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.: PACTR201703002073205 Date of Approval: 03/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Remodeling the Protocol of Lower Limb Constraint Induced Movement Therapy: A Pilot Randomized Controlled Trial
Official scientific title Remodeling the Protocol of Lower Limb Constraint Induced Movement Therapy: A Pilot Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Constraint induced movement therapy (CIMT) is used in the rehabilitation upper limb after stroke. However, there are very few studies on lower limb CIMT. Moreover, the tasks practiced during CIMT has been traditionally been measured using hours spent. In contrast, recent studies in upper limb CIMT have indicated that it is feasible, equally effective and more easier when task spent during CIMT are measured using number of repetition.The aim of this study is to compare the use of number of repetition (sCIMT) and duration in hours (tCIMT) of task practice as measures of dose during lower limb CIMT in patients with 6 months post-stroke.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 17/11/2014
Actual trial start date 17/11/2014
Anticipated date of last follow up 03/04/2015
Actual Last follow-up date 10/04/2015
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 18
Recruitment status Completed
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group sCIMT Each 40 times, 2 times a day, 5 times a week 4 weeks Sit to stand, forward and backward stepping, stair climbing and descending and side to side stepping each 5
Experimental Group tCIMT 2 hours of the same functional tasks in sCIMT per day , 5 times a week 4 weeks Sit to stand, forward and backward stepping, stair climbing and descending and side to side stepping 6
Control Group Control 2 hours of conventional therapy per day, 5 times a week 4 weeks Overground gait training and passive movement 7 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult stroke patients (¿ 18 years) who were ¿ 6 months post-stroke, had lower limb impairment and able to follow verbal and visual instructions,had no significant cognitive impairment (Minimental state examination score ¿17)and with low risk of fall (Tinetti gait and balance score ¿24). Patients with Lower Limb Deformity before stroke 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 11/11/2014 Research Ethics Committee of the Kano State Hospitals Management Board
Ethics Committee Address
Street address City Postal code Country
PMB 3540, Post Office road, Kano Kano 700001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lower Limb Fugl Meyer (Motor Function Subscale) Baseline 4 weeks post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Muhammad Abbdullahi Wase Specialists Hospital Nassarawa GRA, Kano Kano 700001 Nigeria
Murtala Muhammad Specialists Hospital, Kano Hospital Road, Kano Kano 700001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bayero University Kano PMB 3011, Gwarzo road 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
Auwal Abdullahi Department of Physiotherapy, Bayero University Kano Kano 700001 Nigeria
Khalid Aliyu Danlami Department of Physiotherapy, Murtala Muhammad Specialists Hospital, Kano 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
Role Name Email Phone Street address
Public Enquiries Auwal Abdullahi therapistauwal@yahoo.com +2347035267375 PMB 3011, Gwarzo Road
City Postal code Country Position/Affiliation
Kano 700001 Nigeria Department of Physiotherapy, Bayero University Kano
Role Name Email Phone Street address
Scientific Enquiries Auwal Abdullahi therapistauwal@yahoo.com +2347035267375 PMB 3011, Gwarzo Road
City Postal code Country Position/Affiliation
Kano Nigeria Department of Physiotherapy, Bayero University Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information