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.: PACTR201611001646207 Date of Registration: 21/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Constraints induced movement therapy for lower limb
Official scientific title Effects of combined modified constraint-induced movement therapy upper and lower limb on physical functions and health-related quality of life of hemiparetic stroke survivors
Brief summary describing the background and objectives of the trial Stroke survivors with hemiparesis often exhibit impaired balance, ambulation dysfunction and asymmetrical weight distribution leading to physical dysfunction and decreased Health-Related Quality of Life (HRQoL). Constraint-Induced Movement Therapy (CIMT) is a known treatment approach in facilitating motor function after stroke. Modified CIMT for upper limb and lower limb when applied singly improve lower limb motor function, balance, gait and HRQoL of stroke survivors. However, effects of combined modified CIMT for upper and lower limbs (CoMCIMTULL) have not been investigated. Therefore, the effect of four-week CoMCIMTULL was compared with Modified CIMT Lower Limb (MCIMTLL) and Modified CIMT Upper Limb (MCIMTUL) among hemiparetic stroke survivors in this study. This single-blind randomized controlled trial involved random assignment of 56 consecutive stroke survivors to three groups: CoMCIMTULL (n=19), MCIMTLL (n=20), and MCIMTUL (n=17). The CoMCIMTULL group received both upper and lower limb CIMT for the reduced use of the upper limb and maladaptive use of the lower limb. The MCIMTLL group used the affected lower limb to lead weight bearing activities and exercises while the MCIMTUL group used the affected upper limbs for motor task practice. These treatments were administered in the clinic for two hours daily, five times per week for four consecutive weeks.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Stroke lower limb rehabilitation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/05/2014
Actual trial start date 21/08/2014
Anticipated date of last follow up 20/08/2015
Actual Last follow-up date 03/03/2015
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 56
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
UI/EC/14/101 Institute for advance medical research and training (IMRAT)College of medicine University of Ibadan
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 randomisation using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group 1- The modified Combined Constraint Induced Movement Therapy for upper and Lower Limbs Recieved both upper and lower limb treatment for 2 hours per day, 5 days a week . 4 weeks The intensive therapy for The upper limb focused on manipulating, grasping, picking, holding and moving objects from one spot to another using the affected limb. While for the lower limb intensive therapy focused on the use of the affected lower limb in strengthening exercise, balance training,functional training etc. 19 Dose Comparison
Experimental Group Group 2- The Modified Constraint Induced Movement Therapy for Lower Limb Recieved lower limb treatment for 2 hours per day, 5 days a week. 4 weeks The lower limb intensive therapy focused on the use of the affected lower limb in strengthening exercise, balance training,functional trainingetc. 20 Active-Treatment of Control Group
Control Group Group 3-The Modified Constraint Induced Movement Therapy for Upper Limb Recieved upper limb treatment for 2 hours per day, 5 days a week. 4 weeks The intensive therapy for The upper limb focused on manipulating, grasping, picking, holding and moving objects from one spot to another using the afected limb. 17
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Stroke survivors who volunteered to participate in every aspect of the study. (2) Stroke survivors who had first ever stroke for atleast 6 months prior to the study (3) Stroke survivors with minimal or no cognitive impairements based on ability to comprehend and execute 3-word commands. (4)Stroke survivors who had at least 90 degrees of passive range of motion of shoulder flexion and abduction, 45 degrees of shoulder external rotation, not less than 30 degrees of elbow extension, 45 degrees of forearm supination/pronation, no metacarpophalangeal joint should have greater than a 30 degree contracture. (5) Stroke survivors who had a minimum score of 2/3 on the Upright Motor Control Test (extension) which is a clinical indicator of ambulation potential post- stroke. (1) Stroke survivors whose blood pressure is not controlled (2) Stroke survivors with a score greater than 2 on Modified Ashworth scale (3) Stroke survivors participating in any experimental rehabilitation or drug studies (4) Stroke survivors with excessive pain in the affected upper or lower limb, as measured by a score of 6 or higher on a 10-point visual analog scale Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 05/05/2014 Kano state Hospital management board, ethics committee
Ethics Committee Address
Street address City Postal code Country
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 21/08/2014 Institute for advanced medical research and training , college of medicine university of ibadan, ibadan Nigeria
Ethics Committee Address
Street address City Postal code Country
College of medicine Ibadan, Nigeria Ibadan +235 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ¿ Height and body weight: This was measured using standardized procedures Week 0 baseline week 2 week4 post intervention
Primary Outcome Lower Limb Motor Function (LLMF) and balance were assessed using Fugyl Meyer Motor Assessement Scale, Lower Limb Use (LLU) with Lower Extremity Motor Activity Log, Weight Asymmetry Ratio (WAR) using two weighing scales, spatiotemporal gait parameters [gait speed (m/s) and stride length (m)] using foot print method The measurement were taken at baseline, 2nd week and 4th week time point of the study.
Secondary Outcome Health Related Quality of Live using the Stroke Impact Scale and balance confidence using Activities-specific Balance Confidence Scale, The measurement were taken at baseline (week 0), 2nd week and 4th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Murtala mohammed specialist hospital kano Emirs palace road, k/ mata, Kano Kano +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bank Loan First city monument bank, Azare, Branch Bauchi Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Self Sponsored Using Bank loan First City Monument Bank Jamera Road Azare +234 Nigeria Commercial Sector/Industry
Secondary Sponsor Federal Medical Centre Azare NO 54 Sulekatagum road Bauchi Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Prof BOA adegoke University of Ibadan Ibadan Nigeria
Head of Physiotherapu Department Murtala Mohammed Hospital Kofar Mata, Emirs Palace Road Kano +234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Lawan Umar lwnumar12@yahoo.com 08030949136 Ibadan
City Postal code Country Position/Affiliation
Nigeria Chief Physiotherapist/Phd student
Role Name Email Phone Street address
Public Enquiries T. K Hamzat talkzat@yahoo.com 07031096849 Physiotherapy Department, College of Medicine, University Of Ibadan
City Postal code Country Position/Affiliation
Ibadan +234 Nigeria Senior lecturer/professor of Physiotherapy
Role Name Email Phone Street address
Scientific Enquiries Prof BOA adegoke Babatunde babatundeadegoke@yahoo.com 08062280656 UI
City Postal code Country Position/Affiliation
Ibadan +234 Nigeria Senior Lecturer university of Ibadan
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks
Changes to trial information