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Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rebound Therapy
Physical Therapy Program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Spastic cerebral palsy was determined according to the sample size calculation, was selected from the outpatient's clinic of the faculty of Physical Therapy Cairo University.
  • Level I according to the Gross Motor Function Classification System (GMFCS). Chronological age ranged from 5 to 11 years.
  • Height was above 1 meter.
  • Understand verbal command.
  • The degree of spasticity ranged from 1 to 1+ according to Modified Ashworth' Scale.

Rebound therapy using trampoline was used as the method of management in the study group in addition to the selected physical therapy program that was used in both groups, and the treatment sessions was provided in the out-patient clinic of the faculty of Physical Therapy Cairo University.

Exclusion Criteria:

  • Vertigo or dizziness.
  • Epilepsy.
  • Osteoporosis.

Sites / Locations

  • Faculty of Physical Therapy Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Study Group

Arm Description

Eighteen children with spastic CP will receive especially designed physical therapy program based on Neuro-Developmental treatment (NDT) approach with emphasis on exercise encourage independent standing, stretches exercises, strengthening exercises, approximation, enhancement and facilitation of gait patterning and ankle ROM exercises for one hour for 24 sessions

ighteen children with spastic CP will receive the same program that the control group received in addition to especially designed exercises using rebound therapy (Mini Trampoline) that include push up exercise, standing, squatting, single limb squatting, kneeling position, catching and throwing a ball over head in kneeling position, catching and throwing a ball over head in standing position, kicking the ball, broad jumping with assistance, jumping in place, for 1 hour three times per week for three successive months.

Outcomes

Primary Outcome Measures

Balance
Stationary Balance Using Biodex Balance System
Gross Motor Function
Gross Motor Function using Gross Motor Function Measure (GMFM)
Gross Motor Coordination
Gross Motor Coordination Using Gross Motor Coordination Quotient in BOT-2

Secondary Outcome Measures

Full Information

First Posted
January 4, 2021
Last Updated
January 13, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04712708
Brief Title
Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy
Official Title
Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Cerebral palsy (CP) is a group of disorders of movement and posture, causing several body impairments. CP is caused by non-progressive disturbance that occurred in the fetal or immature brain. CP symptoms include several motor disorders such as disturbances in sensation, coordination, cognition, communication and behavior in addition to disturbances in postural stability, balance and coordination. Balance is the ability to maintain the center of body mass over the base of support. CP causes balance impairment which results in decrease in the child's mobility functions and causing activity limitation and participations restrictions. Motor coordination is the registration of two or more things such as body movements , timing or sensory feedback into a harmonious relationship. CP causes disturbances in motor coordination such as difficulties in the routine gross movements as running and jumping, and disturbances in common fine movements like buttoning, clothing or brushing hair Rebound therapy is an exercise therapy which uses mini trampolines, rebounders , Springfree Trampoline and Swiss balls, to provide opportunity to perform recreational movements for individuals with different body structural and functional impairments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Eighteen children with spastic CP will receive especially designed physical therapy program based on Neuro-Developmental treatment (NDT) approach with emphasis on exercise encourage independent standing, stretches exercises, strengthening exercises, approximation, enhancement and facilitation of gait patterning and ankle ROM exercises for one hour for 24 sessions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
ighteen children with spastic CP will receive the same program that the control group received in addition to especially designed exercises using rebound therapy (Mini Trampoline) that include push up exercise, standing, squatting, single limb squatting, kneeling position, catching and throwing a ball over head in kneeling position, catching and throwing a ball over head in standing position, kicking the ball, broad jumping with assistance, jumping in place, for 1 hour three times per week for three successive months.
Intervention Type
Device
Intervention Name(s)
Rebound Therapy
Intervention Description
Rebound therapy is the therapeutic use of full sized trampoline or mini sized trampoline. It provides opportunities for exercise recreation and therapy; and it is distinct from gymnastic trampolining. It is used for facilitating movements, improving balance, enhancing coordination and promoting motor performances in children with different disorders includes learning disabilities, communication disorders and motor dysfunction (Rebound Therapy South Africa, 2020; The Chartered society of Physiotherapists, 2016).
Intervention Type
Other
Intervention Name(s)
Physical Therapy Program
Intervention Description
The Mat Exercises: Stretching exercises to all spastic muscle groups (Kalkman et al., 2018). Gentle exercises was applied for 40-60 seconds and repeated from 3-5 times/ movement as supported by (Fragala et al., 2003). Strengthening Exercises: Dynamic Rising Positioning The Gym Exercises:
Primary Outcome Measure Information:
Title
Balance
Description
Stationary Balance Using Biodex Balance System
Time Frame
12 Weeks
Title
Gross Motor Function
Description
Gross Motor Function using Gross Motor Function Measure (GMFM)
Time Frame
12 Weeks
Title
Gross Motor Coordination
Description
Gross Motor Coordination Using Gross Motor Coordination Quotient in BOT-2
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Spastic cerebral palsy was determined according to the sample size calculation, was selected from the outpatient's clinic of the faculty of Physical Therapy Cairo University. Level I according to the Gross Motor Function Classification System (GMFCS). Chronological age ranged from 5 to 11 years. Height was above 1 meter. Understand verbal command. The degree of spasticity ranged from 1 to 1+ according to Modified Ashworth' Scale. Rebound therapy using trampoline was used as the method of management in the study group in addition to the selected physical therapy program that was used in both groups, and the treatment sessions was provided in the out-patient clinic of the faculty of Physical Therapy Cairo University. Exclusion Criteria: Vertigo or dizziness. Epilepsy. Osteoporosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faten Abdelaziem, PhD
Phone
+20 100 855 4818
Email
faten.hassan@pt.cu.edu.eg
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faten Abdelaziem, PhD
Phone
+20 100 855 4818
Email
faten.hassan@pt.cu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Role of Rebound Therapy in the Rehabilitation of Children With Spastic Cerebral Palsy

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