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Completed

NCT Number: NCT03379038

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

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)

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Key information

Conditions

Cerebral Palsy, Spastic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Constipation Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Isra Institute or Rehabilitation Sciences, Isra University Islamabad

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive Physical Therapy

Other

Stretching of the tight muscle, positioning, abdominal co activation; rolling etc to decrease muscle tone and functional independence.

Maintenance Physical Therapy

Other

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Isra University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2017
Registry last updated
Feb 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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