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.: PACTR202306821001093 Date of Approval: 29/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of hamstring stretching for spastic hemiplegic cerebral palsy children
Official scientific title Comparing the effect of two types of hamstring stretching on gait parameters in children with spastic hemiplegic cerebral palsy: A randomized clinical trial
Brief summary describing the background and objectives of the trial Children with hemiplegic CP show variable gait patterns. The abnormal gait pattern is a result for the primary brain injury, secondary deformities or compensatory mechanisms. Abnormal gait patterns depend on walking speed and the extent of affection . Pathologic hamstring tightness is the cause of reduced knee extension in the end of swing phase, leading to a shortened stride length in children with spastic cerebral palsy. Gait analysis is an important item of the global assessment of children with cerebral palsy. The kinematic changes of the hemiplegic limb are expected to affect the kinematics of the normal limb. This research will be conducted to cover a gap of knowledge about the effectiveness of reciprocal inhibition stretching technique, as there is a lack of literature and researches that show the efficacy of this type of stretching on increasing flexibility of the soft tissues. Also, there are no studies that measure the effectiveness of those types of stretching on functional activities of the lower limb such as gait in children with spastic cerebral palsy. Objectives of this study is directed to determine the effect of two stretching techniques for hamstring muscles in gait parameters and functions in spastic hemiplegic children with cerebral palsy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 02/02/2023
Actual trial start date 26/04/2023
Anticipated date of last follow up 18/07/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet 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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group stretching 8 weeks We will place each child in supine position with his paralytic limb’s hip and knee joints flexed at 90°, lumbar lordosis was maintained by a small lumbar roll, and the sound leg was supported in hip and knee extension by a belt, then we performed gradual extension of the knee to the point of mild resistance or just below the threshold of myoclonus 25 Active-Treatment of Control Group
Experimental Group Reciprocal inhibition technique 8 weeks The subject’s knee will be extended actively to the first appearance of resistance by hamstring then a moderate isometric contraction (approx. 75% of maximal) of the quadriceps muscle was then elicited by the therapist’s resistance just above the ankle joint for a period of five seconds, followed by passive stretching for the hamstring applied by the therapist by stabilizing the area above the knee joint by the proximal hand, while the distal hand cups the calcaneus to perform the passive stretch for 30 seconds. After a period of three seconds relaxation, the technique was repeated three times (for a total of four contractions). 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
confirmed diagnosis of spastic hemiplegic cerebral palsy aging between 6 and 10 years having flexible tightness of the hamstring level I on the gross motor function classification system–GMFCS hamstring spasticity grade of 1 or +1 according to Modified Ashworth scale BOTOX injection and/or lower limb surgery specially hamstring tenotomy within 6 months before joining the study using ambulatory aids and fixed contracture of hamstring. Child: 6 Year-12 Year 6 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 30/04/2023 Ethics committee of pharos University
Ethics Committee Address
Street address City Postal code Country
Pharos University, Canal El Mahmoudia Stree beside GfggD Pka, Afesandeieovernorate, Alexandria 21648 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome step length by the Vicon 612 Motion Analysis System using a Plug-in-Gait marker system, Markers reflecting infrared light were attached to known landmarks on the lower extremities (lateral malleolus, posterior calcaneus, second metatarsal head) pre and post treatment
Secondary Outcome walking speed measured by motion analysis system as the distance divided by time pre and post treatment
Secondary Outcome cadence measured by motion analysis system as number of steps per minute pre and post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy pharos university mahmoudeya street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Aliaa elabd mahmoudeya street alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Aliaa Elabd Mahmoudeya street Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aliaa Elabd aliaelabd88@gmail.com 00201069352446 Elmahmoudeya street
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Lecturer faculty of physical therapy Pharos University
Role Name Email Phone Street address
Public Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 Elmahmoudeya street
City Postal code Country Position/Affiliation
Alexandria 21523 Egypt Lecturer faculty of physical therapy pharos university
Role Name Email Phone Street address
Scientific Enquiries Aliaa Elabd aliaelabd88@gmail.com 00201069352446 Elmahmoudeya street
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer faculty of physical therapy pharos university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during this trial after deidentification Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol immediately after publication any one
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