Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201610001828172 Date of Approval: 18/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of Number of Repetition and Hours of Shaping Practice during Constraint Induced Movement Therapy Following Stroke: A Randomized Controll
Official scientific title Effectiveness of Number of Repetition and Hours of Shaping Practice during Constraint Induced Movement Therapy Following Stroke: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Constraint induced movement therapy (CIMT) for the upper limb rehabilitation following stroke has a very strong theoretical evidence base (Wolf et al., 2006; Sirtori et al., 2009; Nijland et al., 2011). However, despite this evidence, its protocol differs remarkably among clinicians and researchers, and this may limit its clinical usability since clinicians may not be certain on which one to use or not. In the literature, some may use 6 hours and others less of shaping and task practice with varied periods of constraint (Sirtori et al., 2009; Nijland et al., 2011). When hours of shaping and task practice and constraint are used, how much shaping or task that is practiced may not be very clear. Consequently, researchers have argued that the use of number of shaping practiced could make a suitable alternative for the existing CIMT protocols (Birkinmeier et al., 2010; Abdullahi et al., 2014). They reasoned that, the new protocol is simple and thus motivational and can be monitored even by the patients themselves. Few studies have already elucidated the feasibility of this new protocol. The aim of the present study is to compare the use of hours of shaping practice and the number of repetitions of shaping practice as protocols of CIMT.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 18/11/2016
Actual trial start date 18/12/2016
Anticipated date of last follow up 18/03/2017
Actual Last follow-up date 30/05/2017
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants) 76
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
MOH/Off/797/T.I/176 Kano State Ministry of Health
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 Random sampling using random number generation The assistant wrote numbers from 1 to 76 on opaque papers, fold them and use simple random sample to select 4 Physiotherapists who will randomly pick 10 numbers each. The therapists will be blinded of the purpose of the selection Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group D 600 repetitions of shaping practice with constraint of the unaffected limb for 90% of the waking hours 5 days a weeks for 4 weeks shaping practice such as picking up a cup from the table and drinking from it and writing 19
Control Group Group A hours of traditional therapy 5 times a week for 4 weeks Traditional therapy=passive movement, therapeutic positioning and weight bearing on the affected limb. 19
Experimental Group Group B 3 hours of shaping practice with constaraint of the unaffected limb for 90% of the waking hours 5 days a week for 4 weeks shaping practice such as picking up a cup from the table and drinking from it and writing 19
Experimental Group Group C 300 repetitions of shaping practice with constraint of the unaffected limb for 90% of the waking hours 5 days a week for 4 weeks shaping practice such as picking up a cup from the table and drinking from it and writing 19
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
acute stroke (¿ 4 weeks post stroke) with unilateral stroke, persistent hemiparesis (a score of 1-3) on the motor arm item of the NIH Stroke Scale with proximal upper extremity voluntary activity (a score of ¿3) on the upper arm item of the Motor Assessment Scale, no significant impairment in cognitive function (a score of ¿1 on the consciousness and communication items of the NIHSS, ability to perform two-steps commands and a score of <8 on the Short Blessed Memory Orientation and Concentration Scale) and no upper extremity injury that limited use prior to the stroke. Hemispatial neglect as determined by asymmetry >3 errors on the Star Cancellation Test and sensory loss ¿2 on the sensory item of NIHSS. Similar criteria were used in a constraint induced movement therapy study previously. 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 10/10/2016 Ethis Sub-committee of Operational Research Advisory committe, Kano State Ministry of Health, Nigeria
Ethics Committee Address
Street address City Postal code Country
Post office road Kano 700001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Wolf motor function test Baseline, 2 week, 4 weeks and 3 months
Primary Outcome Motor Activity Log Baseline, 2 weeks, 4 weeks and 3 months
Primary Outcome Upper Limb Fugl Meyer Baseline, 2 weeks, 4 weeks and 3 months
Primary Outcome Upper Limb Self-efficacy Test Baseline, 2 weeks, 4 weeks and 3 months
Secondary Outcome Modified Ashworth Scale Baseline, 2 weeks, 4 weeks and 3 months
Secondary Outcome Subjective Motor Assessment and Registration of Task (SMART) Baseline, 2 weeks, 4 weeks and 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala Mohammed Specialists Hospital, Kano Kofar Mata road Kano 700001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Department of Physiotherapy, Bayero University Kano Kano 700001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bayero University Kano Department of Physiotherapy, Bayero University Kano Kano 700001 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Murtala Muhammad Specialists Hospital, Kano Kofar Mata Road Kano 700001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Auwal Abdullahi therapistauwal@yahoo.com +2347035267375 Department of Physiotherapy, Bayero University Kano
City Postal code Country Position/Affiliation
Kano 700001 Nigeria Lecturer/ Bayero University kano
Role Name Email Phone Street address
Public Enquiries Auwal Abdullahi therapistauwal@yahoo.com +2347035267375 Department of Physiotherapy, Bayero Unversity kano
City Postal code Country Position/Affiliation
Kano 700001 Nigeria Lecturer/ Bayero university kano
Role Name Email Phone Street address
Scientific Enquiries Auwal Abdullahi therapistauwal@yahoo.com +2347035267375 Department of Physiotherapy, Bayero University kano
City Postal code Country Position/Affiliation
Kano 700001 Nigeria Lecturer/ Bayero University kano
REPORTING
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Result URL Hyperlinks
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