Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201808158196289 Date of Approval: 02/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECTS OF VESTIBULAR REHABILITATION ON POSTURAL STABILITY IN ANTERIOR CIRCULATION STROKE PATIENTS: A RANDOMIZED CONTROLLED TRIAL
Official scientific title EFFECTS OF VESTIBULAR REHABILITATION ON POSTURAL STABILITY AND GAIT PERFORMANCE IN ANTERIOR CIRCULATION STROKE PATIENTS: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Anterior circulation strokes (ACS) are the most common of all ischemic strokes accounting for approximately 70% of all cases. A majority of the survivors after insult have a combination of sensory, motor, cognitive and emotional impairments leading to restrictions in their capacity to perform basic activities of daily living (ADL). Of all these possible sensorimotor deficits of stroke, the impaired postural control probably has the greatest impact on ADL independence and gait performance. Central vestibular disorder is a common after ACS mainly in middle cerebral artery territory due to lesion in Parieto- Insular Vestibular Cortex (PIVC). Such deficits in this region will cause typical vestibular symptoms in the form of postural instability and high risk of falling. Previous studies reported the effectiveness of vestibular rehabilitation (VR) on postural stability not only in older patients with chronic dizziness but also in healthy young adults. Surprisingly, management of central vestibular dysfunction are not integrated as a standard in rehabilitation program after anterior circulation stroke but occasionally treated as a separate problem. Furthermore, to our knowledge the effects of (VR) on postural stability in (ACS) patients is unknown.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ACS VR PIVC ADL
Disease(s) or condition(s) being studied Circulatory System,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/03/2019
Actual trial start date 06/02/2019
Anticipated date of last follow up 02/03/2020
Actual Last follow-up date 01/02/2021
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 36
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group conventional physical therapy program three times per week 6 weeks the control group will perform conventional physical therapy program only for 6 weeks which consists of : range-of-motion exercise for the upper, lower limbs and trunk, strengthening exercises, flexibility exercises, walking indoors and outdoors, and climbing up and down stairs. this program will be conducted for 60 min, 3 times per week for 6 weeks. 18 Active-Treatment of Control Group
Experimental Group vestibular rehabilitation program 3 times per week 6 weeks The experimental group will perform conventional intervention for 30 min in addition to vestibular rehabilitation for 30 min, as 60 min per session, 3 times per weeks for 6 weeks. The vestibular rehabilitation (VR) program consisted of two major components : Vestibular adaptation (Gaze stability exercises) and vestibular substitution exercises ( specific balance and upright postural control exercises) as follow : Regarding vestibular adaptation patients will be asked to focus on a target while moving head horizontally and still maintain fixation on the target then the same exercise will be repeated while moving the head vertically (VORx1). also patients will be asked to focus on a target while moving the target and the head in opposite directions horizontally and vertically while the patient keeps the target in focus by maintaining visual fixation on the target (VORx2). Each exercise for instance,will be performed for 1 minute without stopping. The time for each exercise can then be gradually increased to 2 minutes, the exercises will be progressed under more challenging and various functional conditions from sitting to standing with feet apart to feet together and during gait, walking with a different speed, against various backgrounds, during different distances and in different planes. Regarding Vestibular Substitution Exercises patients will be asked to maintain balance, while sitting upright, rotating of trunk to right and left, and weight shifting side to side and from standing with wide, narrow BOS , on firm and foam surface with eyes open and closed also while walking in all direction forward, sideways and backward, The progression and difficulty of exercises from one position to another will be according to patient's ability and response 18
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients diagnosed as anterior circulation stroke either Ischemic or hemorrhagic insult in MCA territory diagnosed by neurologist and confirmed by CT and or MRI. 2- First time stroke 3- Adults aged range from 43 to 69 yrs old. 4- Ability to stand unassisted for 30 seconds and ability to walk with or without support at least 30 m 5- Ability to communicate and understand instructions as indicated by a Mini-Mental Status Examination. 6- Mild to moderate balance impairment score of Berg Balance Scale [BBS] was ≥21 and ≤40according to a predictive cut off value which defined as the risk of “independent safe ambulation. 1- Infratentorial or post circulation stroke (brainstem or cerebellar, vertebrobasilar) 2- • patients with vestibular symptoms like vertigo or dizziness. 3- • Patients with other neurologic problems unrelated to stroke hemiparesis which can affect balance ability. 4- • Significant medical or psychiatric illness, motor apraxia and sensory aphasia. 5- • Lower limb orthopedic disorders, musculoskeletal complication like joint contracture that would affect the ability to walk safely or sever weight bearing pain. 6- • Patients who will not provide informed consent for study participation. Middle Aged: 45 Year(s)-64 Year(s) 43 Year(s) 69 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 03/09/2018 ethics committee faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed El- zayat - Ben El- sarayat Giza 12624 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/06/2018 faculty of physical therapy cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmd el zayat st giza 12624 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome postural stability considered the primary outcome which will be assessed using computerized dynamic posturography device SOT and Berg Balance scale at the base line before treatment and after 6 weeks. Base line before treatment and after 6 weeks .
Secondary Outcome Gait performance will be assessed also using The Timed Up-and-Go (TUG) before and after treatment as Secondary out come before and after 6 weeks of treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic faculty of physical therapy cairo university 7 ahmed El-zayat ben El- sarayat Giza 12624 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physicl therapy cairo university 7 ahmed El- Zayat Ben El- sarayat Giza 12624 Egypt University
COLLABORATORS
Name Street address City Postal code Country
vestibular and audiology unit kasr Al ainy Giza 11553 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Said Abd El Wahed Mohamed ahmed_neuro@yahoo.com 00201067706132 7 ahmed El- Zayat Ben El-Sarayat
City Postal code Country Position/Affiliation
Giza 12624 Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Wadida Hassan Abd El Kader dr.wadida.hassan@gmail.com 00201001097571 7 Ahmed El zayat Ben El Sarayat
City Postal code Country Position/Affiliation
Giza 12624 Egypt Professor faculty of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries Soheir Shehata Samaan soheirsamaan@hotmail.com 00201224003374 7 Ahmed El zayat Ben El sarayat
City Postal code Country Position/Affiliation
Giza 12624 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries ahmed ismail Abbas drahmedaudio@gmail.com 00201008706270 Al Hussein hospital - faculty of medicine Al azhar university
City Postal code Country Position/Affiliation
cairo 11663 Egypt Lecturer of Audio vestibular Medicine faculty of medicine Al azhar University
Role Name Email Phone Street address
Public Enquiries Ehab Shaker Belal ehabneuro@gmail.com 00201001465929 Kasr Al Ainy
City Postal code Country Position/Affiliation
Giza 11562 Egypt Professor of Neurology faculty of medicine Cairo university
REPORTING
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Undecided
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information