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

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ClinicalTrials.gov Identifier: NCT03708757
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Imran Amjad, Riphah International University

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.

Condition or disease Intervention/treatment Phase
Spastic Cerebral Palsy Other: Post isometric relaxation - Group I Other: Eccentric Muscle contraction - Group II Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Experimental Study
Masking: Single (Participant)
Masking Description: This will be a single blinded study.Participants will be randomly allocated to PIRT Group (I) or EMET Group (II)
Primary Purpose: Treatment
Official Title: Comparison Of PIR Technique With Eccentric Isotonic Muscle Contraction on Hamstring Spasticity in CP Child
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Post isometric relaxation - Group I

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

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

Active Comparator: Eccentric Muscle contraction - Group II

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

Other: 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




Primary Outcome Measures :
  1. Goniometry [ Time Frame: 6th week ]
    change from baseline.This tool is used to measure range of motion of hip joint and knee joint


Secondary Outcome Measures :
  1. Gross motor Functional Scale [ Time Frame: 6th week ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708757


Contacts
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Contact: Imran Amjad, PHD* 03334503754 imran.amjad@riphah.edu.pk

Locations
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Pakistan
Imran Amjad Recruiting
Islamabad, Punjab, Pakistan, 46000
Contact: imran amjad, PHD*    03334503754    imran.amjad@riphah.edu.pk   
Riphah International University Recruiting
Islamabad, Pakistan, 44000
Contact: Imran Amjad, PHD*       imran.amjad@riphah.edu.pk   
Contact: Hania Farheen, MS       haniafarheen@hotmail.com   
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: imran Amjad Associate Professor

Publications:
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Responsible Party: Imran Amjad, Associate Professor, Riphah International University
ClinicalTrials.gov Identifier: NCT03708757     History of Changes
Other Study ID Numbers: RiphahIU Shafaq Bano
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imran Amjad, Riphah International University:
Cerebral palsy
Post Isometric Relaxation
Hamstring Spasticity

Additional relevant MeSH terms:
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Cerebral Palsy
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms