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)

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy, Spastic
• Intervention / Treatment: Other: Progressive Physical Therapy; Other: Maintenance Physical Therapy

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	Other: Progressive Physical Therapy; 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.	Other: Maintenance Physical Therapy; 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	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)	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)	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

• Sponsor: Isra University

Study record dates

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

• Keywords: Cerebral Palsy; Constipation; Spasticity; Gross Motor Functional Classification Scale; Defecation Frequency; Constipation Severity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Signs and Symptoms, Digestive; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Constipation; Paralysis; Muscle Spasticity
• Other Study ID Numbers: IIRS-IUISB/PHD/007

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