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.: PACTR202308481941633 Date of Approval: 28/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Structured Exercises and Music Therapy on the Functional Independence of Stroke Survivors in Rivers State
Official scientific title Effects of Structured Exercises and Music Therapy on the Functional Independence of Stroke Survivors: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Stroke is described as a brain injury which is caused by a sudden obstruction, interruption or even blockage of the blood supply to the brain (Gund, Jagtap, Ingale & Patil, 2013). It can lead to functional impairments in Activities of Daily Living (ADL) including mobility (Baumann et al., 2011).Many stroke survivors have a high prevalence of musculoskeletal problems resulting in functional limitations that are potentially modifiable with exercise (Ghasemi et al, 2018). Structured exercises are specific exercise regiments given to individual patients based on their health condition as at the time of assessment. It is therapeutic in nature and has a significant effect on the functional recovery of patients. Music therapy, on the other hand, is defined as the clinical and evidence based use of music interventions to accomplish individualized goals within a therapeutic relationship. There is national and regional paucity of literature relating to the effect of music therapy in combination with structured exercises on functional independence of stroke survivors. This study will fill the gap in literature, providing a more effective intervention in improving the functional independence of the stroke survivors in Rivers State, Nigeria, hence the need for this study. GENERAL OBJECTIVE: To determine if structured exercises combined with music therapy improves the functional independence of stroke survivors as compared to structured exercises alone. SPECIFIC OBJECTIVES: 1.To determine the functional independence of the stroke survivors at baseline before receiving structured exercises and music therapy. 2.To determine the functional independence of the stroke survivors after receiving structured exercises alone. 3.To determine the functional independence of the stroke survivors after receiving structured exercises combined with music therapy. 4. To establish a difference in the efficacy of structured exercises alone and structured exercises combined with music therapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 25/08/2023
Actual trial start date 05/02/2024
Anticipated date of last follow up 25/02/2024
Actual Last follow-up date 08/08/2024
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants) 86
Recruitment status Completed
Publication URL https://doi.org/10.55640/ijmsdh-10-12-07
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Structured Exercises combined with Music Therapy is the intervention arm. The structured exercises will be given two times a week at alternate days for one hour per treatment session. It will be the same for every participant. For the music therapy, it will include 30 minutes of receptive and relaxed listening of classical instrumental pieces via the headphone played on an android phone prior to the conventional treatment (structured exercises). The intervention will be given for a period of 6 months and then the stroke survivors will be re-assessed. Structured exercises include passive movement, free active exercises, resisted active exercises, proprioceptive neuro-muscular facilitation, auto-assisted exercises, weight bearing exercises, bridging exercises, bicycle ergo-meter exercises, treadmill exercises, balance training exercises, standing and walking re-education. Music Therapy includes receptive and relaxed listening of classical instrumental pieces via the headphone played on an android phone prior to the conventional treatment (structured exercises). . 43
Control Group Structured Exercises The structured exercises will be given two times a week at alternate days for one hour per treatment session. It will be the same for every participant. It will be given for a period of 6 months. Structured exercises include passive movement, free active exercises, resisted active exercises, proprioceptive neuro-muscular facilitation, auto-assisted exercises, weight bearing exercises, bridging exercises, bicycle ergo-meter exercises, treadmill exercises, balance training exercises, standing and walking re-education. 43 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male and female adults 18 years and above. 2. Being a stroke survivor for at least three months. Individuals too ill to participate 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 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 01/06/2023 University of Port Harcourt Research Ethics Committee. It is also known as Uniport Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
East-West Road Choba, Port Harcourt Port Harcourt PMB 5323 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Functional Independence of Stroke Survivors is the primary outcome. It is measured using the Functional Independence Measure (FIM). The FIM instrument quantitatively assesses the level of independence for performing a series of motor and cognitive tasks of daily living, according to the following items: self-care, transfers, walking, sphincter control, communication and social cognition, memory, social interaction and troubleshooting. Therefore, the instrument has two domains: The motor and cognitive components. The motor component includes self-care (6 items) sphincter control (2 items), transfers (3 items), and locomotion (2 items), while the cognitive component includes communication (2 items) and social cognition (3 items). Each item receives a score ranging from 1 to 7, and the complete score can vary from 18 to 126, indicating the functional status of the individual. 18 points correspond to total dependence - when the subject needs maximum or total help; 19 to 103 means moderate dependence - when the subject needs supervision or minimal help, while 104 to 126 means complete independence - absence of help from third parties. The outcome will first be measured at baseline and will later be measured again after six months of intervention.
Secondary Outcome The secondary outcomes for the study are hand grip strength, gait parameters and functional mobility of the stroke survivors. The gait parameters include step length, stride length, natural gait speed, maximum gait speed, and cadence. Hand grip strength of the stroke survivors is assessed using hand dynamometer while tape measure, stop watch and talcum powder are all used as materials to determine the gait parameters. Timed up and go test is used to determine the functional mobility of the stroke survivors. The secondary outcomes are assessed at baseline and after the period intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Port Harcourt Teaching Hospital Choba, Port Harcourt Port Harcourt Nigeria
Rivers State University Teaching Hospital Old G.R.A, Port Harcourt Port Harcourt Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded. No external funding for now Rumuekini Port Harcourt Port Harcourt Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self sponsored Rumuekini Port Harcourt Port Harcourt Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Sunday Chinenye University of Port Harcourt, Choba Port Harcourt Nigeria
Professor Blessing Jaja Rivers State University, Port Harcourt Port Harcourt Nigeria
Dr. Inumanye N. Ojule University of Port Harcourt, Choba Port Harcourt Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ifeanyi Oti oti_ifeanyi@uniport.edu.ng +2347030990911 School of Public Health, University of Port Harcourt
City Postal code Country Position/Affiliation
Port Harcourt Nigeria PhD Student of University of Port Harcourt School of Public Health
Role Name Email Phone Street address
Public Enquiries Ifeanyi Oti oti_ifeanyi@uniport.edu.ng +2347030990911 School of Public Health, University of Port Harcourt
City Postal code Country Position/Affiliation
Port Harcourt Nigeria PhD Student of University of Port Harcourt School of Public Health
Role Name Email Phone Street address
Scientific Enquiries Blessing Jaja jajabnr2000@yahoo.com +2348061916336 Rivers State University, Port Harcourt
City Postal code Country Position/Affiliation
Port Harcourt Nigeria Professor in Rivers State University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The study participants in this study are stroke survivors. The individual data sharing plan of the stroke survivors is as follows: 1. All the individual participants data collected during the trial will be made available. This will be after deidentification of the data. These data includes the socio-demographic characteristics of the participants such as age, sex, educational status etc. as well as the measured outcome variable e.g. the functional independence of the stroke survivors. 2. Other documents that will be made available include study protocol, Statistical Analysis Plan, Informed consent form, Clinical Study Report, and Analytic Code. Inform Consent Form There are two informed consent forms. The first consent form is the introductory letter stating the research topic, name of the researcher and the purpose of the study. This is to acquaint the participants with the purpose of the study, enabling them to make up their mind whether or not to participate in the study. The second consent form includes some basic agreement questions. It has boxes where the participants will tick which shows that they agree with the terms of the research study. Data Analysis Data will be analyzed using IBM SPSS version 25. Descriptive statistics will be calculated for all the variables and participant characteristics. Mean and standard deviations will be calculated for the functional independence measured pre and post intervention for both the groups. Baseline value will be measured and compared between the groups using Mann-Whitney U test. Post-intervention values of the variables will be measured and within group comparison would be made using Wilcoxon sign-rank test and between group comparison will be made using Mann Whitney U test. 3.The data will be made available to any researcher who wishes to access it for whatever purpose. This will be immediately following publication after the completion of the trial. 4. A link will be shared for data availability Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication after the completion of the trial, no end date Any researcher who wishes to access the data.That is the key access criteria.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://doi.org/10.55640/ijmsdh-10-12-07 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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/09/2023 The Trial has started Phase-0 Phase-1
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 09/11/2023 This is the actual stage of the trial. The process of determining the efficacy of structured exercises combined with music therapy on the functional independence of the stroke survivors is in progress. Phase-1 Phase-2
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 05/09/2023 The Trial actually started on 5th September, 2023 05 Sep 2023
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 21/12/2024 Study participants were available and ready for the trial 05 Sep 2023 05 Feb 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 21/12/2024 Trial was completed 08 Aug 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 21/12/2024 That was the number of eligible participants used in the study 86
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 05/09/2023 Recruitment has started Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 20/12/2024 The clinical trial has been successfully completed and results published Recruiting Completed
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Publication URL 20/12/2024 The link for the publication has been entered https://doi.org/10.55640/ijmsdh-10-12-07
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 09/11/2023 To add outcomes that can be monitored to help interpret the results of the primary outcome. They are measured both at baseline and after the period of interventions. Secondary Outcome, Predictors of Functional Independence in the study such as weight, Height, Body Mass Index etc. , The secondary outcome will be assessed at baseline before intervention Secondary Outcome, The secondary outcomes for the study are hand grip strength, gait parameters and functional mobility of the stroke survivors. The gait parameters include step length, stride length, natural gait speed, maximum gait speed, and cadence. Hand grip strength of the stroke survivors is assessed using hand dynamometer while tape measure, stop watch and talcum powder are all used as materials to determine the gait parameters. Timed up and go test is used to determine the functional mobility of the stroke survivors., The secondary outcomes are assessed at baseline and after the period intervention
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 17/08/2023 The previous letter was incomplete. Some information there were cut off. TRUE, University of Port Harcourt Research Ethics Committe, East-West Road Choba, Port Harcourt, Port Harcourt, PMB 5323, Nigeria, , 01 Jun 2023, +2348033360401, ethicscommitte@uniport.edu.ng, 25762_24674_4737.pdf TRUE, University of Port Harcourt Research Ethics Committe, East-West Road Choba, Port Harcourt, Port Harcourt, PMB 5323, Nigeria, , 01 Jun 2023, +2348033360401, ethicscommitte@uniport.edu.ng, 25762_24674_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 24/08/2023 The University of Port Harcourt Ethics Research committee is also referred to as Uniport Research Ethics Committee. Uniport is the abbreviated form of University of Port Harcourt. The website written on their ethics application form (ethicscommittee@uniport.edu.ng) is exactly what I submitted. This is what I know as far as the name of the ethical committee is concerned. TRUE, University of Port Harcourt Research Ethics Committe, East-West Road Choba, Port Harcourt, Port Harcourt, PMB 5323, Nigeria, , 01 Jun 2023, +2348033360401, ethicscommitte@uniport.edu.ng, 25762_24674_4737.pdf TRUE, University of Port Harcourt Research Ethics Committee. It is also known as Uniport Research Ethics Committee , East-West Road Choba, Port Harcourt, Port Harcourt, PMB 5323, Nigeria, , 01 Jun 2023, +2348033360401, ethicscommitte@uniport.edu.ng, 25762_24674_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 17/08/2023 Inclusion of the IPD sharing statement/plan that was not initially provided IPD includes socio-demographic characteristics of the stroke survivors and the measured outcomes of interest. The Individual Participant Data (IPD) Sharing Statement/Plan is as follows: 1. Will individual participant data be available (including data dictionaries)? YES 2. What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification 3. What other documents will be available? Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code 4. When will data be Immediately following publication after the available (start and end date)? completion of the trial, no end date 5. With who? Any researcher who wishes to access the data 6. For what types of analyses? Any purpose 7. By what mechanism will data be made The link for the data will be made available available?
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 24/08/2023 This is to give more details on the individual data sharing plan. The Individual Participant Data (IPD) Sharing Statement/Plan is as follows: 1. Will individual participant data be available (including data dictionaries)? YES 2. What data in particular will be shared? All of the individual participant data collected during the trial, after deidentification 3. What other documents will be available? Study Protocol, Statistical Analysis Plan, Informed Consent form, Clinical Study Report, Analytic Code 4. When will data be Immediately following publication after the available (start and end date)? completion of the trial, no end date 5. With who? Any researcher who wishes to access the data 6. For what types of analyses? Any purpose 7. By what mechanism will data be made The link for the data will be made available available? The study participants in this study are stroke survivors. The individual data sharing plan of the stroke survivors is as follows: 1. All the individual participants data collected during the trial will be made available. This will be after deidentification of the data. These data includes the socio-demographic characteristics of the participants such as age, sex, educational status etc. as well as the measured outcome variable e.g. the functional independence of the stroke survivors. 2. Other documents that will be made available include study protocol, Statistical Analysis Plan, Informed consent form, Clinical Study Report, and Analytic Code. Inform Consent Form There are two informed consent forms. The first consent form is the introductory letter stating the research topic, name of the researcher and the purpose of the study. This is to acquaint the participants with the purpose of the study, enabling them to make up their mind whether or not to participate in the study. The second consent form includes some basic agreement questions. It has boxes where the participants will tick which shows that they agree with the terms of the research study. Data Analysis Data will be analyzed using IBM SPSS version 25. Descriptive statistics will be calculated for all the variables and participant characteristics. Mean and standard deviations will be calculated for the functional independence measured pre and post intervention for both the groups. Baseline value will be measured and compared between the groups using Mann-Whitney U test. Post-intervention values of the variables will be measured and within group comparison would be made using Wilcoxon sign-rank test and between group comparison will be made using Mann Whitney U test. 3.The data will be made available to any researcher who wishes to access it for whatever purpose. This will be immediately following publication after the completion of the trial. 4. A link will be shared for data availability
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 17/08/2023 This is a more realistic time frame At the completion of the trial Immediately following publication after the completion of the trial, no end date
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 17/08/2023 To specify the key access criteria for anyone who wishes to access the data IPD will be made available on request to qualified researchers engaging in independent researchers. Any researcher who wishes to access the data.That is the key access criteria.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 21/12/2024 The link for the publication was made available https://doi.org/10.55640/ijmsdh-10-12-07
Section Name Field Name Date Reason Old Value Updated Value
Reporting Date of the first journal publication 21/12/2024 Date of first journal publication was entered 19 Dec 2024
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 17/08/2023 Inclusion of more document types that will be shared at the end of the trial Clinical Study Report Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code