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

The aim of this study was to investigate the effect of lateralization on the spatio-temporal characteristics of gait in individuals with hemiparesis.

Study Overview

• Status: Completed
• Conditions: Hemiparesis
• Intervention / Treatment: Other: assessment of gait parameters

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 Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20100
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Right hemiparetics; right-sided affected hemiparetic individuals	Other: assessment of gait parameters; Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area.
Active Comparator: Left hemiparetics; left-sided affected hemiparetic individuals	Other: assessment of gait parameters; Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area.
Active Comparator: Control; healthy individuals	Other: assessment of gait parameters; Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurement time is 10 minutes. Only one measurement was made.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Measurement time is 10 minutes. Only one measurement was made.

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2017
• Primary Completion (Actual): May 8, 2018
• Study Completion (Actual): June 21, 2018

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 11, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Gait; Hemiparesis; Lateralization; Spatio-temporal analysis
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: Gait Parameter In Hemiparetics

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