Role Of Physical Therapy In Relieving Constipation In Children With Spastic Cerebral Palsy

February 16, 2019 updated by: Waqar Ahmed Awan, Isra University
This study was conducted to determine the effectiveness of Physical Therapy management in relieving constipation among Spastic Cerebral Palsy children. There were two groups, Group A received routine Physical Therapy and Group B received maintenance Physical Therapy (aim to maintain current level of spasticity, functionality to avoid deterioration of conadition as approved by ASRC)

Study Overview

Detailed Description

Physical therapy makes an integral part of the non-pharmacological, conservative management of cerebral palsy. Routine physical therapy aims to reduce spasticity, improve joint range of motion (ROM), and improve strength and mobility.

Passive ROM and stretching of lower limb and trunk increases parasympathetic activity and thus improves intestinal motility in prolonged bed ridden patients.Abdominal muscle training improves intestinal motility by two ways: mechanically by improving fecal propulsion towards rectum and neurologically by inducing parasympathetic activity to improve intestinal motility.20 Thermotherapy of back and abdomen in chronic constipation patient improves intestinal blood flow and parasympathetic activity.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Islamabad, Pakistan
        • Isra Institute or Rehabilitation Sciences, Isra University Islamabad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The inclusion criteria for the recruitment in the study were: spastic CP children on oral feeding with constipation between ages 2-12 years of both genders, spasticity above 1+ grade on modified Ashworth scale, functional activity level between 2-5 grades on gross motor functional classification scale (GMFCS).

Exclusion Criteria:

  • CP children with other systemic co-morbidities, physical deformity in GIT and intellectual disability were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progressive Physical Therapy (PPT)

Duration: Each child was given 40-minute session. Frequency: Two sets were performed, 5-10 active assisted sit-ups in each set at least once a day. Furthermore, the subjects were advised to use CP chair and standing frame/wall corner for sitting/standing position respectively for at least 15-30 minutes once a day. These exercises were followed by reflex inhibiting postures in sitting and lying positions.

Total 42 sessions were performed in 6 weeks (7 days/week). Intensity: The aim of the PPT was to improve the patient's level of spasticity, strength and activity level.

Stretching of the tight muscle, positioning, abdominal co activation; rolling etc to decrease muscle tone and functional independence.
Placebo Comparator: Maintenance Physical Therapy (MPT)

Duration: Each child was given 40-minute session. Frequency: Two sets were performed, 5-10 active assisted sit-ups in each set at least once a day. Furthermore, the subjects were advised to use CP chair and standing frame/wall corner for sitting/standing position respectively for at least 15-30 minutes once a day. These exercises were followed by reflex inhibiting postures in sitting and lying positions. Total 42 sessions were performed in 6 weeks (7 days/week).

Intensity:The aim of the MPT was to maintain the patient's current level of spasticity, strength and activity level.

Same Physical therapy protocol but aim was to maintain current level of spasticity and functioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spastcity Spasticity
Time Frame: 6 Weeks

Modified Ashworth scale (MAS)

  • 0 = No increase in muscle tone
  • 1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension
  • 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
  • 2 = More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
  • 3 = Considerable increase in muscle tone, passive movement difficult.
  • 4 = Affected part(s) rigid in flexion or extension
6 Weeks
Defecation Frequency (DF)
Time Frame: 6 weeks
Defecation frequency less than three times a week was considered constipation and measured by nominal scale 1= twice a month, 2= once a week, 3= twice a week and 4= daily
6 weeks
Constipation assessment scale (CAS)
Time Frame: 6 Weeks
used to determine the severity of constipation. The CAS consists of eight characteristics. Each of these characteristics is given a three point rating scale (0= no problem, 1= some problem, 2= severe problem). These scores are summed up to make a range from 0 for no constipation to 16 for the most severe constipation
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2017

Primary Completion (Actual)

January 20, 2019

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 20, 2017

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 16, 2019

Last Verified

December 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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