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Spastic Cerebral PalsyNCT03708757

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

A study testing Post isometric relaxation - Group I and Eccentric Muscle contraction - Group II in people with Spastic Cerebral Palsy, run by Riphah International University at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 5 to 15 years
Conditions the study is for
Spastic Cerebral Palsy
What is being tested?
Post isometric relaxation - Group I and Eccentric Muscle contraction - Group II
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesPakistan
Study dates
15 Nov 2018to 15 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

  • Imran Amjad

    Islamabad, Punjab Province, 46000

  • Riphah International University

    Islamabad, 44000

Other trials in Pakistan

About this study

Official title: Comparison Of PIR Technique With Eccentric Isotonic Muscle Contraction on Hamstring Spasticity in CP Child

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.

Read the 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.

Being tested
Post isometric relaxation - Group I, Eccentric Muscle contraction - Group II
Keywords
Cerebral palsy, Post Isometric Relaxation, Hamstring Spasticity
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Post isometric relaxation - Group IOther

    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 IIOther

    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

Study groups in NCT03708757
Study groupRoleWhat they receive
Post isometric relaxation - Group IExperimentalGroup 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
Receives: Other: Post isometric relaxation - Group I
Eccentric Muscle contraction - Group IIActive comparatorEccentric 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
Receives: Other: Eccentric Muscle contraction - Group II

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Goniometry

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

    Measured: 6th week

Secondary outcomes (1)

  1. 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

    Measured: 6th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2018
  2. Study start15 Nov 2018
  3. Primary completion30 Mar 2019
  4. Study completion15 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Experimental Study
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03708757
Sponsor's protocol ID
RiphahIU Shafaq Bano
Status last verified
Aug 2019
First submitted
9 Oct 2018
Last updated
8 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23951281

  • 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.

    PubMed 19083689

  • 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.

    PubMed 18728130

  • 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)

  • 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.

    PubMed 19737297

Questions about this trial

What is this clinical trial studying?

A study testing Post isometric relaxation - Group I and Eccentric Muscle contraction - Group II in people with Spastic Cerebral Palsy, run by Riphah International University at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Goniometry (time frame: 6th week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03708757, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.

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