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.: PACTR202202919624090 Date of Approval: 03/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Osteoarthritis in Ghana: understanding patient’s needs and implementation of consequential intervention.
Official scientific title Effects of an African dance-based exercise program in patients with knee osteoarthritis: a randomized controlled trial
Brief summary describing the background and objectives of the trial Osteoarthritis (OA) is the leading cause of disability among adults worldwide. Patients with knee OA experience pain, joint stiffness and restricted movement. It has been reported that these patients have diverse perceptions about the disease that impact their functional abilities. Research suggests that better understanding of perceptions and expectations influences the outcome of interventions, positively. Most studies about clinical manifestations, perception of patients, diagnosis and treatment of knee OA have been conducted in high-income countries. OA affects multiple systems in the individual as well as in the environment. An intervention that will influence the various systems and in the long run optimize motor behaviour and function will be most beneficial. Dance therapy has been shown to have the capacity to improve both motor and cognitive functions among patients with chronic disease. The aim of this study is to evaluate the effects of an African dance-based intervention on the functional performance, balance, proprioception, muscle strength, cardiorespiratory capacity and physical activity of Ghanaian patients with knee OA after determining their clinical profiles and perceptions about the condition.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Dance Therapy
Anticipated trial start date 01/03/2022
Actual trial start date
Anticipated date of last follow up 30/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 56
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dance Therapy Two sessions in a week, each session lasting approximately 60min. 8 weeks Sessions will be organized as follows: a preliminary warm-up to music (about 5-10 minutes), followed by the teaching of a choreography of various African dance such as ‘kpanlogo’, ‘boboobo’, ‘azonto’, etc. These are African dances that utilize the concepts of polyrhythm and total body articulation. The session will finally end with the last 5-10min dedicated to free-style dancing. A new dance will be introduced each week with increasing difficulties. 28
Control Group Standard Care Two session in a week, each session lasting approximately one hour 8 weeks Standard physiotherapy: Electrotherapy (TENS), soft tissue manipulation, knee strengthening exercises 28 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients diagnosed with knee OA by the Orthopaedic Surgeon. Ghanaian patients attending the Physiotherapy clinic. Aged 40 years and above. Presence of other forms of arthritis (e.g. rheumatoid arthritis). Presence of pathologies in the region of the lower extremities or lower back that are not related to OA and need medical treatment. Inability to ambulate even with a walking aid (as this will deprive them from partaking in the performance-based tests). Patients who have undergone hip or knee replacement surgeries in both limbs (Patients whose symptomatic limb is yet to be operated upon but have a previous surgery done on the other limb will however be included). Patients with any neurological and cardiovascular disease that may preclude assessment procedures. Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 70 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 13/01/2022 37 Military hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Liberation Road Accra 37 Ghana
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 29/11/2021 Korle Bu Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Guggisberg Avenue Accra Box KB 77 Ghana
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 19/08/2021 University of Cape Town Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Rm G50- Old Main Building Cape Town X3 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome functional performance assessed with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), pre-intervention, post-intervention/immediately after 8-week intervention, post-intervention/ after 3 months
Secondary Outcome Static-dynamic balance: this will be measured using the following scales: Y-balance for the lower quarter (LQYBT) and the Timed UP and Go test (TUG). The LQYBT is a tool used to measure a person’s balance and also test their risk for injury. The TUG test is used to measure the progress of balance as well as to determine fall risk. pre-intervention, post-intervention/immediately after 8-week intervention, post-intervention/ after 3 months
Secondary Outcome Proprioception: Wedges of various heights will be used to judge heel height discrimination. To judge the minimal perceptual difference in estimated heel height the participants presumably will rely on a combination of sensory inputs. pre-intervention, post-intervention/immediately after 8-week intervention, post-intervention/ after 3 months
Secondary Outcome Muscle strength: Isometric muscle strength will be measured with a hand-held dynamometer pre-intervention, post-intervention/immediately after 8-week intervention, post-intervention/ after 3 months
Secondary Outcome Cardiorespiratory Capacity: this will be evaluated with the 6-Minute Walk Test. pre-intervention, post-intervention/immediately after 8-week intervention, post-intervention/ after 3 months
Secondary Outcome Physical activity: A pedometer will be fastened to the sides of the belts of participants. pre-intervention, post-intervention/immediately after 8-week intervention, post-intervention/ after 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital Guggisberg Ave Accra Box KB 77 Ghana
37 Military Hospital Liberation Road Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded E9a Atomic Hills, Ashongman Estates Accra CT 7360 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self E9a Atomic Hills, Ashongman Estates, Accra Accra CT 7360 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samuel Otoo wieotoo@yahoo.com +233546227458 E9a Atomic Hills, Ashongman Estates
City Postal code Country Position/Affiliation
Accra CT7360 Ghana Senior Physiotherapist. NMC
Role Name Email Phone Street address
Public Enquiries Samuel Otoo wieotoo@yahoo.com +233546227458 E9a Atomic Hills Estates, Ashongman Estates
City Postal code Country Position/Affiliation
Accra CT7360 Ghana Senior Physiotherapist. NMC
Role Name Email Phone Street address
Scientific Enquiries Niri Naidoo niri.naidoo@uct.ac.za +27214066314 Faculty of Health Science, UCT
City Postal code Country Position/Affiliation
Cape Town South Africa Senior Lecturer. UCT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results from data collection (de identified) Study Protocol 2 years Access request will not be controlled. There shall be no restrictions on the kind of request made. The PI will consider the requests that come in based on their merit.
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