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Microsoft Kinect, Gait Function,Hemineglect, Vestibulo-ocular Training

Primary Purpose

Hemiplegic Gait

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

vestibuloocular training

regular exercise training for hemiplegic patients

About this trial

This is an interventional treatment trial for Hemiplegic Gait

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects age will range from (60-70) years old.
Patients who had a stroke at least six months prior.
Patients who had visual field defects post stroke.
Patients who could walk without caretaker assistance or no severe dyskinesias.
Adequate hearing (hearing aid if required).
Patients who had no problem with their state of consciousness and absence of dementia
Patients who had no orthopedic problems that may affect gait.
Patients will be chosen in both sexes.
Clinically and medically stable.

Exclusion Criteria:

Patients who will meet one of the following criteria will be excluded from the study:

Only one functional eye.
Neurological problem or any severe co-morbidity likely to affect gait.
Intact visual field.
Instability of patient's medical condition.
Obese ( BMI ≥ 30 Kg∕m2 ).
Association with another medical problem that can affect patient

Sites / Locations

Beni Suef University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

study group

control group

Arm Description

20 patient with hemineglect, minimum 6 months post stroke

Outcomes

Primary Outcome Measures

gait changes in hemineglect patient after vestibulo ocular rehabilitation program

gait assesment using microsoft kinect for hemineglect patient pre and post vestibulo ocular rehabilitation

Secondary Outcome Measures

Full Information

NCT ID

NCT03913663

First Posted

April 9, 2019

Last Updated

July 23, 2019

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT03913663

Brief Title

Microsoft Kinect, Gait Function,Hemineglect, Vestibulo-ocular Training

Official Title

A Model Based Study for Gait in Heminglect Patient Pre and Post Vestibul-ocular Rehabilitation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

May 22, 2019 (Actual)

Primary Completion Date

July 15, 2019 (Actual)

Study Completion Date

July 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Gait problems in hemineglect patient post stroke , vestibuloocular training plays a role in improving gait function, gait assessment using a model based study (Microsoft Kinect) for pre and post training assesment.

Detailed Description

The syndrome of visuospatial neglect is a common consequence of unilateral brain injury. It is most often associated with stroke and is more severe and persistent following right hemisphere damage, with reported frequencies in the acute stage of up to 80%. This may result in gait disturbance, high levels of energy expenditure and increase the risk of falls. Vestibuleo-ocular training techniques are aimed at improving or even restoring visual function by training patients to detect stimuli in the blind hemifield and increase their overall sensitivity to them. The investigators propose a model based (Microsoft Kinect), a device can be used for assessment of spatiotemporal gait variables as well as gait kinematics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemiplegic Gait

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Active Comparator

Arm Description

20 patient with hemineglect, minimum 6 months post stroke

Arm Title

control group

Arm Type

Active Comparator

Arm Description

20 patient with hemineglect, minimum 6 months post stroke

Intervention Type

Other

Intervention Name(s)

vestibuloocular training

Other Intervention Name(s)

regular exercise training for hemiplegic patients

Intervention Description

using vestibulo ocular training program for training neglect patient

Intervention Type

Other

Intervention Name(s)

regular exercise training for hemiplegic patients

Intervention Description

Traditional gait training program.

Primary Outcome Measure Information:

Title

gait changes in hemineglect patient after vestibulo ocular rehabilitation program

Description

gait assesment using microsoft kinect for hemineglect patient pre and post vestibulo ocular rehabilitation

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects age will range from (60-70) years old. Patients who had a stroke at least six months prior. Patients who had visual field defects post stroke. Patients who could walk without caretaker assistance or no severe dyskinesias. Adequate hearing (hearing aid if required). Patients who had no problem with their state of consciousness and absence of dementia Patients who had no orthopedic problems that may affect gait. Patients will be chosen in both sexes. Clinically and medically stable. Exclusion Criteria: Patients who will meet one of the following criteria will be excluded from the study: Only one functional eye. Neurological problem or any severe co-morbidity likely to affect gait. Intact visual field. Instability of patient's medical condition. Obese ( BMI ≥ 30 Kg∕m2 ). Association with another medical problem that can affect patient

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

mohammed elhamrawy, master

Organizational Affiliation

Beni-Suef University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beni Suef University

City

Banī Suwayf

State/Province

Beni Suef

ZIP/Postal Code

62511

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

28767091

Citation

Gambi E, Agostinelli A, Belli A, Burattini L, Cippitelli E, Fioretti S, Pierleoni P, Ricciuti M, Sbrollini A, Spinsante S. Heart Rate Detection Using Microsoft Kinect: Validation and Comparison to Wearable Devices. Sensors (Basel). 2017 Aug 2;17(8):1776. doi: 10.3390/s17081776.

Results Reference

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PubMed Identifier

28980076

Citation

Basagni B, De Tanti A, Damora A, Abbruzzese L, Varalta V, Antonucci G, Bickerton WL, Smania N, Mancuso M. The assessment of hemineglect syndrome with cancellation tasks: a comparison between the Bells test and the Apples test. Neurol Sci. 2017 Dec;38(12):2171-2176. doi: 10.1007/s10072-017-3139-7. Epub 2017 Oct 4.

Results Reference

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PubMed Identifier

30251187

Citation

Muntaseer Mahfuz M, Schubert MC, Figtree WVC, Todd CJ, Migliaccio AA. Human Vestibulo-Ocular Reflex Adaptation Training: Time Beats Quantity. J Assoc Res Otolaryngol. 2018 Dec;19(6):729-739. doi: 10.1007/s10162-018-00689-w. Epub 2018 Sep 24.

Results Reference

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Learn more about this trial

Microsoft Kinect, Gait Function,Hemineglect, Vestibulo-ocular Training

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