To study the effect of developmental exercise therapy after removal of mCIMT on controlling upper limb spasticity in hemiplegic CP children.
Design
Randomized controlled trial
Settings and conduct
The motion analysis lab (Biomechanics Lab, College of Applied Medical Science, Prince Sattam bin Abdulaziz University).
Participants/Inclusion and exclusion criteria
Fifty-two hemiplegic children, ranging in age from four to six years (X`6.4±3.5 years) represented the sample of this study. They were selected from both sexes (26 females and 26 males) from the out-patient clinic of the Faculty of Physical Therapy, Cairo University, Egypt. The subjects enrolled in this study fulfilled the following criteria:
[1] The degree of spasticity ranged from 1+ to 2 grades according to the modified Ashowrth scale. (15)
[2] They were free from any associated disorders other than spasticity.
[3] The affected upper limb was free from any structural deformities; however, patients demonstrated variable degree of tightness.
[4] They had partial volitional control over the antispastic muscle groups.
[5] They had normal superficial skin sensation of the affected upper limb.
[6] All of them were within average IQ level.
Intervention groups
The children were divided randomly into two groups of equal number (I and II). Group I received developmental exercise therapy followed by a designed exercise program, while group II received mCIMT followed by the same exercise program given to group I.
Main outcome variables
Elbow extension and functional evaluation of reaching were measured before and after six months of the treatment program.
General information
Reason for update
Acronym
MCIT
IRCT registration information
IRCT registration number:IRCT20210909052421N1
Registration date:2022-05-07, 1401/02/17
Registration timing:retrospective
Last update:2022-05-07, 1401/02/17
Update count:0
Registration date
2022-05-07, 1401/02/17
Registrant information
Name
Nadia Radwan
Name of organization / entity
Prince Sattam Bin Abdulaziz University
Country
Saudi Arabia
Phone
+966 11 588 6500
Email address
n.radwan@psau.edu.sa
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2021-01-15, 1399/10/26
Actual recruitment start date
2020-02-16, 1398/11/27
Actual recruitment end date
2021-04-16, 1400/01/27
Trial completion date
2021-12-15, 1400/09/24
Scientific title
Modified Constraint Induced Therapy versus Developmental Exercises on Reaching Capacity in Hemiplegic Children
Public title
Effect of Modified Constraint Induced Therapy on reaching capacity in Hemiplegic Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hemiplegic children
Ranging in age from four to six years
The degree of spasticity ranged from 1+ to 2 grades according to the modified Ashowrth scale.
They were free from any associated disorders other than spasticity
The affected upper limb was free from any structural deformities; however, patients demonstrated variable degree of tightness
They had partial volitional control over the antispastic muscle groups.
All of them were within average IQ level.
Exclusion criteria:
The degree of spasticity ranged from 3to4 grades according to the modified Ashowrth scale.
Age
From 4 years old to 6 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
55
Actual sample size reached:
52
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization.
This technique maintains complete randomness of the assignment of a subject to a particular group. The method of simple randomization used is flipping a coin. For example, with two treatment groups (control versus treatment), the side of the coin (i.e., heads - control, tails - treatment) determines the assignment of each subject.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, care provider, and the data collectors are unaware of the treatment the participant receives.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Prince Sattam Bin Abulaziz university
Street address
ALmanifeia, Alraghi building
City
Alkharj
Postal code
00966
Approval date
2021-04-22, 1400/02/02
Ethics committee reference number
RHPT/021/010
Health conditions studied
1
Description of health condition studied
hemiplegic children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Elbow extension and upper limb kinematics ( movement time, peak velocity, time-to-peak velocity, percent of reach-to-peak velocity, number of movement units, percent of time of first movement unit) were the outcome variables
Timepoint
Elbow extension and functional evaluation of reaching were measured before and immediately after six months of the treatment program.
Method of measurement
Electro-Goniometer and 3-Dimensional motion analysis system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: who received modified constraint movement therapy
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
King Khalid Hospital
Full name of responsible person
Radwa S. Abdul-Rahman
Street address
ALmanifeia, Alraghi building
City
Alkharj
Postal code
00966
Phone
+966 11 588 6556
Email
n.radwan@psau.edu.sa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Prince Sattam Bin Abdulaziz University
Full name of responsible person
Nadia L. Radwan
Street address
ALmanifeia, Alraghi building
City
Alkharj
Postal code
00966
Phone
+966 11 588 6500
Email
s.alrawaili@psau.edu.sa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Prince Sattam Bin Abdulaziz University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Prince Sattam Bin Abdulaziz University
Full name of responsible person
Radwa Said
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
15- Nawal streeet
City
Madinat Naser
Province
Cairo
Postal code
002
Phone
+20 112 765 5396
Fax
Email
radwakku@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Cairo University
Full name of responsible person
Radwa Said
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
15 Nawal street
City
Madinat Naser
Province
Old Cairo
Postal code
002
Phone
+20 112 765 5396
Email
radwakku@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Cairo University
Full name of responsible person
Radwa Said
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Pediatrics
Street address
15 Nawal street
City
Madinat Naser
Province
Cairo
Postal code
002
Phone
+20 112 765 5396
Email
radwakku@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD