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

NCT03379038 | Completed DMC

• 1 other identifier: IIRS-IUISB/PHD/007
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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)

Conditions

Cerebral Palsy, Spastic

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Progressive Physical Therapy (PPT)

EXPERIMENTAL

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

Maintenance Physical Therapy (MPT)

PLACEBO COMPARATOR

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

Interventions

Progressive Physical Therapy OTHER

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

Progressive Physical Therapy (PPT)

Maintenance Physical Therapy OTHER

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

Maintenance Physical Therapy (MPT)

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

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

Sponsors & Collaborators

• Isra University: lead

Study Sites (1)

Isra Institute or Rehabilitation Sciences, Isra University Islamabad

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity; Constipation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: December 20, 2017
• Study Start: December 27, 2017
• Primary Completion: January 20, 2019
• Study Completion: January 30, 2019
• Last Updated: February 19, 2019

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

PA (1)