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.: PACTR202102862137038 Date of Approval: 17/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Motor Imagery Training on Gait and Balance in Children with Spastic Hemiplegia
Official scientific title Effect of Motor Imagery Training on Gait and Balance in Children with Spastic Hemiplegia
Brief summary describing the background and objectives of the trial Children with spastic hemiplegia may experience a variety of concomitant health conditions including, movement difficulty, postural and balance instability, muscle spasticity, difficulty with motor planning and control, and cognitive impairments (Hillary et al., 2016). Postural and balance disturbances occur due to the difficulty in maintaining the body segments aligned on a narrow base of support and there is a limitation in balance recovery in hemiplegic children contributing to delayed responses of ankle muscles, inappropriate sequencing, and increased coactivation of agonists/ antagonists muscles (Bigongiari et al., 2007). Rehabilitation techniques are predominantly focused on alleviating the compromised motor execution facet of action performance and have not specifically targeted the motor preparation or planning processes. Motor imagery is proposed to be a backdoor mechanism to access the motor system. It is a theoretically feasible method to activate the immature networks involved in motor control. Therefore, for individuals with motor planning problems this cognitive MI training may be useful to improve motor skills (Sharma et al., 2006). Although it has been shown to be beneficial in adult patients with stroke, and it still awaits empirical testing in young children with CP (Steenbergen et al., 2013). Despite the potential benefits of motor imagery training, the clinical use of motor imagery training for improving walking and balance abilities is not yet common compared with other conventional modalities in the rehabilitation of children with hemiplegia. Consequently, more research and further confirmation are needed regarding the impact of motor imagery training on the gait performance, balance and trunk endurance in children with hemiplegia. Therefore, the purpose of this study to investigate the effect of motor imagery training on balance and kinematic parameters of gait in children with hemiplegia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 09/01/2021
Actual trial start date 16/01/2021
Anticipated date of last follow up 15/05/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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 A selected physical therapy program 60 minutes, 3 times/week for 3 successive months including the following exercises -Facilitation of balance reactions from standing position including: Standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, standing on balance board and pushing the child in different directions. -Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands. - Strengthening exercises for weakened muscles in upper and lower limbs muscle. -Strengthening exercises for back and abdominal muscles. - Stretching exercises for tight muscles in upper and lower limbs. - Gait training activities for correction of gait pattern including: walking on balance beam, walking on balance board, walking on uneven surface, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs. - Jumping in place and jumping a board. 20 Active-Treatment of Control Group
Experimental Group Motor imagery training 60 minutes, 3 times/week for 3 successive months - As a preparation each child in the study group will be shown a video of 5 minutes of normal movements in a quiet room. - They will be positioned in a comfortable position (semi‑reclined sitting or high sitting with feet supported). - The screen is in the child’s visual field. - Children will be asked to close their eyes and imagine they will perform the physically practiced task for 10 minutes, similar to one shown in the video; subjects will be urged to imagine themselves from a first-person perspective, to feel their trunk, legs, hands and feet to concentrate on their movements. Sequence of the task will be verbally explained to the child for better recalling of sensations in muscles during the movements. During the entire exercise schedule child’s attention will be focused on the position, and movement of their body, on proprioceptive inputs coming from the leg muscles (quadriceps and adductors) and on the tactile sensations of foot floor contact. - Thereafter, the child will be asked to perform the sequence of tasks, rehearsed mentally for 20 minutes. - Repetition of the exercises will be based on their ability which could be a minimum of five repetitions per session to a maximum of ten repetitions per exercise session. - At the end children will be asked to relax. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Their chronological age will be ranged from 7-10 years. - Their motor function will be at level I according to according to Gross Motor Function Classification System GMFCS (Palisano et al., 2008). - The degree of spasticity for these children will ranged from grade 1 to 1+ according to Modified Ashworth Scale (Bohannon and Smith, 1987). - They will be able to follow instructions during evaluation and treatment. Children will be excluded from the study if they have: - Cardiovascular or respiratory disorders. - Botulinium muscular injection in the last 6 months - Surgical interference in lower limbs. - Musculoskeletal problems or fixed deformities in the spine and/or lower extremities. - Seizures. - Visual or hearing impairment. - Mentally retarded children Child: 6 Year-12 Year 7 Year(s) 10 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 05/12/2020 Research Ethics committee Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayyat Dokki Giza 12316 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Kinematic parameters of Gait by using Kinovea software in order to measure angular displacement of joints during some phases of gait cycle including ankle dorsiflexion angle in initial contact, knee extension angle in midstance, and hip flexion angle at the initial swing. Also, spatiotemporal parameters of gait will be measured including step length, stride length, walking speed and cadence. At baseline and after 3 months of intervention
Secondary Outcome Trunk muscle endurance In trunk endurance measurement, the examiner instructed the child to hold the test position as long as possible prior to all testing. Each position will be tested three times and the average time will be recorded. Endurance of the trunk muscles will be evaluated using three endurance tests designed to establish the isometric trunk muscles endurance including Trunk flexor endurance test, Trunk extensor endurance test and Lateral trunk endurance test. at baseline and after 3 months of intervention
Primary Outcome The balance will be measured using HUMAC balance system by using the following tests mCTSIB, Limits of stability, and weight shift tests. At baseline and after 3 months of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
outpatient clinic Faculty of Physical Therapy Cairo University 7 Ahmed El-Zayyat - Dokki - Giza Dokki 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eman Kamal Abdelmotaleb Mohamed 13 Alquds street Mubarak city Mansoura Dakahlya 35111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University Ahmed Elzayat Street Dokki 12613 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Faten Hassan Abdelaziem 7 Ahmed Elzayat Street Dokki Giza 12613 Egypt
Mohamed Ali ElShafey 7 Ahmed Elzayyat street Dokki Giza 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Kamal Abdelmoteleb Mohamed Abdelfatah eman_pediatrics2016@yahoo.com +201017173751 13 Alquds street Mubarak city
City Postal code Country Position/Affiliation
Mansoura Dakahlya 35111 Egypt Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Faten Hassan Abdelaziem faten.hassan@pt.cu.edu.eg +201008554818 Ahmed Elzayat Street
City Postal code Country Position/Affiliation
Dokki Giza 12613 Egypt Professor
Role Name Email Phone Street address
Scientific Enquiries Mohamed Ali Elshafey elrahmapt@gmail.com +201067179565 Ahmed Elzayat Street
City Postal code Country Position/Affiliation
Dokki Giza 12613 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after identification. Immediately following publication, No end date. Kinematic parameters of gait (step length, stride length, cadence, walking speed) Balance scores of mCTSIB, Limits of stability test, and Weight shift tests. Trunk muscle endurance tests' scores. Informed Consent Form,Statistical Analysis Plan,Study Protocol within 2 years of publication of the primary outcomes of the study. Using of controlled access approach with systems in place to review data access requests for the medical community. The study protocol, statistical analysis plan, consent form, result raw data will be available. Reviewers should be qualified in Physical therapy and rehabilitation.
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 - 10/02/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information