2) will be assessed using stabilometric platform (Alfa). COP - center of pressure	September 2024
Correlation between the knee proprioception deficit (degree) and balance: Berg Balance Scale (points: minimum 0, maximum 56)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the balance will be assessed using standard clinical scale: Berg Balance Scale. Less points indicate worse balance	September 2024
Correlation between the knee proprioception deficit (degree) and dynamic balance: Timed Up and Go Test (seconds)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the dynamic balance will be assessed using standard clinical scale Timed Up and Go Test. Longer time of performing test indicates worse dynamic balance	September 2024
Correlation between the knee proprioception deficit (degree) and functional status: 5 times Sit To Stand Test (seconds)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the functional status will be assessed using standard clinical scale: 5 times Sit To Stand Test. Longer time of performing test indicates worse functional status	September 2024
Correlation between the knee proprioception deficit (degree) and spasticity: Modified Ashworth Scale (points: minimum 0, maximum 4)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the spasticity will be assessed using standard clinical scale: Modified Ashworth Scale. Better score indicates worse spasticity	September 2024
Correlation between the knee proprioception deficit (degree) and functional status: Brunnstrom scale (points: minimum 1, maximum 6)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the functional status will be assessed using standard clinical scale: Brunnstrom scale. Better score indicates better functional status	September 2024
Correlation between the knee proprioception deficit (degree) and functional status: Rankin scale (points: minimum 0, maximum 5)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the functional status will be assessed using standard clinical scale: Rankin scale. Better score indicates worse functional status	September 2024
Correlation between the knee proprioception deficit (degree) and functional status: Barthel scale (points: minimum 0, maximum 100)	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the functional status will be assessed using standard clinical scale: Barthel. Better score indicates better functional status	September 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in knee proprioception deficit (degree).	The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG	December 2024
Differences in gait speed (m/s)	Gait speed will be assessed using inertial sensors (Pablo device)	December 2024
Differences in gait time: 10-meter-Walk Test (seconds)	Gait time will be assessed using inertial sensors (Pablo device)	December 2024
Differences in gait cycle (steps/minute)	Gait cycle will be assessed using inertial sensors (Pablo device)	December 2024
Differences in cycle distance (cm)	Cycle distance will be assessed using inertial sensors (Pablo device)	December 2024
Differences in ambulation status: Functional Ambulation Category (points: minimum 0, maximum 5)	The ambulation status will be assessed using standard clinical scale: Functional Ambulation Category. Less points indicate worse ambulation category	December 2024
Differences in kinematic and spatiotemporal gait parameters: Wisconsin scale (points: minimum 13.35, maximum 42)	The kinematic and spatiotemporal gait parameters will be assessed using standard clinical scale: Wisconsin scale. The higher the score the more seriously affected the gait	December 2024
Differences in reaction time (ms).	Reaction time will be assessed using stabilometric platform (Alfa)	December 2024
Differences in balance parameter: lateral sways (cm)	Lateral sways will be assessed using stabilometric platform (Alfa)	December 2024
Differences in balance parameter: anterior-posterior sways (cm)	Anterior-posterior sways will be assessed using stabilometric platform (Alfa)	December 2024
Differences in balance parameter: path length (cm)	Path length will be assessed using stabilometric platform (Alfa)	December 2024
Differences in balance parameter: lateral velocity (cm/s)	Lateral velocity will be assessed using stabilometric platform (Alfa)	December 2024
Differences in balance parameter: anterior-posterior velocity (cm/s)	Anterior-posterior velocity will be assessed using stabilometric platform (Alfa)	December 2024
Differences in balance parameter: COP area (cm2)	This balance parameter will be assessed using stabilometric platform (Alfa); COP - center of pressure	December 2024
Differences in balance: Berg Balance Scale (points: minimum 0, maximum 56)	Balance will be assessed using standard clinical scale: Berg Balance Scale. Less points indicate worse balance	December 2024
Differences in dynamic balance: Timed Up and Go Test (seconds)	Dynamic balance will be assessed using standard clinical scale Timed Up and Go Test. Longer time of performing test indicates worse dynamic balance	December 2024
Differences in functional status: 5 times Sit To Stand Test (seconds)	The functional status will be assessed using standard clinical scale: 5 times Sit To Stand Test. Longer time of performing test indicates worse functional status	December 2024
Differences in spasticity: Modified Ashworth Scale (points: minimum 0, maximum 4)	The spasticity will be assessed using standard clinical scale: Modified Ashworth Scale. Better score indicates worse spasticity	December 2024
Differences in functional status: Brunnstrom scale (points: minimum 1, maximum 6)	The functional status will be assessed using standard clinical scale: Brunnstrom scale. Better score indicates better functional status	December 2024
Differences in functional status: Rankin scale (points: minimum 0, maximum 5)	The functional status will be assessed using standard clinical scale: Rankin scale. Better score indicates worse functional status	December 2024
Differences in functional status: Barthel scale (points: minimum 0, maximum 100)	The functional status will be assessed using standard clinical scale: Barthel scale. Better score indicates better functional status	December 2024

Collaborators and Investigators

• Sponsor: University of Rzeszow
• Investigators: Principal Investigator: Maciej Kochman, Dr., Institute of Health Sciences, College of Medical Sciences, University of Rzeszów

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: Mkochman

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No