Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201806003363142 Date of Registration: 02/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Comparison Between Two Different Protocols of Lower Limb Constraint Induced Movement Therapy in Post-stroke Patients
Official scientific title A Comparison Between Two Different Protocols of Lower Limb Constraint Induced Movement Therapy in Post-stroke Patients
Brief summary describing the background and objectives of the trial Constraint induced movement therapy (CIMT) is a motor rehabilitation technique that is used mainly for the upper limb after stroke. Recently, there is increasing interests on its application in lower limbs. The objective of this study is to determine the comparative effects of two different protocols of CIMT.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Musculoskeletal Diseases,Nervous System Diseases,Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 09/05/2018
Actual trial start date 16/05/2018
Anticipated date of last follow up 27/06/2018
Actual Last follow-up date 04/07/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 58
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MOH/Off/797/T.I/688
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 A research assistants who is blinded to the aim of the study will write the numbers, 1 and 2 equally on 58 opaque pieces of paper which will be folded. Then, each of the participants will be asked to pick one piece of the paper and submit to the research assistant without opening it. He will be blinded to the aim of the study Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 600 repetitions of tasks CIMT 600 repetitions backward, side, forward stepping, ball kicking and stair climbing each 40 times per session 3 times a day for 4 weeks. 29
Control Group Hours of task practice 3 hours of task practice, 5 times a week for 4 weeks Backward, side, forward stepping, ball kicking and stair climbing 29 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria: The study will include patients diagnosed with unilateral stroke that have asymmetrical stance, patients with ability to stand and walk with minimal assistance, no significant mental impairment indicated by a mini mInclusion criteria: The study will include patients diagnosed with unilateral stroke that have asymmetrical stance, patients with ability to stand and walk with minimal assistance, no significant cognitive impairment indicated by a mini mental state score of ¿24 on mini mental state examination (MMSE), patients must have at least 15 degrees of knee flexion in the affected limb and aged 18 years and above. Patients with heart or lung diseases which make it difficult or risky to participate in intensive training such as Unstable angina, uncontrolled-abnormal heart rhythms, severe aortic stenosis, symptomatic heart failure and suspected or known dissecting aneurysm, pulmonary infarction, severe shortness of breath, inflammation or infection in the heart or any other systemic infection as stated by the American college of sports medicine, patients with severe pain that may interfere with training and patients with hemi neglect demonstrated by a cutoff of <44 on the star cancellation test will be excluded from the study. 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 11/04/2018 Health Research Ethics Committee of the Ministry of Health, Kano
Ethics Committee Address
Street address City Postal code Country
Kano state of Nigeria, Ministry of Health, 2nd and 3rd floor, post office road. PMB 3066, Kano Kano 700001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lower limb motor activity baseline, 2 weeks and 4 weeks
Primary Outcome gait and balance baseline, 2 weeks and 4 weeks
Secondary Outcome Endurance and gait speed baseline, 2 weeks and 4 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Muhammad Hospital Kofar Mata road, Kano kano 700001 Nigeria
Muhammad Abdullahi Wase Specialist Hospital Hospital Road Kano kano 700001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Naima Aliyu Umar no. 597 Ibrahim Zaki Road, kano. kano 700001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Naima Aliyu Umar No. 597 Ibrahim Zaki Road, BUK new site. kano 700001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Auwal Abdullahi PMB 3011, Gwarzo Road Kano kano 700001 Nigeria
Naima Aliyu Umar No. 597 Ibrahim Zaki Road, BUK new site. kano 700001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Naima Umar nallee33@gmail.com +2348131866889 no. 597 ibrahim Zaki Road, BUK New Site.
City Postal code Country Position/Affiliation
kano 700001 Nigeria Muhammad Abdullahi Wase Specialist Hospital Kano/ Department of Physiotherapy BUK
Role Name Email Phone Street address
Public Enquiries Naima Umar nallee33@gmail.com +2348131866889 no. 597 ibrahim Zaki Road, BUK New Site.
City Postal code Country Position/Affiliation
kano 700001 Nigeria Muhammad Abdullahi Wase Specialist Hospital Kano/ Department of Physiotherapy BUK
Role Name Email Phone Street address
Scientific Enquiries Auwal Abdullahi aabdullahi.pth@buk.edu.ng +2347035267375 PMB 3011 Gwarzo road, Kano
City Postal code Country Position/Affiliation
kano 700001 Nigeria Lecturer/ Department of physiotherapy, Bayero University Kano
REPORTING
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