NCT03913663

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 22, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2019

Completed
Last Updated

July 24, 2019

Status Verified

May 1, 2019

Enrollment Period

2 months

First QC Date

April 9, 2019

Last Update Submit

July 23, 2019

Conditions

Hemiplegic Gait

Outcome Measures

Primary Outcomes (1)

  • gait changes in hemineglect patient after vestibulo ocular rehabilitation program

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

    baseline

Study Arms (2)

study group

ACTIVE COMPARATOR

20 patient with hemineglect, minimum 6 months post stroke

Other: vestibuloocular trainingOther: regular exercise training for hemiplegic patients

control group

ACTIVE COMPARATOR

20 patient with hemineglect, minimum 6 months post stroke

Other: regular exercise training for hemiplegic patients

Interventions

vestibuloocular trainingOTHER

using vestibulo ocular training program for training neglect patient

Also known as: regular exercise training for hemiplegic patients
study group
regular exercise training for hemiplegic patientsOTHER

Traditional gait training program.

control groupstudy group

Eligibility Criteria

Age60 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beni Suef University

Banī Suwayf, Beni Suweif Governorate, 62511, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 28767091BACKGROUND

  • 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.

    PMID: 28980076BACKGROUND

  • 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.

    PMID: 30251187BACKGROUND

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • mohammed elhamrawy, master

    Beni-Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 12, 2019

Study Start

May 22, 2019

Primary Completion

July 15, 2019

Study Completion

July 18, 2019

Last Updated

July 24, 2019

Record last verified: 2019-05

Locations

EG(1)