Protocol summary

Summary
Objectives: In children with spastic hemiplegia, sensorimotor disorder cause inability to do many manual skills, followed by the restriction on doing daily activities and assignments. Because of the important role of manual skills in children’s adaptation to the environment and independence in daily life activities, development of these skills is of great importance. The present research aimed to study the effect of sensorimotor training on improving hand function in children with spastic hemiplegia. Experimental design: The present research is a single-blind experimental study. Participants: 40 children with cerebral palsy (spastic hemiplegia) aged 4-12. In the control group, 20 children spastic hemiplegia will receive conventional training on hand function including stretching, strengthening muscles, and fine movements of hands 3 sessions a week for 4 weeks. In the intervention group, 20 other children with spastic hemiplegia, in addition to conventional training on hand function, will perform sensorimotor exercises 3 sessions a week for 4 weeks (each session will last 1 hour). Treatment will be based on the principles of sensory retraining and further use hands. However, unlike the traditional retraining methods in which hands are mainly passive during the intervention, this training requires active and exploratory movements of hands. It should be noted that the sense of sight will be eliminated in order to further stimulate the sensory function of hands. These exercises include detection of objects and their weight, texture, and temperature, manipulation, and subtle movements. Participants of both groups will be evaluated before and after the intervention and a follow-up measurement will be performed in the intervention group one month after the intervention. primary and secondary assessment is Stereognosis, Proprioceptive, Purdue pegboard, MAS, Nine Hole Peg Test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030626926N1
Registration date: 2016-12-09, 1395/09/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-09, 1395/09/19
Registrant information
Name
Karim Ayoubi Avaz
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3334 0867
Email address
ayoubikarim@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neuromuscular rehabilitation research center
Expected recruitment start date
2016-06-11, 1395/03/22
Expected recruitment end date
2017-02-10, 1395/11/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Sensorimotor Training on hand function of children with spastic hemiplegia 4-12 years
Public title
study of hand function in cerebral palsy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Medical diagnosis of children with spastic hemiplegia; being aged 4-12; the ability to communicate in order to perform tests; mild to moderate spasticity based on the Modified Ashworth Scale, and having a sense of protection in the palm of the hand (the minimum monofilament No. 6.65 and 33 grams). Exclusion criteria: Lack of cooperation during the intervention or parent’s request for stopping the intervention; orthopedic problems such as fixed deformity in hand; impairment of attention and concentration; and significant hearing and vision problems.
Age
From 4 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Semnan University of Medical Sciences Ethics Committee
Street address
No.47,Semnan university of medical sciences, Basij Blvd, Semnan, Iran
City
Semnan
Postal code
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
Ir.semums.rec.1395.22

Health conditions studied

1

Description of health condition studied
Spastic hemiplegic cerebral palsy
ICD-10 code
G80.2, G81
ICD-10 code description
G80.2 Spastic hemiplegic cerebral palsy G81.1 Spastic hemiplegia

Primary outcomes

1

Description
hand fine movement
Timepoint
Before intervention, The end of each 4 treatment sessions, end of intervention and 1 month after the end of intervention
Method of measurement
purdopegboard, Nine Hole Peg Test

Secondary outcomes

1

Description
sensory of hand function
Timepoint
Before intervention,The end of each 4 treatment sessions, end of intervention and 1 month after the end of intervention
Method of measurement
sterognosis and Proprioceptive

Intervention groups

1

Description
Intervention group:In the intervention group, in addition to conventional occupational therapy training on hand function, will perform sensorimotor exercises 3 sessions a week for 4 weeks (each session will last 1 hour).
Category
Rehabilitation

2

Description
control group:In the control group, patients will receive conventional occupational therapy training on hand function including stretching, strengthening muscles, and fine movements of hands 3 sessions a week for 4 weeks (each session will last 1 hour).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neruromuscular rehabilitation research center
Full name of responsible person
Karim Ayoubi Avaz
Street address
No.24, Neuromuscular Rehabilitation Research Center, Ghods Blvd, Mashahir square, Semnan, Iran
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidipour
Street address
No.47,Semnan university of medical sciences, Basij Blvd, Semnan, Iran
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Karim Ayoubi Avaz
Position
Master of siences / Faculty member
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Rehabiliation depatement, Km 5 Semnan to Damghan road, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ayoubikarim1@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Karim Ayoubi Avaz
Position
Master of siences / Faculty member
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Rehabiliation depatement, Km 5 Semnan to Damghan road, Semnan, Iran
City
semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ayoubikarim1@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Karm Ayoubi Avaz
Position
Master of siences / Faculty member
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Rehabiliation depatement, Km 5 Semnan to Damghan road, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
ayoubikarim1@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...