HemiparesisNCT04672057
Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization
A study testing assessment of gait parameters in people with Hemiparesis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of lateralization on the spatio-temporal characteristics of gait in individuals with hemiparesis. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiparesis
- What is being tested?
- assessment of gait parameters
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jul 2017to 21 Jun 2018
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- for the hemiparetic individuals
- Being between the ages of 20-65,
- Having a stroke for the first time and one-sidedly,
- Having a stable clinical state,
- Having no cognitive disorder (Hodkinson Mental Test ≥ 8),
- Having ≤ 3 from Modified Rankin Score,
Show all 10Show fewer
- Having no problems with vision and hearing.
- for the healthy control group;
- Being between the ages of 20-65
- Having no neurological, musculosceletal, cardiac and cognitive problems that was undergone before and may affect walking.
Who cannot join
- The existence of vision and hearing problems in both study and control groups,
- The existence of orthopedic, neurological and psychiatric problems that may affect walking.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the effect of lateralization on the spatio-temporal characteristics of gait in individuals with hemiparesis.
Read the detailed description
A total of 108 individuals within the age range of 20-65 and 36 of whom are right hemiparetic (Group1; 16F, 20M), 36 of whom are left hemiparetic (Group2; 16F, 20M) and 36 of whom are healthy (Group3; 19F, 17M) have been included in the study. BTS G-Walk Gait Analysis System has been used to assess the spatio-temporal gait characteristics.
- Conditions
- Hemiparesis
- Being tested
- assessment of gait parameters
- Keywords
- Hemiparesis, Lateralization, Spatio-temporal analysis, Gait
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of gait parametersOther
Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area.
| Study group | Role | What they receive |
|---|---|---|
| Right hemiparetics | Active comparator | right-sided affected hemiparetic individuals Receives: Other: assessment of gait parameters |
| Left hemiparetics | Active comparator | left-sided affected hemiparetic individuals Receives: Other: assessment of gait parameters |
| Control | Active comparator | healthy individuals Receives: Other: assessment of gait parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of gait between in right and left hemiparetics
A port was attached to the patient's L5-S1 level. In the gait analysis system, the results was transferred to the computer via bluetooth with the analysis port. The resulting report was generated automatically. The report measured gait speed, cadence, right and left step length, right and left stride length, double and single stride length, pelvic rotation, pelvic tilt, and pelvic oblique.
Measured: Measurement time is 10 minutes. Only one measurement was made.
Secondary outcomes (1)
assessment of gait between in hemiparetic and healthy individuals
A port was attached to the patient's L5-S1 level. In the gait analysis system, the results was transferred to the computer via bluetooth with the analysis port. The resulting report was generated automatically. The report measured gait speed, cadence, right and left step length, right and left stride length, double and single stride length, pelvic rotation, pelvic tilt, and pelvic oblique.
Measured: Measurement time is 10 minutes. Only one measurement was made.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start8 Jul 2017
- Primary completion8 May 2018
- Study completion21 Jun 2018
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.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsum Tikac, Pamukkale University
- Investigators
- Gulsum Tikac, MSc Pt, Principal investigator, Pamukkale UniversityFiliz Altuğ, Prof Dr, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672057
- Sponsor's protocol ID
- Gait Parameter In Hemiparetics
- Status last verified
- Dec 2020
- First submitted
- 6 Dec 2020
- Last updated
- 17 Dec 2020
- 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 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization
- ClinicalTrials.gov ID
- NCT04672057
- Acronym / sponsor ID
- Gait Parameter In Hemiparetics
- Conditions
- Hemiparesis
- Keywords
- Hemiparesis, Lateralization, Spatio-temporal analysis, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 8 Jul 2017 (actual)
- Primary completion
- 8 May 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 17 Dec 2020 (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 aim of this study was to investigate the effect of lateralization on the spatio-temporal characteristics of gait in individuals with hemiparesis.
Detailed description
A total of 108 individuals within the age range of 20-65 and 36 of whom are right hemiparetic (Group1; 16F, 20M), 36 of whom are left hemiparetic (Group2; 16F, 20M) and 36 of whom are healthy (Group3; 19F, 17M) have been included in the study. BTS G-Walk Gait Analysis System has been used to assess the spatio-temporal gait characteristics.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Right hemiparetics | Active comparator | Other: assessment of gait parametersright-sided affected hemiparetic individuals |
| Left hemiparetics | Active comparator | Other: assessment of gait parametersleft-sided affected hemiparetic individuals |
| Control | Active comparator | Other: assessment of gait parametershealthy individuals |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- for the hemiparetic individuals
- Being between the ages of 20-65,
- Having a stroke for the first time and one-sidedly,
- Having a stable clinical state,
- Having no cognitive disorder (Hodkinson Mental Test ≥ 8),
Key exclusion criteria (2 listed)
- The existence of vision and hearing problems in both study and control groups,
- The existence of orthopedic, neurological and psychiatric problems that may affect walking.
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 |
|---|---|---|
| assessment of gait parametersGait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area. | Other | Control, Left hemiparetics, Right hemiparetics |
Primary outcome
assessment of gait between in right and left hemiparetics
Time frame: Measurement time is 10 minutes. Only one measurement was made.
A port was attached to the patient's L5-S1 level. In the gait analysis system, the results was transferred to the computer via bluetooth with the analysis port. The resulting report was generated automatically. The report measured gait speed, cadence, right and left step length, right and left stride length, double and single stride length, pelvic rotation, pelvic tilt, and pelvic oblique.
1 secondary outcome
assessment of gait between in hemiparetic and healthy individuals
Time frame: Measurement time is 10 minutes. Only one measurement was made.
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 17 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Hemiparesis
Not yet recruiting
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Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
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Recruiting
Telerehabilitation for Post-Stroke Hand Function
Stroke
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
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Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
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.
Gulsum Tikac, MSc Pt principal investigator
Pamukkale University
Filiz Altuğ, Prof Dr study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of gait parameters in people with Hemiparesis, run by Pamukkale 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 10 inclusion and 2 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 17 Dec 2020. 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?
assessment of gait between in right and left hemiparetics (time frame: Measurement time is 10 minutes. Only one measurement was made.). 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 17 Dec 2020.