HemiparesisNCT05027841
Proprioception on Balance and Gait in Hemiparetics
An observational study of Hemiparesis and Proprioceptive Disorders, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Hemiparesis, Proprioceptive Disorders, Gait, Hemiplegic
- What is being tested?
- Proprioseption in hemiparetics
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Aug 2021to 13 Aug 2022
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hemiparetic individuals
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hemiparesis, Proprioceptive Disorders, Gait, Hemiplegic
- Being tested
- Proprioseption in hemiparetics
- Medical subject headings
- Paresis, Somatosensory Disorders, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioseption in hemipareticsOther
Proprioception on balance and gait functions in hemiparetic individuals
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensorial Assessment-1
Semmes-Weinstein Monoflament
Measured: 2 minutes
Sensorial Assessment-2
Position test for lower extremity
Measured: 2 minutes
Sensorial Assessment-3
Kinestesia (Electrogoniometer)
Measured: 2 minutes
Balance assessment
Static balance via SportKAT-550
Measured: 30 second
Gait parameters
BTS G-Walk Spatiotemporal gait parameters
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start13 Aug 2021
- Primary completion13 Jul 2022
- Study completion13 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seref Duhan Altug, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05027841
- Sponsor's protocol ID
- E-60116787-020-5302
- Status last verified
- Feb 2025
- First submitted
- 25 Aug 2021
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of The Effect of Proprioception on Balance and Gait Functions in Hemiparetic Individuals
- ClinicalTrials.gov ID
- NCT05027841
- Acronym / sponsor ID
- E-60116787-020-5302
- Conditions
- Hemiparesis, Proprioceptive Disorders, Gait, Hemiplegic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 13 Aug 2022 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemiparetic individuals
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioseption in hemipareticsProprioception on balance and gait functions in hemiparetic individuals | Other | – |
Primary outcome
Sensorial Assessment-1
Time frame: 2 minutes
Semmes-Weinstein Monoflament
Sensorial Assessment-2
Time frame: 2 minutes
Position test for lower extremity
Sensorial Assessment-3
Time frame: 2 minutes
Kinestesia (Electrogoniometer)
Balance assessment
Time frame: 30 second
Static balance via SportKAT-550
Gait parameters
Time frame: 1 minute
BTS G-Walk Spatiotemporal gait parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiparesis and Proprioceptive Disorders, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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 21 Feb 2025. 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 Turkey (Türkiye). 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?
Sensorial Assessment-1 (time frame: 2 minutes). The study lists 5 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 21 Feb 2025.