NCT04672057

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

10 months

First QC Date

December 6, 2020

Last Update Submit

December 11, 2020

Conditions

Keywords

HemiparesisLateralizationSpatio-temporal analysisGait

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • assessment of gait between in hemiparetic and healthy individuals

    Measurement time is 10 minutes. Only one measurement was made.

Study Arms (3)

Right hemiparetics

ACTIVE COMPARATOR

right-sided affected hemiparetic individuals

Other: assessment of gait parameters

Left hemiparetics

ACTIVE COMPARATOR

left-sided affected hemiparetic individuals

Other: assessment of gait parameters

Control

ACTIVE COMPARATOR

healthy individuals

Other: assessment of gait parameters

Interventions

Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area.

ControlLeft hemipareticsRight hemiparetics

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gulsum Tikac, MSc Pt

    Pamukkale University

    PRINCIPAL INVESTIGATOR
  • Filiz Altuğ, Prof Dr

    Pamukkale University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 6, 2020

First Posted

December 17, 2020

Study Start

July 8, 2017

Primary Completion

May 8, 2018

Study Completion

June 21, 2018

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations