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

NCT06187974 | Unknown

• 1 other identifier: Mkochman
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (21)

• Differences in knee proprioception deficit (degree).

  December 2024

• Differences in gait speed (m/s)

  December 2024

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

  December 2024

• Differences in gait cycle (steps/minute)

  December 2024

• Differences in cycle distance (cm)

  December 2024

Study Arms (2)

Study group

stroke patients

Other: observation

Control group

healthy volunteers

Other: observation

Interventions

observation OTHER

observation

Control group; Study group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

Department of Rehabilitation, Clinical Regional Hospital number 2

Rzeszów, Podkarpackie Voivodeship, 35-301, Poland

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Maciej Kochman, Dr.

  Institute of Health Sciences, College of Medical Sciences, University of Rzeszów

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maciej Kochman, Dr.

CONTACT

888500541; mkochman@ur.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: January 3, 2024
• Study Start: November 8, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

PL (1)