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

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Progressive Physical Therapy
Maintenance Physical Therapy
Sponsored by
Isra University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Palsy, Spastic focused on measuring Cerebral Palsy, Spasticity, Constipation, Gross Motor Functional Classification Scale, Defecation Frequency, Constipation Severity

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Isra Institute or Rehabilitation Sciences, Isra University Islamabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Progressive Physical Therapy (PPT)

Maintenance Physical Therapy (MPT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
December 15, 2017
Last Updated
February 16, 2019
Sponsor
Isra University
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1. Study Identification

Unique Protocol Identification Number
NCT03379038
Brief Title
Role Of Physical Therapy In Relieving Constipation In Children With Spastic Cerebral Palsy
Official Title
Role Of Physical Therapy In Relieving Constipation In Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 27, 2017 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isra University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Cerebral Palsy, Spasticity, Constipation, Gross Motor Functional Classification Scale, Defecation Frequency, Constipation Severity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The two groups were progressive physical therapy group and maintenance physical therapy group. For any given subject, spasticity, defecation frequency and constipation severity evaluations were completed on the same day. Each subject in PPT group completed 6 weeks of physical therapy sessions which were aimed to decrease spasticity, increase ROM, and improve strength and functional activity level. Each subject was evaluated for changes in symptoms on, 2nd week, 4th week and 6th week. In MPT group same protocol was used but the aim was to maintain current status of level of spasticity, ROM, strength and functional activity. After 6 weeks of physical therapy sessions were completed both groups underwent a 2-week washout period to eliminate the effects of 6-week physical therapy. After the washout period subjects were crossed over from PPT group to MPT group and vice versa.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Physical Therapy (PPT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Maintenance Physical Therapy (MPT)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Progressive Physical Therapy
Intervention Description
Stretching of the tight muscle, positioning, abdominal co activation; rolling etc to decrease muscle tone and functional independence.
Intervention Type
Other
Intervention Name(s)
Maintenance Physical Therapy
Intervention Description
Same Physical therapy protocol but aim was to maintain current level of spasticity and functioning
Primary Outcome Measure Information:
Title
Spastcity Spasticity
Description
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
Time Frame
6 Weeks
Title
Defecation Frequency (DF)
Description
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
Time Frame
6 weeks
Title
Constipation assessment scale (CAS)
Description
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
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Isra Institute or Rehabilitation Sciences, Isra University Islamabad
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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