search
Back to results

The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy

Primary Purpose

Cerebral Palsy, Spastic

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional physiotherapy including balance exercises
Inspiratory muscle training
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring Cerebral Palsy, Balance, Inspiratory Muscle Training, 6-Minute Walk Test, Pulmonary Function Test, Postural Stability

Eligibility Criteria

7 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cerebral palsy diagnosis
  • Children with level I or II according to Gross Motor Classification System

Exclusion Criteria:

  • Orthopedic surgery and / or Botox application in the lower extremity in the last 6 months
  • Severe convulsions that can not be controlled by drugs
  • Congenital malformation accompanying cerebral palsy

Sites / Locations

  • Bezmialem Vakif University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Training Group

Arm Description

Patients in this group will receive conventional physiotherapy programme including balance exercises, 3 times a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other 2 sessions will be performed at home.

In addition to conventional physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other sessions will be performed at home.

Outcomes

Primary Outcome Measures

Change from baseline maximum inspiratory pressure at 8 weeks
Change from baseline maximum expiratory pressure at 8 weeks
Change from baseline distance covered in six-minute walk test at 8 weeks
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks

Secondary Outcome Measures

Full Information

First Posted
January 5, 2018
Last Updated
June 27, 2018
Sponsor
Bezmialem Vakif University
search

1. Study Identification

Unique Protocol Identification Number
NCT03396289
Brief Title
The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy
Official Title
The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
June 25, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Cerebral palsy (CP) is a permanent, non-progressive disorder in which the immature brain is affected by various causes in the prenatal, perinatal or postnatal period. Damage to the central nervous system in children with CP causes motor problems, balance and postural disorders. It is reported in the literature that the effects of balance and the effects of balance exercises in children with CP, similarly respiratory effects were also investigated. Balance and balance responses are especially important in children with ambulatory SP and balance problems are seen in most CP children. Insufficient control of respiratory muscles affects pulmonary ventilation negatively in children with CP. However, it seems that CP has limited articles in which respiratory muscle strength is investigated, and also limited studies involving inspiratory muscle training. Inspiratory muscle training is shown to improve pulmonary function and diaphragm (which is one of the core muscles) strength and have an effect on balance. Studies showed that respiratory muscle strength in children with CP is lower than in children with normal development. Nevertheless, there was no study showing the effects of respiratory muscle training on functional capacity and balance in children with CP. The aim of this study is to investigate the effects of balance training and inspiratory muscle training on functional capacity, balance, respiratory function and respiratory muscle strength in children with CP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
Keywords
Cerebral Palsy, Balance, Inspiratory Muscle Training, 6-Minute Walk Test, Pulmonary Function Test, Postural Stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive conventional physiotherapy programme including balance exercises, 3 times a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other 2 sessions will be performed at home.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
In addition to conventional physiotherapy programme, patients in this group will also receive inspiratory muscle training for 15 minutes, twice a day, 7 days a week for 8 weeks. One exercise session will be performed under the supervision of a physiotherapist, other sessions will be performed at home.
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy including balance exercises
Intervention Description
Programme will include balance exercises with balance board and swiss ball, weight shifting exercises on board, one-legged balance, balance on unstable surface, balance on tilting surface and balance with Biodex Balance System. Biodex Balance System Biodex will only be used during sessions under physiotherapist supervision.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
Primary Outcome Measure Information:
Title
Change from baseline maximum inspiratory pressure at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline maximum expiratory pressure at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline distance covered in six-minute walk test at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline Peak Expiratory Flow (PEF) at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline postural stability test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks
Title
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cerebral palsy diagnosis Children with level I or II according to Gross Motor Classification System Exclusion Criteria: Orthopedic surgery and / or Botox application in the lower extremity in the last 6 months Severe convulsions that can not be controlled by drugs Congenital malformation accompanying cerebral palsy
Facility Information:
Facility Name
Bezmialem Vakif University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Effects of Balance and Respiratory Muscle Training on Functional Capacity, Balance, Respiratory Function and Respiratory Muscle Strength in Children With Cerebral Palsy

We'll reach out to this number within 24 hrs