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.: PACTR201903732473573 Date of Approval: 11/03/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Prism Adaptation Therapy on Unilateral Spatial Neglect of Patients with Stroke in Sub-Acute Phase of recovery.
Official scientific title Effect of Prism Adaptation Therapy on Unilateral Spatial Neglect of Patients with Stroke in Sub-Acute Phase of recovery
Brief summary describing the background and objectives of the trial Among stroke associated impairments that result in clinical deficit, the presence of unilateral spatial neglect has been consistently associated with slower functional progress during rehabilitation, reduced ability to function in ADLs (most especially the self-care activities), a greater risk for falls, poor functional recovery, reduced health related Quality of Life (QoL) and all these result in increased costs for health care systems (Paolucci et al, 2001; Di Monaco et al, 2011; Hamzat et al, 2012; Choi et al, 2013; Gbiri et al, 2014 ). Despite the frequency and negative impact of unilateral neglect on rehabilitation outcome of stroke survivors, very few studies on rehabilitative interventions aimed at improving visual neglect has been conducted (Nys et al, 2008; Turton et al, 2010). Efficient ehabilitation of unilateral spatial neglect in stroke patients is imperative albeit elusive with insufficient evidence to support or refute the effectiveness of current treatment approaches at reducing disability (Bowen and Lincoln, 2007) hence the need for evidence-based and empirically supported approach in rehabilitation of unilateral spatial neglect. Benefits of prism adaptation in the treatment of USN have some question still unanswered. Primary Objective: To establish the effect of prism adaptation therapy on Unilateral Spatial Neglect in stroke survivors at the sub-acute phase of recovery. Secondary Objectives: To identify demographic and clinical profile characteristics (Age, gender, educational level, Stroke duration, type of stroke, side of stroke, handedness) of stroke survivor which are predictive of prism adaptation therapy effect on unilateral spatial neglect in stroke survivors in the sub-acute
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 04/03/2019
Actual trial start date
Anticipated date of last follow up 04/04/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants)
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group prism adaptation therapy twelve sessions of prism adaptation therap over 4 weeks Reaching Task The prism adaptation intervention procedure for reaching task will be adapted from a similar study by Mizuno et al in 2011.patients recruited for this study will sit at a desk on which a wooden table (height 30 cm) will be placed. The top of the table will have semicircular shape with a radius of 60 cm, and 3 targets will be marked at the center, right, and left corners of its edge. Patients will sit vertically during each session, with assistance if necessary. The distance between each patient and the targets will be adjusted for the patient’s arm length. Patients will be asked to point to the 3 targets through the bottom of the table with the index finger of the ipsilesional hand, according to the instructions of the therapists, who will randomly indicate 3 points to the patients. The reaching trajectories will be hidden by the table. Patients would be able to see their own finger only at the edge of the table. Patients will be asked to reach and bring back their hand as quickly as possible without correction of pointing error. First, they will repeat the pointing task 30 times without prism glasses. Then, they will put on prism glasses that will shift their visual field 10° to the right (deluxe Prism google; (Bernel 1138KIT28+) and will repeat pointing 90 times. After pointing at targets, the prism glass will be taken off and will repeat pointing 60 times. Patients will undergo daily training sessions for about 30 minutes each, 3 times a week for 4 weeks, for a total of 12 sessions. The interventions will take place during regularly scheduled rehabilitation sessions; all other routine interdisciplinary stroke rehabilitation will be provided as usual. The control and intervention group will undergo the same intervention procedure. However, the control group will utilize a neutral googles whilst the intervention group utilizes prism glass. 1.2 Stepping task The stepping task will be adapted from a related previous study by Nemanich & Earhart in 2015 42
Control Group placebo same as intervention group conventional Physiotherapy for stroke rehab + neutral goggles for prism adaptation therapy 42 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
I. First-ever hemiparetic stroke, II. Admission within 3 months after stroke onset III. Age 18 years and above. IV. No severe cognitive impairment (Mini-Mental State Examination score>17). I. Inability to sit on a wheelchair. II. Inability to comprehend task because of aphasia or other cognitive impairment. III. Extremely impaired eyesight. IV. Severe hearing loss. V. Inability to reach with the upper extremity because of restricted range of motion VI. Amputation of the ipsilessional upper extremity 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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 12/07/2018 Human Research ethics committee Medical University of Witwatersrand
Ethics Committee Address
Street address City Postal code Country
29 Princess of Wales Terrace, Parktown. Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome unilateral spatial neglect measured assessed using the behavioural inattention test baseline and post intervention
Secondary Outcome FUNCTIONAL ABILITY measured 4. Barthel Index (BI) The Barthel Index (BI) measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. T pre and post intervention
Secondary Outcome Gait abilities Measured using Zebris FDM-T System for stance and gait analysis, Berg balance scale the Berg Balance Scale (BBS) quantitatively assesses balance in older adults . Modified Rivermead Mobility Index (MRMI). pre and post intervention
Secondary Outcome Quality of Life measured using Stroke Specific QOL (SSQOL questionnaire) pre and post intervention
Secondary Outcome balance abilities measured using the berg balance scale and the. Modified Rivermead Mobility Index (MRMI)valuate the effectiveness of physiotherapy on mobility following stroke. pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwaneth Academic Hospital Bara Johannesburg 2090 South Africa
Charlotte Maxeke Johannesburg Academic Hospital York Road Parktown Johannesburg 2092 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Health Science research grant 2 Jan Smut AVenue Johannesburg 2090 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof. Veronica Ntsiea department of physiotherapy, Wits University johannesbgurg 2090 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof Veronica Ntsiea 7 york street, PARKTOWN park town Johannesburg 2092 South Africa
Dr Ronel Roos 7 york street, PARKTOWN park town Johannesburg 2092 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chuka Umeonwuka chuquespt@unimaid.edu.ng +27605535722 277 Marshal street
City Postal code Country Position/Affiliation
Johannesburg 2090 South Africa Doctoral Fellow
Role Name Email Phone Street address
Public Enquiries Veronica Ntsiea Veronica.Ntsiea@wits.ac.za +27832972146 department of physiotherapy, Wits
City Postal code Country Position/Affiliation
Johannesburg 2092 South Africa Associate professor supervisor
Role Name Email Phone Street address
Scientific Enquiries Ronel Roos Ronel.Roos@wits.ac.za +277060973458 7 York street Parktown
City Postal code Country Position/Affiliation
Johannesburg 2090 South Africa senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes participant data will be kept annonymous. only principal investigator and research collaborators will have access to data. Participant's pooled result will be shared via academic publication in peer reviewed journal hence keeping individual participant data annonymous Study Protocol 12 months within study controlled acces; only collaborators and principal investigator will have access to data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information