- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03913663
Microsoft Kinect, Gait Function,Hemineglect, Vestibulo-ocular Training
July 23, 2019 updated by: Mohammed Youssef Elhamrawy, Beni-Suef University
A Model Based Study for Gait in Heminglect Patient Pre and Post Vestibul-ocular Rehabilitation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beni Suef
-
Banī Suwayf, Beni Suef, Egypt, 62511
- Beni Suef University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: study group
20 patient with hemineglect, minimum 6 months post stroke
|
using vestibulo ocular training program for training neglect patient
Other Names:
Traditional gait training program.
|
Active Comparator: control group
20 patient with hemineglect, minimum 6 months post stroke
|
Traditional gait training program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
gait changes in hemineglect patient after vestibulo ocular rehabilitation program
Time Frame: baseline
|
gait assesment using microsoft kinect for hemineglect patient pre and post vestibulo ocular rehabilitation
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: mohammed elhamrawy, master, Beni-Suef University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 22, 2019
Primary Completion (Actual)
July 15, 2019
Study Completion (Actual)
July 18, 2019
Study Registration Dates
First Submitted
April 9, 2019
First Submitted That Met QC Criteria
April 11, 2019
First Posted (Actual)
April 12, 2019
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- microsoft kinect hemineglect
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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