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.: PACTR202012851961769 Date of Approval: 04/12/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Overcoming Dual-task Interference for Functional Proficiency, Community Re-integration, Societal Participation and Return to Productivity After Stroke: A Randomized Controlled Study
Official scientific title Overcoming Dual-task Interference for Functional Proficiency, Community Re-integration, Societal Participation and Return to Productivity After Stroke: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial A large percentage of stroke survivors are discharged into the community with various degrees of disabilities which affect proficiency in the community and results in only few percentage stroke survivors being return back to work after stroke and become unproductive. This lack of return to productive life is not only due to lack of motor deficiency but also due to lack of performance of dual tasking activities efficiently; without which basic requirement in community re-integration is impossible. Clinical observation has shown instances in which stroke survivors can perform a cognitive task or a motor task in isolation, but during concurrent performance, one or both is severely impaired. The objective of the study is to investigate the efficacy of overcoming dual task interference on functional proficiency, community re-Integration, societal participation and return to productivity after stroke.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 21/12/2020
Actual trial start date
Anticipated date of last follow up 21/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Single Task training Twice a week for one hour Twelve weeks The 12-week single Task training (functional training program) will use progressive activities related to body stability (eg, standing with eyes closed, tandem standing and standing on a form with eye open), body stability plus hand manipulation (e.g. semi-tandem standing with rapid alternating hand movement, drawing letters with the affected limb and the unaffected limb and stand with narrow base of support and reaching in different direction), body transport (e.g. narrow walking, sit to stand and walk, and walk and trunk twist), and finally body transport plus hand manipulation (e.g. stand to sit and pick up an object from the floor). 50 Active-Treatment of Control Group
Experimental Group Dual task training Twice a week for one hour Twelve weeks Participants in group B will receive dual task exercise (functional training program and an additional task) under an instructional set (dual-task training under a Variable Priority instructional set, which implies that half of the training will be done with a focus on postural task performance, and half will focus on secondary task performance). The additional tasks are mostly cognitive task such as spell word backward, reciting a poem and count numbers backwards, tone discrimination, remembering of words and naming of words from given letters. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Hemiparetic from a single stroke occurring at most a year earlier. 2. Patients with stable medical condition. 3. Patients that are able to understand instructions and follow commands. (MMSE ≥ 25). 4. Patients that are able to maintain a stationary standing position with or without an assistive device for a minimum of 2 consecutive minutes without manual assistance. 5. Patients without any other neurological impairment such as Parkinson disease, spinal cord injury, Traumatic brain injury and muliple sclerosis 1. Any uncontrolled health condition for which exercise is contraindicated such as heart abnormalities. 2. Patient with any comorbidity or disability other than stroke that would preclude balance training such as amputation. 3. Severe uncontrolled visual impairment such as homonymous hemianopia. 4. Known vertigo patients or undergoing treatment for vestibular system dysfunction. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 65 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 10/09/2020 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 107,1st Floor LUTH Administrative Block Idi-Araba Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome DUAL-TASK EFFECTS Dual-task interference will be the primary outcome measure. Three different tasks of varying levels of difficulty (ie, simple, intermediate, advanced) will be used in the dual-task testing paradigm, namely, forward walking test, sit to stand and pick up an object from the floor, and an obstacle crossing test. For the forward walking test, participants walked along a 15-m walkway and time taken to walk the middle 10 m of the 15-m walkway will be measured For the sit to stand and pick up an object from the floor, participants sits on a chair stands and walks a 3 m, picks an object, turns walks back to the chair and sit down. The time to completion will be recorded by a stopwatch. For the obstacle crossing task, a 10-m walkway will be used and 10 obstacles (length 70 cm, width 4 cm, height 4 cm) will be placed 1 m apart from one another and time taken to walk the 10-m walkway will also be measured. For all 3 tests, participants will be instructed to complete the task as fast as possible while maintaining safety. A shorter walking time will indicate better functional proficiency. Two cognitive task domains, namely, verbal fluency and mental tracking, will be evaluated. For the verbal fluency task, participants will be asked to name any word start with letter A-J. For the mental tracking task, participants will be asked to performed serial-5-subtractions from a random number between 40 and 80. The number of correct answers generated will be recorded. The sequence of the 3 functional tests will be randomized first, followed by randomization of the sequence of the 2 cognitive tasks. Participants will start with one of the randomized functional tasks in the single-task condition, and then performs the same functional task in the dual-task condition (in conjunction with one of the cognitive tasks, in randomized sequence). Subsequently, the cognitive tasks will be performed in a sitting position (single-task condition). The time given to perform the cognitive task in single-task condition will be matched to the participant’s time taken to complete the cognitive task in the corresponding dual-task condition. The correct response rate (CRR) of the cognitive tasks will be calculated as follows: CRR = (number of correct responses ÷ time) ×100 Where a higher CRR value indicated better performance. When the tasks were performed in the dual-task condition, participants will be instructed to perform both tasks as well as possible. Participants will perform 1 practice trial of each task before data collection. Good reliability of the dual-task assessments has been established (Yang et al, 2016). The degree of dual-task interference will be represented by the percent dual-task effect (DTE %) of the functional time and CRR and will be calculated as follows (Plummber et al, 2013) : DTE% in functional time = (dual task functional time – single task functional time) × 100 Single task functional time DTE% in CRR = (dual task CRR – single task CRR) × 100 Single task CRR Therefore, a greater positive value for both variables will indicate greater performance deterioration under the dual-task condition compared with the single-task condition (ie, greater dual-task interference) (Plummer-D’Amato et al, 2012). Other assessment tools include: The Activities-specific Balance Confidence (ABC) Scale; Mini Mental State Examination scales; The Maleka Stroke Community Reintegration Measure; Participation Scale and Dynamic Gait Index. These assessments will be repeated at the end of the exercise protocol at the end of the twelveth week. The assessment will be done before and after the exercise protocol at the end of the twelveth week
Secondary Outcome DYNAMIC GAIT INDEX It includes 8 different gait tasks including walking on a level surface, walking while changing gait speeds, walking with vertical or horizontal head turns, walking with pivot turns, stepping over or around obstacles, and walking up and downstairs. Participants’ performance of each test item was rated on a 4-point scale (0−3), with the total score ranging between 0 and 24 (Marchetti et al, 2006) The assessment will be taken before and after the exercise protocol
Secondary Outcome THE ACTIVITIES-SPECIFIC BALANCE CONFIDENCE (ABC) SCALE It is designed to measure an individual’s confidence in his/her ability to perform daily activities without falling. It is an ordinal scale. The scale has 16 items (score 0-1600 possible). The score is recorded as a percentage (%), with 0% as the lowest level and 100% the highest level of confidence. Max score of 1600 divided by 16 items = 100% (Salbach et al, 2005) The assessment test will be done before and after the exercise protocol
Secondary Outcome MALEKA STROKE COMMUNITY REINTEGRATION MEASURE The Maleka Stroke Community Reintegration Measure (MSCRIM) will be used to assess community reintegration. It has an urban and rural version, but for the purpose of this study, the urban version will be used. This measure was found to be reliable and valid for stroke survivors in the urban townships of Johannesburg. The urban version has 40 items that are spread over the following six domains: ADLs and self-care, Social interaction and relationship, Home and family responsibilities, Social interaction, Extended family responsibilities and Work and education. The urban version of the MSCRIM is scored out of 112 by the researcher and converted to a percentage with a higher percentage score implying a higher level of community reintegration (Maleka, 2015). The MSCRIM is chosen because of its high reliability coefficient of 0.95 as well as its urban version’s relation to the reality of urban communities (Maleka 2015). It also has elements in it that relate directly to the social circumstances that were faced in the communities in the areas surrounding urban area such as Lagos city which is not found in other questionnaires such as attending traditional events and being able to collect water from a source outside of the participants dwelling. The assessment test will be done before and after the exercise protocol
Secondary Outcome PARTICIPATION SCALE It is an 18-item interview-based instrument that was designed to assess the participation of individuals with a health condition or disability. The scale was developed in an effort to better describe the participation of people living in middle-income and low-income countries. The items in the scale are closed, structured questions with Crohnbach's α of 0.92, intra-tester stability of 0.83 and inter-tester reliability of 0.80 (Wim t al, 2006; Souza et al, 2017). The assessment test will be done before and after the exercise protocol
Secondary Outcome MINI MENTAL STATE EXAMINATION SCALES It is a brief 30-point questionnaire test that is used to screen for cognitive impairment. It is also used to estimate the severity of cognitive impairment and to follow the course of cognitive changes in an individual over time, thus making it an effective way to document an individual's response to treatment. It examines functions including arithmetic, memory and orientation. The test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. Any score greater than or equal to 27 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10–18 points) or mild (19–24 points) cognitive impairment (Espino et al, 2004; Morales et al, 2006; Guerrero-Berroa et al, 2009) The assessment test will be done before and after the exercise protocol
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Ishaga Road, Idi-Araba, Lagos Surulere 100254 Nigeria
General Hospital Isolo 121, Mushin Road Oshodi-Isolo Lagos Lagos 100263 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Alade Taiwo Michael 50, Bodefapohunda street Ago Palace Way Okota Isolo Lagos 100263 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alade Taiwo Michael 50 Bodefapohunda street Ago Palace Way Okota Isolo Lago 100263 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Taiwo Alade tee4real11@yahoo.com +2348091816340 50, Bodefapohunda street Ago Palace Way Okota Isolo
City Postal code Country Position/Affiliation
Lagos 100263 Nigeria Senior Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Caleb Gbiri Calebgbiri@yaboo.com +2348033598072 College of Medicine, University of Lagos Idi-Araba
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Ayoola Aiyegbusi Bogphysio@yahoo.com 2348023212513 College of Medicine University of Lagos Idi-Araba
City Postal code Country Position/Affiliation
Lagos 100254 Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial after deidentification (text, tables, RCT figures, appendices) will be shared Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol One year Data will be analysed to achieve aims in the approved proposal Data will shared with anyone who wishes to access the 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