NCT03708757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

October 9, 2018

Last Update Submit

August 7, 2019

Conditions

Keywords

Cerebral palsyPost Isometric RelaxationHamstring Spasticity

Outcome Measures

Primary Outcomes (1)

  • Goniometry

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

    6th week

Secondary Outcomes (1)

  • Gross motor Functional Scale

    6th week

Study Arms (2)

Post isometric relaxation - Group I

EXPERIMENTAL

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

Eccentric Muscle contraction - Group II

ACTIVE COMPARATOR

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

Interventions

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

Post isometric relaxation - Group I

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

Eccentric Muscle contraction - Group II

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with spastic cerebral palsy
  • Diplegic cerebral palsy
  • well oriented
  • Spastic hamstrings with Ashworth score +2 or +3

You may not qualify if:

  • Children with flaccid and mixed cerebral palsy
  • Quadriplegic and hemiplegic cerebral palsy
  • Mentally retarded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imran Amjad

Islamabad, Punjab Province, 46000, Pakistan

Location

Riphah International University

Islamabad, 44000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 23951281BACKGROUND
  • 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.

    PMID: 19083689BACKGROUND
  • 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.

    PMID: 18728130BACKGROUND
  • 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)

    BACKGROUND
  • 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.

    PMID: 19737297BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • imran Amjad

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This will be a single blinded study.Participants will be randomly allocated to PIRT Group (I) or EMET Group (II)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2018

First Posted

October 17, 2018

Study Start

November 15, 2018

Primary Completion

March 30, 2019

Study Completion

April 15, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Locations