Trial no.:	PACTR201509001223262	Date of Approval:	03/08/2015
Trial Status:	Registered in accordance with WHO and ICMJE standards

TRIAL DESCRIPTION

Public title

THE PREVALENCE AND MANAGEMENT OF VISUAL IMPAIRMENTS AND VESTIBULAR DYSFUNCTION IN POST-STROKE PATIENTS IN THE SUB-ACUTE PHASE

Official scientific title

THE PREVALENCE AND MANAGEMENT OF VISUAL IMPAIRMENTS AND VESTIBULAR DYSFUNCTION IN POST-STROKE PATIENTS IN THE SUB-ACUTE PHASE

Brief summary describing the background and objectives of the trial

Insufficient evidence on the prevalence of (a) visual impairments; and (b) central vestibular dysfunction in patients post-stroke has been identified in the literature. The researcher therefore identified a need to investigate the prevalence of visual impairments and central vestibular dysfunction in the sub-acute stroke population. Even though the association between visual impairments, vestibular dysfunction and disability in activities of daily living is well established; the services available to patients with visual impairments and vestibular dysfunction following stroke are inconsistent at present. Identification of possible presence of visual impairments and central vestibular dysfunction in the post-stroke population may facilitate the development of evidence-based treatment for patients with visual impairment and central vestibular dysfunction following stroke. A further limitation on the combination of vestibular rehabilitation therapy (VRT) and visual scanning exercises (VSE) as part of, and integrated with, physiotherapy has been identified in the literature. There is a need for research evidence on the combination of VRT and VSE as part of, and integrated with task-specific activities (the gold standard in post-stroke rehabilitation), to determine the effect of the intervention on body impairment level, functional activity and participation levels in the treatment of post-stroke patients. The long-term effect of VSE and VPT integrated with task-specific activities (the gold standard in post-stroke rehabilitation) on patients¿ activities related to participation also has to be investigated. The main aim of phase 1 is to determine the prevalence of visual impairments and central vestibular dysfunction post-stroke. The main aim of phase 2 is to determine the effect of task-specific activities as an intervention compared to the effect of the combination of VRT and VSE integrated with task-specific activities as an intervention post-stroke.

Type of trial

CCT

Acronym (If the trial has an acronym then please provide)

Disease(s) or condition(s) being studied

Musculoskeletal Diseases,Nervous System Diseases,Stroke

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Treatment: Other

Anticipated trial start date

01/09/2015

Actual trial start date

01/09/2015

Anticipated date of last follow up

31/08/2016

Actual Last follow-up date

31/08/2016

Anticipated target sample size (number of participants)

60

Actual target sample size (number of participants)

60

Recruitment status

Not yet recruiting

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
Parallel: different groups receive different interventions at same time during study	Non-randomised			Masking/blinding used	Outcome Assessors,Participants

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	Combination of VRT and VSE integrated with task-specific activities.	Patients will receive intervention for one hour daily for a period of two (2) weeks.	Patients will receive intervention for one hour daily for a period of two (2) weeks.	Vestibular rehabilitation therapy (VRT) for treatment of central vestibular dysfunction consists of a programme of exercises designed to; (i) facilitate adaptation of the vestibular system; (ii) habituate the person to movement; (iii) teach sensory substitution; and (iv) improve a person¿s balance and postural control (Alghadir et al, 2013).	30
Control Group	Task-specific activities alone as an intervention approach	Patients will receive intervention for one hour daily for a period of two (2) weeks.	Patients will receive intervention for one hour daily for a period of two (2) weeks.	The task-specific approach to rehabilitation is the intervention approach of choice (standard of care) that is described as fundamental to the Motor Learning approach as well as the Neuro-developmental approach to rehabilitation (Shumway-Cook & Woollacott, 2007).	30

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
a) Patients that suffered either an ischaemic or haemorrhagic stroke (Blanton et al, 2006) as clinically diagnosed by a medical specialist. Information on type of stroke will be obtained from the patients¿ medical records. b) Male and female patients from the age group 19 ¿ 84 years (The SASPI Project Team, 2004). c) Patients that are in the sub-acute phase following the stroke, are able to follow instructions (Lennon et al, 2006) and have the capacity to provide informed consent (Loetscher et al, 2015). d) Patients that presented with visual impairments and central vestibular dysfunction identified during phase 1 of the study will be recruited to participate in phase 2 of the study.	a) Severe dementia, identified by implementing the Mini-Mental State Examination (MMSE). (Patients must have a score of seven or higher on the MMSE) (Hafsteinsdóttir, 2005). b) History of an organic disorder or major psychiatric impairment (Blanton et al, 2006). c) Other co-morbid disease or disability such as cancer or amputation that will prevent or limit assessment of the patients and their, participation or follow-up over a period of twenty (20) weeks (Robertson et al, 2002; Blanton et al, 2006; Lennon et al, 2006). d) Positive Dix-Hallpike test (to exclude BPPV). e) Dix-Hallpike test: Because the Dix-Hallpike test and CRT (Epley) manoeuvre require head rotation of 45° and extension of 20° to 30°; patients with a history of neck surgery, recent neck trauma, severe rheumatoid arthritis, atlanto-axial and occipito-atlantal instability, cervical myelopathy or radiculopathy, carotid sinus syncope, Chiari malformation and vascular dissection syndromes are excluded from the study (Herdman & Tusa, 2007). f) Participation in other pharmacological or rehabilitation intervention studies which can lead to confounding of the results of this study (Blanton et al, 2006). g) Any adverse effects within the period of twenty (20) weeks will be documented.		19 Year(s)	84 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

Yes

26/08/2015

The Research Ethics Committee, Faculty Health Sciences, University of Pretoria

Ethics Committee Address
Street address	City	Postal code	Country
31 Bophelo Road, HW Snyman South Building, Level 2, Room 2.33	Pretoria		South Africa

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	Functional ability	Baseline After the two (2) weeks intervention period.
Secondary Outcome	Visual impairments	Baseline After the two (2) weeks intervention period
Secondary Outcome	Central vestibular dysfunction	Baseline After the two (2) weeks intervention period
Secondary Outcome	Cognitive function	Baseline After the two (2) weeks intervention period
Secondary Outcome	Visual-perceptual function	Baseline After the two (2) weeks intervention period
Secondary Outcome	Residual oculomotor visual performance	Baseline After the two (2) weeks intervention period
Secondary Outcome	Functional balance	Baseline After the two (2) weeks intervention period
Secondary Outcome	Ability to modify gait in response to changing task demands	Baseline After the two (2) weeks intervention period
Secondary Outcome	Level of anxiety and/or depression	Baseline After the two (2) weeks intervention period
Secondary Outcome	Participation in physical activity	Twenty (20) weeks after rehabilitation has been terminated.

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Rehabilitation hospital settings		Pretoria		South Africa
Rehabilitation hospital settings		Johannesburg		South Africa

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Life New Kensington Clinic	23 Roberts Avenue	Johannesburg	2101	South Africa

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Primary Sponsor	University of Pretoria	Cnr Lynnwood Road and Roper Street	Pretoria		South Africa	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Department of Audiology, Faculty of Humanities, University of Pretoria	Cnr Lynnwood Road and Roper Street	Pretoria		South Africa

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Andoret van Wyk	andoret@mweb.co.za	0827111774	23 Embassy Crescent, Waterkloofvallei, 14 Squirel Street, Monumentpark
City	Postal code	Country	Position/Affiliation
Pretoria	0105	South Africa	University of Pretoria
Role	Name	Email	Phone	Street address
Public Enquiries	Andoret van Wyk	andoret@mweb.co.za	0827111774	23 Embassy Crescent, Waterkloofvallei, 14 Squirel Street, Monumentpark
City	Postal code	Country	Position/Affiliation
Pretoria	0105	South Africa	University of Pretoria
Role	Name	Email	Phone	Street address
Scientific Enquiries	Andoret van Wyk	andoret@mweb.co.za	0827111774	23 Embassy Crescent, Waterkloofvallei, 14 Squirel Street, Monumentpark
City	Postal code	Country	Position/Affiliation
Pretoria	0105	South Africa	University of Pretoria

REPORTING
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