NCT05027841

Brief Summary

The loss of sensorial feedback causes gait impairment in hemiparesis. The studies show that proprioceptive impairment of knee is related to falling in these patients. The aim of this study is to investigate the effects of proprioception on balance and gait functions in hemiparetic individuals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2022

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

August 25, 2021

Last Update Submit

February 20, 2025

Conditions

HemiparesisProprioceptive DisordersGait, Hemiplegic

Outcome Measures

Primary Outcomes (5)

  • Sensorial Assessment-1

    Semmes-Weinstein Monoflament

    2 minutes

  • Sensorial Assessment-2

    Position test for lower extremity

    2 minutes

  • Sensorial Assessment-3

    Kinestesia (Electrogoniometer)

    2 minutes

  • Balance assessment

    Static balance via SportKAT-550

    30 second

  • Gait parameters

    BTS G-Walk Spatiotemporal gait parameters

    1 minute

Interventions

Proprioseption in hemipareticsOTHER

Proprioception on balance and gait functions in hemiparetic individuals

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hemiparetic individuals

You may qualify if:

  • Between the ages of 20-65 and discharged from the hospital,
  • Diagnosed with hemiparesis at least 4 weeks ago,
  • First time and unilateral hemiparesis,
  • Modified Rankin Score ≤ 3,
  • Hodkinson Mental Test ≥ 6,
  • Individuals who agree to receive treatment will be included in the study.

You may not qualify if:

  • Having vision and hearing problems,
  • Having other accompanying neurological, psychiatric and/or orthopedic problems other than hemiparesis,
  • Medically unstable,
  • Diseases that will affect the lower extremity sense,
  • Individuals with open wounds, circulation problems, and skin lesions in the area to be treated will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydın University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

ParesisSomatosensory DisordersGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSensation Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 30, 2021

Study Start

August 13, 2021

Primary Completion

July 13, 2022

Study Completion

August 13, 2022

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)