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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03708757
Other study ID # RiphahIU Shafaq Bano
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2018
Est. completion date April 15, 2019

Study information

Verified date August 2019
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cerebral Palsy is a disorder of movement and posture due to deficit or lesion of immature brain. Out of all types of cerebral palsy 77.4% is spastic cerebral palsy. Spasticity is resistance to externally imposed movement increases with increasing speed of stretch and varies with the direction of joint movement. In this research the aim of our study is to measure the effects of post isometric relaxation and eccentric muscle energy technique of spasticity of hamstring muscle in cerebral palsy children in randomized controlled study. Study duration is of six months. Sampling will be lottery method. Inclusion criteria will include individuals having age between five to fifteen with diplegic cerebal palsy, well oriented and spastic hamstrings with Ashworth score +2 or +3.Exclusion criteria includes children with flaccid and mixed cerebral palsy, quadriplegic and hemiplegic cerebral palsy and mentally retarded. Data will be collected on structured questionnaire. those individuals who fulfill inclusion criteria will be divided into two groups .both groups will be treated with hot packs for ten minutes and static stretching. Group 1 will be given post isometric relaxation technique and group 2 will be given eccentric muscle energy technique. Post interventional analysis will be done at sixth week. Data will be analysed with SPSS 21.


Description:

The primary purpose of this study is to investigate effects of eccentric isotonic contraction on on hamstring flexibility of cerebral palsy children,and to investigate effects of post isometric relaxation on on hamstring flexibility of cerebral palsy children.It is a randomized control trial. this study will be conducted in PAF School for PSN Norkhan base Rawalpindi. Data collection time is from Oct 2018- March 2019. Sample size is 30 CP child,15 in each group calculated by Open Epi Tool.

Ap per Inclusion criteria only those participants will be included with age bracket 5-15 years,spastic diplegic , well oriented and on modified Ashworth scale their score is +2 or +3. Children with flaccid and mixed cerebral palsy,Quadriplegic and hemiplegic cerebral palsy or Mentally retarded will not be part of study. Those patients who fulfill inclusion criteria are divided in to two groups. Intervention will be provided and Assessments should be done on 1st on baseline and then after 6 weeks.Data Collection Tools will be Gross Motor Functional scale,Goniometry for measuring joint ranges and Motor Assessment Scale for measuring their functional status.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 15, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years to 15 Years
Eligibility Inclusion Criteria:

- Children with spastic cerebral palsy

- Diplegic cerebral palsy

- well oriented

- Spastic hamstrings with Ashworth score +2 or +3

Exclusion Criteria:

- Children with flaccid and mixed cerebral palsy

- Quadriplegic and hemiplegic cerebral palsy

- Mentally retarded

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Post isometric relaxation - Group I
Post isometric relaxation (PIR) techniques are used by orthopedic manual physical therapists to enhance the flexibility of muscles and to increase the joint range of motion
Eccentric Muscle contraction - Group II
and Eccentric muscle energy techniques(EME) techniques are used by orthopedic manual physical therapists to enhance the flexibility of muscles and to increase the joint range of motion

Locations

Country Name City State
Pakistan Imran Amjad Islamabad Punjab
Pakistan Riphah International University Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

Adel Rashad ahmed , A comparative study of muscle energy technique and dynamic stretching on hamstring flexibility. Bulletin of faculty of physical therapy.2011;16(1)

Czaprowski D, Leszczewska J, Kolwicz A, Pawlowska P, Kedra A, Janusz P, Kotwicki T. The comparison of the effects of three physiotherapy techniques on hamstring flexibility in children: a prospective, randomized, single-blind study. PLoS One. 2013 Aug 12;8(8):e72026. doi: 10.1371/journal.pone.0072026. eCollection 2013. — View Citation

Lee GP, Ng GY. Effects of stretching and heat treatment on hamstring extensibility in children with severe mental retardation and hypertonia. Clin Rehabil. 2008 Sep;22(9):771-9. doi: 10.1177/0269215508090067. — View Citation

Reid S, Hamer P, Alderson J, Lloyd D. Neuromuscular adaptations to eccentric strength training in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2010 Apr;52(4):358-63. doi: 10.1111/j.1469-8749.2009.03409.x. Epub 2009 Sep 8. — View Citation

Smith M, Fryer G. A comparison of two muscle energy techniques for increasing flexibility of the hamstring muscle group. J Bodyw Mov Ther. 2008 Oct;12(4):312-7. doi: 10.1016/j.jbmt.2008.06.011. Epub 2008 Aug 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Goniometry change from baseline.This tool is used to measure range of motion of hip joint and knee joint 6th week
Secondary Gross motor Functional Scale Change from baseline.Tool is used to measure the functional status of patients. The Gross Motor Function Classification System (GMFCS) for cerebral palsy is based on self-initiated movement, with emphasis on sitting, transfers, and mobility. It gives information about levels of limitations.
LEVEL I - Walks without Limitations LEVEL II - Walks with Limitations LEVEL III - Walks Using a Hand-Held Mobility Device LEVEL IV - Self-Mobility with Limitations; May Use Powered Mobility LEVEL V - Transported in a Manual Wheelchair
6th week
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