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Effect of Post Isometric Relaxation Technique & Eccentric Muscle Contraction on Hamstring Spasticity in CP

Primary Purpose

Spastic Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Post isometric relaxation - Group I
Eccentric Muscle contraction - Group II
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Cerebral palsy, Post Isometric Relaxation, Hamstring Spasticity

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imran Amjad
  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Post isometric relaxation - Group I

Eccentric Muscle contraction - Group II

Arm Description

Group I will receive post isometric relaxation techniques in order to reduce hamstring spasticity. This technique induces relaxation and decreases spasticity in muscles Post isometric relaxation (3 sets of 10 repetitions ,1 session in a day, 30 minutes, 4 days a week for 6 weeks.) Stretching Exercises (10 reps 3sets) hold for 2 sec

Eccentric Muscle contraction lengthens the spastic muscles and enhance joint flexibility. Hot Pack for (10 MINTS) Eccentric stretching (3 sets of 10 repetitions ,1 session in a day, 30 minutes, 4 days a week for 6 weeks.) Stretching Exercise(10 reps 3sets) hold for 2 sec In both experimental groups PIR and Eccentric stretching is applied on hamstring to

Outcomes

Primary Outcome Measures

Goniometry
change from baseline.This tool is used to measure range of motion of hip joint and knee joint

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2018
Last Updated
August 7, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT03708757
Brief Title
Effect of Post Isometric Relaxation Technique & Eccentric Muscle Contraction on Hamstring Spasticity in CP
Official Title
Comparison Of PIR Technique With Eccentric Isotonic Muscle Contraction on Hamstring Spasticity in CP Child
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
Cerebral palsy, Post Isometric Relaxation, Hamstring Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental Study
Masking
Participant
Masking Description
This will be a single blinded study.Participants will be randomly allocated to PIRT Group (I) or EMET Group (II)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Post isometric relaxation - Group I
Arm Type
Experimental
Arm Description
Group I will receive post isometric relaxation techniques in order to reduce hamstring spasticity. This technique induces relaxation and decreases spasticity in muscles Post isometric relaxation (3 sets of 10 repetitions ,1 session in a day, 30 minutes, 4 days a week for 6 weeks.) Stretching Exercises (10 reps 3sets) hold for 2 sec
Arm Title
Eccentric Muscle contraction - Group II
Arm Type
Active Comparator
Arm Description
Eccentric Muscle contraction lengthens the spastic muscles and enhance joint flexibility. Hot Pack for (10 MINTS) Eccentric stretching (3 sets of 10 repetitions ,1 session in a day, 30 minutes, 4 days a week for 6 weeks.) Stretching Exercise(10 reps 3sets) hold for 2 sec In both experimental groups PIR and Eccentric stretching is applied on hamstring to
Intervention Type
Other
Intervention Name(s)
Post isometric relaxation - Group I
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Eccentric Muscle contraction - Group II
Intervention Description
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
Primary Outcome Measure Information:
Title
Goniometry
Description
change from baseline.This tool is used to measure range of motion of hip joint and knee joint
Time Frame
6th week
Secondary Outcome Measure Information:
Title
Gross motor Functional Scale
Description
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
Time Frame
6th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
imran Amjad
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imran Amjad
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
23951281
Citation
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.
Results Reference
background
PubMed Identifier
19083689
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.
Results Reference
background
PubMed Identifier
18728130
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.
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
19737297
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.
Results Reference
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Effect of Post Isometric Relaxation Technique & Eccentric Muscle Contraction on Hamstring Spasticity in CP

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