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

• ClinicalTrials.gov Identifier: NCT03379038
• Recruitment Status: Completed
• First Posted: December 20, 2017
• Last Update Posted: February 19, 2019
• Sponsor: Isra University
• Information provided by (Responsible Party): Waqar Ahmed Awan, Isra University

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)

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy, Spastic	Other: Progressive Physical Therapy; Other: Maintenance Physical Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention 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)
• Primary Purpose: Prevention
• Official Title: Role Of Physical Therapy In Relieving Constipation In Children With Spastic Cerebral Palsy
• Actual Study Start Date: December 27, 2017
• Actual Primary Completion Date: January 20, 2019
• Actual Study Completion Date: January 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Pakistan

Isra Institute or Rehabilitation Sciences, Isra University Islamabad

Islamabad, Pakistan

Sponsors and Collaborators

Isra University

More Information

• Responsible Party: Waqar Ahmed Awan, Assistant Professor, Isra University
• ClinicalTrials.gov Identifier: NCT03379038
• Other Study ID Numbers: IIRS-IUISB/PHD/007
• First Posted: December 20, 2017
• Last Update Posted: February 19, 2019
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Waqar Ahmed Awan, Isra University:

Cerebral Palsy; Spasticity; Constipation; Gross Motor Functional Classification Scale; Defecation Frequency; Constipation Severity

Additional relevant MeSH terms:

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