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EFFECTS OF 8 WEEKS FUNCTIONAL TRAINING PROGRAM IN POSTURE CONTROL AND FUNCTIONAL MOBILITY IN SPASTIC HEMIPLEGIC CEREBERAL PALSY

Protocol summary

Study aim
To find out effects of functional training vs conventional training on posture control and functional mobility in spastic hemiplegic cerebral palsy
Design
Randomized clinical trial
Settings and conduct
Rehab cure Lahore
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Children diagnosed with cerebral palsy. Ages between 4 to 14 years. Children with gross motor functional classification system (GMFCS) level II or lll. Children with no mental retardation.The degree of spasticity according to Modified Ashworth Scale between grade 1 to 3 Exclusion Criteria: Children who had orthopedic surgery or used Botulinum toxin injection. Children with severe visual defect. Children having auditory problems. Children having vestibular issues. Children with severe understanding problems. Parents of children who didn't want to participate in study
Intervention groups
Subjects will receive 8 weeks treatment 3 times a week. session will be of 45 mints to 1 hour. Group A will receive conventional training program consist on TENS, hot pack, ROMs, stretching, bridging , balance training, supine to sit exercise, diagonal pattern ex with resistance, lateral walk, step ups, gait training, sit to stand, stair climbing, single leg standing, weight shift, cat position Group B will receive functional training program consist on Gym ball exercises, ex with resistance bands, unilateral pelvic bridging, Bosu ball ex , trampoline jumping, resistance kneeling, Treadmill walk, squats, cycling, cat walk, back walk, stepper ex, stair climbing
Main outcome variables
Pediatric Balance scale , Trunk control measurement scale, Five Times Sit to Stand Test, Timed Up and Go

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200909048676N1
Registration date: 2020-11-24, 1399/09/04
Registration timing: retrospective

Last update: 2020-11-24, 1399/09/04
Update count: 0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
Aeysha Gulzar
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
ash.gul2012@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-15, 1399/06/25
Expected recruitment end date
2020-11-15, 1399/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
EFFECTS OF 8 WEEKS FUNCTIONAL TRAINING PROGRAM IN POSTURE CONTROL AND FUNCTIONAL MOBILITY IN SPASTIC HEMIPLEGIC CEREBERAL PALSY
Public title
EFFECTS OF 8 WEEKS FUNCTIONAL TRAINING PROGRAM IN POSTURE CONTROL AND FUNCTIONAL MOBILITY IN SPASTIC HEMIPLEGIC CEREBERAL PALSY
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children diagnosed with cerebral palsy Ages between 4 to 14 years Children with gross motor functional classification system (GMFCS) level II or lll Children with no mental retardation The degree of spasticity according to Modified Ashworth Scale ranged between grade 1 to 3
Exclusion criteria:
Children who have had orthopedic surgery or Botulinum toxin injection Children with severe visual defect Children having auditory impairment Children having vestibular problem Children with severe perceptual deficit. Parents of children who don't want to participate in study
Age
From 4 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 14
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by lottery method. Allocation concealment through sealed envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Non probability convenient sampling will be used to recruit the individuals for the study. Randomization will be done by lottery method to divide the individuals to 2 treatment groups. sealed envelop will be used for allocation concealment.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Riphah College of Rehabilitation & Allied health Sciences
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate.
City
Lahore
Postal code
54770
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
RCRS-RE-MS-NMPT/FALL 19/026

Health conditions studied

1

Description of health condition studied
Spastic Hemiplegic Cerebral Palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy

Primary outcomes

1

Description
Postural control and functional mobility
Timepoint
Total 8 week program and no follow up. Primary outcome will be measured on 8th week
Method of measurement
Pediatric Balance scale, Trunk control measurement scale, Five Times Sit to Stand Test , Timed Up and Go

Secondary outcomes

empty

Intervention groups

1

Description
Subjects will receive 8 weeks treatment 3 times a week. session will be of 45 mints to 1 hour. Group A will receive conventional training program consist on TENS, hot pack, ROMs, stretching, bridging , balance training, supine to sit exercise, diagonal pattern ex with resistance, lateral walk, step ups, gait training, sit to stand, stair climbing, single leg standing, weight shift, cat position
Category
Treatment - Other

2

Description
Intervention group: Subjects will receive 8 weeks treatment 3 times a week. session will be of 45 mints to 1 hour. Group B will receive functional training program consist on Gym ball exercises, ex with resistance bands, unilateral pelvic bridging, Bosu ball ex , trampoline jumping, resistance kneeling, Treadmill walk, squats, cycling, cat walk, back walk, stepper ex, stair climbing
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehab cure Lahore
Full name of responsible person
Aeysha Gulzar
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate.
City
Lahore
Postal code
54770
Phone
+92 42 35126110
Email
ash.gul2012@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Prof. Dr. Anis Ahmad
Street address
Madar-e-Millat Road Quaid e Azam Industrial Estate
City
Lahore
Postal code
54770
Phone
+92 42 35126110
Email
ash.gul2012@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
100
Public or private sector
Private
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
Riphah International University
Full name of responsible person
Aeysha Gulzar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 35126110
Email
ash.gul2012@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Aeysha Gulzar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 35126110
Email
ash.gul2012@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Aeysha Gulzar
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madar-e-Millat Road, Quaid-e-Azam Industrial Estate
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 35126110
Email
ash.gul2012@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
there is no further decision and information decided yet
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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