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Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy, Respiration; Decreased

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Threshold (IMT)
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cerebral Palsy focused on measuring cerebral palsy, inspiratory muscle training

Eligibility Criteria

7 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 7-14 years
  • Diagnosed to spastic cerebral palsy
  • Gross Motor Function Classification System levels I or II.
  • Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments
  • Child are able to demonstrate sufficient co-operation and cognitive understanding participating

Exclusion Criteria:

  • Active medical condition impairment (pneumonia etc.)
  • Do not accommodate the study
  • Do not want to attempt the study

Sites / Locations

  • Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treatment Group

Control Group

Arm Description

The treatment group received Inspiratory muscle training (IMT) at 40% of maximal mouth pressure (PImax) by using Threshold IMT and training loads were adjusted to maintain 40% of the PImax weekly. The PImax was measured at supervised sessions each week, and 40% of the measured value was determined as the new training work load.

The control group received sham Inspiratory muscle training (IMT) at a fixed work load, 5% of PImax by using Threshold IMT.

Outcomes

Primary Outcome Measures

Timed Up and Go Test
this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the child is expected to wear their regular footwear and use any mobility aids that they would normally require.

Secondary Outcome Measures

Activities of daily living using with Pediatric Evaluation of Disability Inventory
PEDI scale
Pulmonary Function Test
spirometry
Respiratory muscle strength
Mouth pressure device
Functional exercise capacity
six minute walk test
Change in trunk control over time assessed with Trunk Control Measurement Scale
Assessing change in trunk control

Full Information

First Posted
December 10, 2016
Last Updated
September 27, 2018
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT02998281
Brief Title
Effects of Inspiratory Muscle Training in Children With Cerebral Palsy
Official Title
Effects of Inspiratory Muscle Training on Respiratory Functions, Trunk Control, Activities of Daily Living, Functional Exercise Capacity and Quality of Life in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Even if cerebral palsy not directly effect respiratory system, impairment of nervous and muscle systems, because of the brain damage, may cause respiratory functions impairment. In literature, it has been showed that children with cerebral palsy have decreased respiratory muscle strength and associated with trunk control, quality of life and respiratory functions. But, there is no study in literature that aims to increase respiratory muscle strength in these children. Hence, the aim of this study is to investigate effects of inspiratory muscle training on respiratory functions, trunk control, activities of daily living, functional exercise capacity and quality of life in children with cerebral palsy.
Detailed Description
A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth pressure, the control group will receive sham inspiratory muscle training at a fixed work load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7 days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function test will be evaluated with using spirometry, respiratory muscle strength using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI), functional exercise capacity usin with six minute walk test (6MWT) and quality of life using with Cerebral Palsy Quality of Life Questionnaire (CPQOL).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Respiration; Decreased
Keywords
cerebral palsy, inspiratory muscle training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
The treatment group received Inspiratory muscle training (IMT) at 40% of maximal mouth pressure (PImax) by using Threshold IMT and training loads were adjusted to maintain 40% of the PImax weekly. The PImax was measured at supervised sessions each week, and 40% of the measured value was determined as the new training work load.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
The control group received sham Inspiratory muscle training (IMT) at a fixed work load, 5% of PImax by using Threshold IMT.
Intervention Type
Device
Intervention Name(s)
Threshold (IMT)
Intervention Description
Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated.
Primary Outcome Measure Information:
Title
Timed Up and Go Test
Description
this is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair and sit down. During the test, the child is expected to wear their regular footwear and use any mobility aids that they would normally require.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Activities of daily living using with Pediatric Evaluation of Disability Inventory
Description
PEDI scale
Time Frame
6 weeks
Title
Pulmonary Function Test
Description
spirometry
Time Frame
6 weeks
Title
Respiratory muscle strength
Description
Mouth pressure device
Time Frame
6 weeks
Title
Functional exercise capacity
Description
six minute walk test
Time Frame
6 weeks
Title
Change in trunk control over time assessed with Trunk Control Measurement Scale
Description
Assessing change in trunk control
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 7-14 years Diagnosed to spastic cerebral palsy Gross Motor Function Classification System levels I or II. Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments Child are able to demonstrate sufficient co-operation and cognitive understanding participating Exclusion Criteria: Active medical condition impairment (pneumonia etc.) Do not accommodate the study Do not want to attempt the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bulent Elbasan, Phd
Organizational Affiliation
Gazi University
Official's Role
Study Chair
Facility Information:
Facility Name
Gazi University, Faculty of Health and Sciences, Department of Physiotherapy and Rehabilitation
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
We have no decided yet

Learn more about this trial

Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

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