Hemiplegic GaitNCT03913663
Microsoft Kinect, Gait Function,Hemineglect, Vestibulo-ocular Training
A study testing vestibuloocular training and regular exercise training for hemiplegic patients in people with Hemiplegic Gait, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Hemiplegic Gait
- What is being tested?
- vestibuloocular training and regular exercise training for hemiplegic patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 22 May 2019to 18 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patients who had no orthopedic problems that may affect gait.
- Patients will be chosen in both sexes.
- Clinically and medically stable.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemiplegic Gait
- Being tested
- vestibuloocular training, regular exercise training for hemiplegic patients
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibuloocular trainingOther
Also called regular exercise training for hemiplegic patients
using vestibulo ocular training program for training neglect patient
regular exercise training for hemiplegic patientsOther
Traditional gait training program.
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | 20 patient with hemineglect, minimum 6 months post stroke Receives: Other: vestibuloocular training; Other: regular exercise training for hemiplegic patients |
| control group | Active comparator | 20 patient with hemineglect, minimum 6 months post stroke Receives: Other: regular exercise training for hemiplegic patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait changes in hemineglect patient after vestibulo ocular rehabilitation program
gait assesment using microsoft kinect for hemineglect patient pre and post vestibulo ocular rehabilitation
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start22 May 2019
- Primary completion15 Jul 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Youssef Elhamrawy, Beni-Suef University
- Investigators
- mohammed elhamrawy, master, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913663
- Sponsor's protocol ID
- microsoft kinect hemineglect
- Status last verified
- May 2019
- First submitted
- 9 Apr 2019
- Last updated
- 24 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28767091Basagni 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.
PubMed 28980076Muntaseer 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.
PubMed 30251187
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Model Based Study for Gait in Heminglect Patient Pre and Post Vestibul-ocular Rehabilitation
- ClinicalTrials.gov ID
- NCT03913663
- Acronym / sponsor ID
- microsoft kinect hemineglect
- Conditions
- Hemiplegic Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Other: vestibuloocular training, Other: regular exercise training for hemiplegic patients20 patient with hemineglect, minimum 6 months post stroke |
| control group | Active comparator | Other: regular exercise training for hemiplegic patients20 patient with hemineglect, minimum 6 months post stroke |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (7 listed)
- 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 ).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vestibuloocular trainingAlso: regular exercise training for hemiplegic patientsusing vestibulo ocular training program for training neglect patient | Other | study group |
| regular exercise training for hemiplegic patientsTraditional gait training program. | Other | control group, study group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Background: PubMed 28767091Gambi 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.
- Background: PubMed 28980076Basagni 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.
- Background: PubMed 30251187Muntaseer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohammed elhamrawy, master principal investigator
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibuloocular training and regular exercise training for hemiplegic patients in people with Hemiplegic Gait, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait changes in hemineglect patient after vestibulo ocular rehabilitation program (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03913663, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019; AzTrials last refreshed its copy on 31 Oct 2026.