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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03379038
Other study ID # IIRS-IUISB/PHD/007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 27, 2017
Est. completion date January 30, 2019

Study information

Verified date December 2017
Source Isra University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date January 30, 2019
Est. primary completion date January 20, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years to 11 Years
Eligibility 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 Design


Intervention

Other:
Progressive Physical Therapy
Stretching of the tight muscle, positioning, abdominal co activation; rolling etc to decrease muscle tone and functional independence.
Maintenance Physical Therapy
Same Physical therapy protocol but aim was to maintain current level of spasticity and functioning

Locations

Country Name City State
Pakistan Isra Institute or Rehabilitation Sciences, Isra University Islamabad Islamabad

Sponsors (1)

Lead Sponsor Collaborator
Isra University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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