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.: PACTR201901582864286 Date of Approval: 02/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of locomotor training with a robotic-gait orthosis (lokomat) In Spasticity Modulation of Spastic Hemiplegic Children
Official scientific title Effect of locomotor training with a robotic-gait orthosis (lokomat) In Spasticity Modulation of Spastic Hemiplegic Children
Brief summary describing the background and objectives of the trial Studying of robotic-assisted locomotor training (lokomat) in spasticity modulation on cerebral palsied hemiplegic children is a strategy for determining its efficacy in reducing spasticity. Objective: To investigate the efficacy of robotic-assisted locomotor training (lokomat) in spasticity modulation.
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 Rehabilitation
Anticipated trial start date 15/05/2018
Actual trial start date 05/06/2018
Anticipated date of last follow up 27/11/2018
Actual Last follow-up date 28/12/2018
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
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 randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group traditional exercise program one hour.3 times per week 12 weeks (Stretching exercises, neurodevelopment technique (Bobath approach), strengthening exercises, balance and gait training exercises). This program was done in approximately 15 Active-Treatment of Control Group
Experimental Group lokomat gait training 1 hour 3 times per week 12 weeks lokomat gait training in addition to the traditional exercise program 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
grade 1 or 1+ according to modified Ashworth scale and grade II or III according to Manual Ability Classification Scale (MACS), they can understand and follow verbal commands and instructions included in the test, they had no sensory impairment or other neurological or psychological problems other than mild perceptual defects. any other neurological deficits such as convulsions, Involuntary movements or receiving muscle relaxants, children with impairment of sensation (superficial, deep and cortical). children with any other diseases such as cardiac disease and with severe mental retardation (IQ not less than 50). children with anatomical leg length discrepancy (lokomat limitation) exceeding 2 cm, fixed contracture, bone and joint deformities, bone articular instability (joint dislocation), inflammation of skin and open skin lesion around the trunk or limb. Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 7 Year(s) 14 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 02/12/2018 Faculty of physical therapy Cairo university
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat st. bein srayyat giza ,Egypt Giza 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluate gait parameters with 3D Motion analysis system for the ankle joint angle at initial contact, stride length, cadence and speed before and after intervention
Secondary Outcome Modified Ashworth scale: it used to spasticity assessment Before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
EDEN physical therapy center 6 October City Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funding 77 shalhoub st. ain shams Cairo , Egypt Cairo 11311 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Eden Healthcare 6 October city Giza 11411 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub street ahmed essmat ain shams
City Postal code Country Position/Affiliation
cairo 11311 Egypt Associate professor department of basic science faculty of physical therapy Cairo university
Role Name Email Phone Street address
Public Enquiries Wagdy Younan wagdywilliam28@yahoo.com 00201000527217 7Ahmed elzyat street bein srayat .Egypt
City Postal code Country Position/Affiliation
Giza 11511 Egypt lecturer of physiotherapy department of of growth and development in pediatric and it is Surgeries. Deraya university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mostafa drsergany_79@hotmail.com 00201140974442 77 shalhoub street ahmed essmat ain shams
City Postal code Country Position/Affiliation
Cairo 11311 Egypt Associate professor physiotherapist department of basic science faculty of physical therapy Cairo University.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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