- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05027841
Proprioception on Balance and Gait in Hemiparetics
August 25, 2021 updated by: Seref Duhan Altug, Istanbul Aydın University
Investigation of The Effect of Proprioception on Balance and Gait Functions in Hemiparetic Individuals
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
28
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- İstanbul Aydın University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Hemiparetic individuals
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensorial Assessment-1
Time Frame: 2 minutes
|
Semmes-Weinstein Monoflament
|
2 minutes
|
Sensorial Assessment-2
Time Frame: 2 minutes
|
Position test for lower extremity
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2 minutes
|
Sensorial Assessment-3
Time Frame: 2 minutes
|
Kinestesia (Electrogoniometer)
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2 minutes
|
Balance assessment
Time Frame: 30 second
|
Static balance via SportKAT-550
|
30 second
|
Gait parameters
Time Frame: 1 minute
|
BTS G-Walk Spatiotemporal gait parameters
|
1 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 13, 2021
Primary Completion (ANTICIPATED)
July 13, 2022
Study Completion (ANTICIPATED)
August 13, 2022
Study Registration Dates
First Submitted
August 25, 2021
First Submitted That Met QC Criteria
August 25, 2021
First Posted (ACTUAL)
August 30, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 25, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-60116787-020-5302
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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