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Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization

Primary Purpose

Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
assessment of gait parameters
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemiparesis focused on measuring Hemiparesis, Lateralization, Spatio-temporal analysis, Gait

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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,
  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Right hemiparetics

Left hemiparetics

Control

Arm Description

right-sided affected hemiparetic individuals

left-sided affected hemiparetic individuals

healthy individuals

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 6, 2020
Last Updated
December 11, 2020
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04672057
Brief Title
Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization
Official Title
Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 8, 2017 (Actual)
Primary Completion Date
May 8, 2018 (Actual)
Study Completion Date
June 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis
Keywords
Hemiparesis, Lateralization, Spatio-temporal analysis, Gait

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right hemiparetics
Arm Type
Active Comparator
Arm Description
right-sided affected hemiparetic individuals
Arm Title
Left hemiparetics
Arm Type
Active Comparator
Arm Description
left-sided affected hemiparetic individuals
Arm Title
Control
Arm Type
Active Comparator
Arm Description
healthy individuals
Intervention Type
Other
Intervention Name(s)
assessment of gait parameters
Intervention Description
Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area.
Primary Outcome Measure Information:
Title
assessment of gait between in right and left hemiparetics
Description
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.
Time Frame
Measurement time is 10 minutes. Only one measurement was made.
Secondary Outcome Measure Information:
Title
assessment of gait between in hemiparetic and healthy individuals
Description
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.
Time Frame
Measurement time is 10 minutes. Only one measurement was made.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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, 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulsum Tikac, MSc Pt
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Filiz Altuğ, Prof Dr
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of the Spatio-temporal Gait Parameters in Individuals With Hemiparesis: Effect of Lateralization

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