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.: PACTR202105527236004 Date of Registration: 21/05/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Mirror therapy feedback for selective motor control of the upper extremities in spastic hemiplegic cerebral palsy: A Randomized Controlled Trial
Official scientific title Mirror therapy feedback for selective motor control of the upper extremities in spastic hemiplegic cerebral palsy: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Cerebral palsy (CP) is the term for a range of non-progressive syndromes of posture and motor impairment that results from an insult to the developing central nervous system. Spasticity has been defined as a velocity-dependant increase in resistance to stretch. It is also commonly associated with hypertonicity, hyperreflexia, clonus and spread of contraction beyond the muscle stimulated. Spastic cerebral palsy is further subdivided into three types based on the affected muscles. Hemiplegia that involves the arm and leg on one side of the body but arm more affected than leg; diaplegia that involves four limbs but legs more than arms and quadriplegia that involves four limbs affected equally. Impaired elective motor control (SMC) is defined as ‘impaired ability to isolate the activation of muscles in a selected pattern in response to demands of a voluntary posture or movement’. A synergistic mass movement pattern is defined as a simultaneous, obligatory flexor or extensor pattern at two or more joints. These flexor or extensor synergies interfere with isolated joint movements resulting in obligatory muscle co-activation of flexor or extensor muscles during functional activities such as gait. This study aimed to investigate the effect of mirror therapy on selective motor control of the extremities in spastic hemiplegic cerebral palsy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/12/2018
Actual trial start date
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Neurodevelopmental technique with fine motor training for affected side total treatment time was 90 minutes., 3 sessions/ week six months Gross motor training based on neurodevelopment basis for 60 min and fine motor tasks for affected side for 30 min 15 Active-Treatment of Control Group
Experimental Group mirror therapy intervention total treatment time was 90 minutes., 3 sessions/ week. for six months the same guideline protocol which was given to the control group for 30 minutes in addition to fine motor tasks for affected upper limb for 30 minutes followed by 30 minutes of fine motor tasks for non-affected side while received mirror visual feedback from non-affected upper limb 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
children were diagnosed as having unilateral CP based on careful clinical assessment by a physiotherapist,they had mild to moderate spasticity according to the Modified Ashworth Scale, they were stable medically and psychologically, they were able to follow verbal commands or instructions. children who had any visual or auditory problems, children that had a history of epilepsy, children with fixed deformities in upper limb that interfere with fine motor functions, children with a history of any surgical interference in upper limbs for less than one year, Child: 6 Year-12 Year 6 Year(s) 9 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 07/02/2021 ethics committee FACULTY OF PHYSICAL THERAPY Cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Upper extremity by Selective control of upper extremity scale (SCUES): It was used to assess selective motor control for upper extremity All outcomes were measured at the baseline and the end of the interventions.
Secondary Outcome Upper extremity by Selective control of upper extremity scale (SCUES): It was used to assess selective motor control for upper extremity All outcomes were measured at the baseline and the end of the interventions.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Misr University for Science and Technology 6 october Giza 11568 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Amira Hussin Mohammed 69 Alkaser-Alani street Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Amira Hussin Mohammed Cairo Cairo 11562 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Amel Elsaid Abdelkariem October Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amira Mohammed amira_hussin77@yahoo.com +2001144495063 Cairo
City Postal code Country Position/Affiliation
Cairo 11562 Egypt Delta University for Science and Technology
Role Name Email Phone Street address
Public Enquiries Nader Elsayed ibrahimnader796@gmail.com 01128089233 6 October
City Postal code Country Position/Affiliation
Giza Egypt Beni Suef University
Role Name Email Phone Street address
Scientific Enquiries Amel Abdel Karim dramel64@hotmail.com +2001110061617 6 October
City Postal code Country Position/Affiliation
Giza Egypt Misr University for Science and Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes I will share IPD within 12 months of the study completion date, Clinical Study Report,Informed Consent Form,Statistical Analysis Plan August 2021 - controlled access . - access for tables,figures and appendixes. - Scientific enquirer responsible for decision and reviewing requests.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html Yes 10/01/2021 15/09/2021
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 10/01/2021
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information