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StrokeNCT06187974

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

An observational study of Stroke, run by University of Rzeszow at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
observation
How many people
132 participants
Where
1 sitePoland
Study dates
8 Nov 2023to 31 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Department of Rehabilitation, Clinical Regional Hospital number 2

    Rzeszów, Podkarpackie Voivodeship, 35-301

Other trials in Poland

About this study

Official title: 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:

Read more
  • 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.

Read the 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).

Conditions
Stroke
Being tested
observation
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • observationOther

    observation

Study groups in NCT06187974
Study groupRoleWhat they receive
Study groupstroke patients
Receives: Other: observation
Control grouphealthy volunteers
Receives: Other: observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: September 2024

  2. 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)

    Measured: September 2024

  3. 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)

    Measured: September 2024

  4. 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)

    Measured: September 2024

  5. 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

    Measured: September 2024

  6. 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

    Measured: September 2024

  7. 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)

    Measured: September 2024

  8. 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)

    Measured: September 2024

  9. 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)

    Measured: September 2024

  10. 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)

    Measured: September 2024

  11. 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)

    Measured: September 2024

  12. 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)

    Measured: September 2024

  13. 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

    Measured: September 2024

  14. 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

    Measured: September 2024

  15. 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

    Measured: September 2024

  16. 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

    Measured: September 2024

  17. 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

    Measured: September 2024

  18. 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

    Measured: September 2024

  19. 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

    Measured: September 2024

  20. 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

    Measured: September 2024

Secondary outcomes (21)
  1. Differences in knee proprioception deficit (degree).

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

    Measured: December 2024

  2. Differences in gait speed (m/s)

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

    Measured: December 2024

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

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

    Measured: December 2024

  4. Differences in gait cycle (steps/minute)

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

    Measured: December 2024

  5. Differences in cycle distance (cm)

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

    Measured: December 2024

  6. 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

    Measured: December 2024

  7. 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

    Measured: December 2024

  8. Differences in reaction time (ms).

    Reaction time will be assessed using stabilometric platform (Alfa)

    Measured: December 2024

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

    Lateral sways will be assessed using stabilometric platform (Alfa)

    Measured: December 2024

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

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

    Measured: December 2024

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

    Path length will be assessed using stabilometric platform (Alfa)

    Measured: December 2024

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

    Lateral velocity will be assessed using stabilometric platform (Alfa)

    Measured: December 2024

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

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

    Measured: December 2024

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

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

    Measured: December 2024

  15. 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

    Measured: December 2024

  16. 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

    Measured: December 2024

  17. 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

    Measured: December 2024

  18. 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

    Measured: December 2024

  19. 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

    Measured: December 2024

  20. 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

    Measured: December 2024

  21. 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

    Measured: December 2024

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2024
  2. Study start8 Nov 2023
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06187974
Sponsor's protocol ID
Mkochman
Status last verified
Apr 2024
First submitted
3 Jul 2023
Last updated
7 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by University of Rzeszow at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between the knee proprioception deficit (degree) and gait speed (m/s) (time frame: September 2024). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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