Comparison of the mean score of Dexterity,supination and wrist extention and grasp of the affected limb before and after the intervention in two groups of control and intervention in children and adolescents of spastic hemiplegia aged 9 to 14 years
Design
The subjects of the study group were selected in a sample size of 30 people and randomly selected (draw) in the control and intervention groups. This study is based on a single blind clinical evaluation.
Settings and conduct
The study site is a rehabilitation center. For both individuals, the routine occupational therapy program is performed. the subjects in the intervention group are treated with a mirror for 5-6 weeks and one day (three days a week) and each session for 30 minutes by the researcher. The initial and final evaluation is done by another therapist who is not aware of the division of the groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of spastic hemiplegic cerebral palsy by a pediatric neurologist
Children and adolescents aged 14 to 9 years.
No Botox injection in the upper 6 months
Exclusion criteria: If the child or his family are reluctant to continue treatment at each stage of the treatment
If he or she participates in another program at the same time
Intervention groups
People are divided into two groups: intervention and control. Individuals of both groups are under the routine rehabilitation program. In addition to the current program, the intervention group undergoes mirror therapy for 6 weeks and 3 days a week
Main outcome variables
In this study, variables such as Dexterity, forearm Supination and Wrist extention, and Grasp are examined
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180627040262N1
Registration date:2018-07-11, 1397/04/20
Registration timing:registered_while_recruiting
Last update:2018-07-11, 1397/04/20
Update count:0
Registration date
2018-07-11, 1397/04/20
Registrant information
Name
Akbar Narimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3288 0817
Email address
minookalantari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-08-11, 1397/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the effect of mirror therapy on upper limb function in the children with hemiplegic cerebral palsy aged 9_14 years old
Public title
Effect of mirror therapy in cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of spastic hemiplegic cerebral palsy by pediatric neurologist
Children aged 9 to 14 years old
Lack of cognitive impairment and half-body forgetfulness and lack of orthopedic defects based on expert examination and diagnosis
Non-verbal and visual impairment based on a doctor's examination
no surgical procedures including tendon transfer
Having attention and concentration to the mirror and the ability to perform the relevant exercises within a specified time (at least 10 minutes) based on the interventionist view
Acquire level1 - 3 of the Manual Ability classification System (MACS)
Tone of the affected upper limb less than or equal to 2, was corrected based on the modified Ashworth scale.
Not having Botox injections over the last 6 months
Exclusion criteria:
Patients who for any reason have more than four alternate sessions or two consecutive sessions unable to participate in the program are excluded
If the child or his family are reluctant to continue treatment at each stage of the treatment
If the child fails to focus on the duration of the treatment
If he or she participates in another program at the same time
Age
From 9 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this clinical trial study, a list of spastic hemiplegia children and adolescents in public, private and extraordinary schools in Tabriz, which were in the age range of 14 to 9 years old, were selected and entered randomly. (Lottery) were divided into two groups of control and intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
The initial evaluation and final evaluation will be done by another therapist who is not aware of the grouping of the groups. . Individuals' referrals for implementing the therapeutic interventions of the two control and intervention groups are adjusted so that the two groups do not have contact during the study.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Measurement of dexterity before intervention and after intervention
Method of measurement
Dexterity is measured using box and block.
2
Description
Active ROM of wrist extention and Supination
Timepoint
Measurement of ROM before intervention and after intervention
Method of measurement
ROM is measured using Guniameter
3
Description
Grasp
Timepoint
Measurement of Grasp before intervention and after intervention
Method of measurement
Grasp is measured using Dynamometer
4
Description
Upper limb function
Timepoint
Measurement of Upper limb function before intervention and after intervention
Method of measurement
Upper limb function is measured using Fugle meyer test
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: In addition to the routine rehabilitation program, the subjects in the intervention group receive mirror therapy for 6 weeks ( three days a week) and each session for 30 minutes. In the routine rehabilitation program, Bobath exercises, such as RIP, active and passive exercises( flexion, and extension of the shoulder, elbow, and wrists) are used. In addition to these exercises, several functional exercises, such as bring a cup up into the mouth, drawing a circle and, squeeze a towel will done.
Category
Rehabilitation
2
Description
Control group:subjects in this group receive a routine rehabilitation for six weeks. In the routine rehabilitation program, Bobath exercises, such as RIP, active and passive exercises( flexion, and extension of the shoulder, elbow, and wrists) are used. In addition to these exercises, several functional exercises, such as bring a cup up into the mouth, drawing a circle and, squeeze a towel will done.program
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ofogh
Full name of responsible person
Akbar Narimani
Street address
2nd Floor, Atteba building, Next to Nikookari Hospital, Abbasi Street