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

NCT ID: NCT03379038

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-27

Study Completion Date

2019-01-30

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy, Spastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Progressive Physical Therapy

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Maintenance Physical Therapy

Intervention Type OTHER

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

Interventions

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Progressive Physical Therapy

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

Intervention Type OTHER

Maintenance Physical Therapy

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

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

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

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isra University

OTHER

Sponsor Role lead

Responsible Party

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Waqar Ahmed Awan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Isra Institute or Rehabilitation Sciences, Isra University Islamabad

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IIRS-IUISB/PHD/007

Identifier Type: -

Identifier Source: org_study_id

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