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

Sponsor

Pamukkale University (Other)

Overall Status

Completed

CT.gov ID

NCT04672057

Collaborator

(none)

108

Enrollment

Location

Arms

11.4

Actual Duration (Months)

9.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemiparesis	Other: assessment of gait parameters	N/A

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

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 8, 2017

Actual Primary Completion Date :

May 8, 2018

Actual Study Completion Date :

Jun 21, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

assessment of gait between in right and left hemiparetics [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.

Secondary Outcome Measures

assessment of gait between in hemiparetic and healthy individuals [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pamukkale University	Denizli		Turkey	20100

Sponsors and Collaborators

Pamukkale University

Investigators

Principal Investigator: Gulsum Tikac, MSc Pt, Pamukkale University
Study Director: Filiz Altuğ, Prof Dr, Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gulsum Tikac, Principal Investigator, Pamukkale University

ClinicalTrials.gov Identifier:

NCT04672057

Other Study ID Numbers:

Gait Parameter In Hemiparetics

First Posted:

Dec 17, 2020

Last Update Posted:

Dec 17, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gulsum Tikac, Principal Investigator, Pamukkale University

Hemiparesis

Lateralization

Spatio-temporal analysis

Gait

Additional relevant MeSH terms:

Paresis

Study Results

No Results Posted as of Dec 17, 2020