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.: PACTR202202830392683 Date of Approval: 15/02/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Robotic gait orthosis on kinematic gait parameters in spastic hemiplegic children
Official scientific title Effect of Robotic gait orthosis on kinematic gait parameters in spastic hemiplegic children
Brief summary describing the background and objectives of the trial Background. Studying 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 gait orthosis on kinematic gait parameters in spastic hemiplegic children
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 28/02/2022
Actual trial start date
Anticipated date of last follow up 01/09/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group selected exercise program three times a week for 12 successive weeks selected exercise program: 1. Stretching exercises, 2. Neurodevelopmental technique i.e., Bobath approach. 3. Strengthening exercises. 4. Balance and gait training. 20 Active-Treatment of Control Group
Experimental Group Lokomat gait training 3 days/week for 12 successive weeks same exercise program as the control group in addition to Lokomat gait training 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The children were selected according to the following criteria: 1. Age range between 7 to 12 years. 2. Grade 1 or 1+spasticity according to modified Ashworth scale. 3. Can understand and follow verbal commands and instructions included. 4. grade I or II according to gross motor function classification system (GMFCS). 5. No sensory impairment or any other neurological or psychological impairment. Children were excluded from the study if they have: 1. Uncooperative or self-aggressive behavior. 2. Severe cognitive deficits. 3. Mechanical ventilation. 4. Hip, knee, and ankle arthrodesis. 5. Severely fixed contractures. 6. Severe osteoporosis. 7. Open skin lesions in the lower limbs. 8. Circulatory problems. Child: 6 Year-12 Year 7 Year(s) 12 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 12/09/2021 Faculty of physical therapy
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat street Giza 11511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome kinematic gait parameters pre and post intervention
Secondary Outcome muscle power and muscle strength pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Haven physical therapy center 6th October Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Soad Mohammed Ibrahim 28 naser city Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Haven physical therapy center 6th October Giza Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Soad Ibrahim soaad.elomda@gmail.com 01221525786 28 naser city
City Postal code Country Position/Affiliation
Cairo Egypt senior physical therapy specialist at police authority hospitals
Role Name Email Phone Street address
Public Enquiries Mohamed Elshafey elrahmapt@gmail.com 01067179565 15 bein srayat street
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor Department of Physical Therapy for Pediatrics Faculty of Physical Therapy Cairo University Egypt
Role Name Email Phone Street address
Scientific Enquiries Wagdy Amin wagdywilliam28@yahoo.com 01098382935 70 Feisal street
City Postal code Country Position/Affiliation
Giza Egypt Lecturer Department of Physical Therapy for Disturbance of Growth and Development in Pediatric and it is Surgeries Faculty of Physical Therapy Deraya University Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Statistical Analysis Plan,Study Protocol 12 months period time after publication Controlling access to data
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