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Completed

NCT Number: NCT06187974

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Rehabilitation, Clinical Regional Hospital number 2

Rzeszów, Podkarpackie Voivodeship, 35-301, Poland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

observation

Other

observation

Primary outcomes

  1. Correlation between the knee proprioception deficit (degree) and gait speed (m/s)

    Time frame: September 2024

    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)

  2. Correlation between the knee proprioception deficit (degree) and gait time: 10-meter-Walk Test (seconds)

    Time frame: September 2024

    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)

  3. Correlation between the knee proprioception deficit (degree) and gait cycle (steps/minute)

    Time frame: September 2024

    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)

  4. Correlation between the knee proprioception deficit (degree) and cycle distance (cm)

    Time frame: September 2024

    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)

  5. Correlation between the knee proprioception deficit (degree) and ambulation status: Functional Ambulation Category (points: minimum 0, maximum 5)

    Time frame: September 2024

    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

  6. Correlation between the knee proprioception deficit (degree) and kinematic and spatiotemporal gait parameters: Wisconsin scale (points: minimum 13.35, maximum 42)

    Time frame: September 2024

    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

  7. Correlation between the knee proprioception deficit (degree) and reaction time (miliseconds)

    Time frame: September 2024

    The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG and the reaction time will be assessed using stabilometric platform (Alfa)

  8. Correlation between the knee proprioception deficit (degree) and balance parameter: lateral sways (cm)

    Time frame: September 2024

    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)

  9. Correlation between the knee proprioception deficit (degree) and balance parameter: anterior-posterior sways (cm)

    Time frame: September 2024

    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)

  10. Correlation between the knee proprioception deficit (degree) and balance parameter: path length (cm)

    Time frame: September 2024

    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)

  11. Correlation between the knee proprioception deficit (degree) and balance parameter: lateral velocity (cm/s)

    Time frame: September 2024

    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)

  12. Correlation between the knee proprioception deficit (degree) and balance parameter: anterio-posterior velocity (cm/s)

    Time frame: September 2024

    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)

  13. Correlation between the knee proprioception deficit (degree) and balance parameter: COP area (cm2)

    Time frame: September 2024

    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

  14. Correlation between the knee proprioception deficit (degree) and balance: Berg Balance Scale (points: minimum 0, maximum 56)

    Time frame: September 2024

    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

  15. Correlation between the knee proprioception deficit (degree) and dynamic balance: Timed Up and Go Test (seconds)

    Time frame: September 2024

    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

  16. Correlation between the knee proprioception deficit (degree) and functional status: 5 times Sit To Stand Test (seconds)

    Time frame: September 2024

    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

  17. Correlation between the knee proprioception deficit (degree) and spasticity: Modified Ashworth Scale (points: minimum 0, maximum 4)

    Time frame: September 2024

    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

  18. Correlation between the knee proprioception deficit (degree) and functional status: Brunnstrom scale (points: minimum 1, maximum 6)

    Time frame: September 2024

    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

  19. Correlation between the knee proprioception deficit (degree) and functional status: Rankin scale (points: minimum 0, maximum 5)

    Time frame: September 2024

    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

  20. Correlation between the knee proprioception deficit (degree) and functional status: Barthel scale (points: minimum 0, maximum 100)

    Time frame: September 2024

    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

Secondary outcomes

  1. Differences in knee proprioception deficit (degree).

    Time frame: December 2024

    The knee proprioception deficit (degree) will be assessed by rehabilitation robot Luna EMG

  2. Differences in gait speed (m/s)

    Time frame: December 2024

    Gait speed will be assessed using inertial sensors (Pablo device)

  3. Differences in gait time: 10-meter-Walk Test (seconds)

    Time frame: December 2024

    Gait time will be assessed using inertial sensors (Pablo device)

  4. Differences in gait cycle (steps/minute)

    Time frame: December 2024

    Gait cycle will be assessed using inertial sensors (Pablo device)

  5. Differences in cycle distance (cm)

    Time frame: December 2024

    Cycle distance will be assessed using inertial sensors (Pablo device)

  6. Differences in ambulation status: Functional Ambulation Category (points: minimum 0, maximum 5)

    Time frame: December 2024

    The ambulation status will be assessed using standard clinical scale: Functional Ambulation Category. Less points indicate worse ambulation category

  7. Differences in kinematic and spatiotemporal gait parameters: Wisconsin scale (points: minimum 13.35, maximum 42)

    Time frame: December 2024

    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

  8. Differences in reaction time (ms).

    Time frame: December 2024

    Reaction time will be assessed using stabilometric platform (Alfa)

  9. Differences in balance parameter: lateral sways (cm)

    Time frame: December 2024

    Lateral sways will be assessed using stabilometric platform (Alfa)

  10. Differences in balance parameter: anterior-posterior sways (cm)

    Time frame: December 2024

    Anterior-posterior sways will be assessed using stabilometric platform (Alfa)

  11. Differences in balance parameter: path length (cm)

    Time frame: December 2024

    Path length will be assessed using stabilometric platform (Alfa)

  12. Differences in balance parameter: lateral velocity (cm/s)

    Time frame: December 2024

    Lateral velocity will be assessed using stabilometric platform (Alfa)

  13. Differences in balance parameter: anterior-posterior velocity (cm/s)

    Time frame: December 2024

    Anterior-posterior velocity will be assessed using stabilometric platform (Alfa)

  14. Differences in balance parameter: COP area (cm2)

    Time frame: December 2024

    This balance parameter will be assessed using stabilometric platform (Alfa); COP - center of pressure

  15. Differences in balance: Berg Balance Scale (points: minimum 0, maximum 56)

    Time frame: December 2024

    Balance will be assessed using standard clinical scale: Berg Balance Scale. Less points indicate worse balance

  16. Differences in dynamic balance: Timed Up and Go Test (seconds)

    Time frame: December 2024

    Dynamic balance will be assessed using standard clinical scale Timed Up and Go Test. Longer time of performing test indicates worse dynamic balance

  17. Differences in functional status: 5 times Sit To Stand Test (seconds)

    Time frame: December 2024

    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

  18. Differences in spasticity: Modified Ashworth Scale (points: minimum 0, maximum 4)

    Time frame: December 2024

    The spasticity will be assessed using standard clinical scale: Modified Ashworth Scale. Better score indicates worse spasticity

  19. Differences in functional status: Brunnstrom scale (points: minimum 1, maximum 6)

    Time frame: December 2024

    The functional status will be assessed using standard clinical scale: Brunnstrom scale. Better score indicates better functional status

  20. Differences in functional status: Rankin scale (points: minimum 0, maximum 5)

    Time frame: December 2024

    The functional status will be assessed using standard clinical scale: Rankin scale. Better score indicates worse functional status

  21. Differences in functional status: Barthel scale (points: minimum 0, maximum 100)

    Time frame: December 2024

    The functional status will be assessed using standard clinical scale: Barthel scale. Better score indicates better functional status

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2024
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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