NCT04712708

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

January 15, 2021

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

January 4, 2021

Last Update Submit

January 13, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Balance

    Stationary Balance Using Biodex Balance System

    12 Weeks

  • Gross Motor Function

    Gross Motor Function using Gross Motor Function Measure (GMFM)

    12 Weeks

  • Gross Motor Coordination

    Gross Motor Coordination Using Gross Motor Coordination Quotient in BOT-2

    12 Weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Other: Physical Therapy Program

Study Group

EXPERIMENTAL

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.

Device: Rebound TherapyOther: Physical Therapy Program

Interventions

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).

Study Group

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:

Control GroupStudy Group

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Vertigo or dizziness.
  • Epilepsy.
  • Osteoporosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy Cairo University

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Faten Abdelaziem, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof . Dr

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 15, 2021

Study Start

November 1, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

January 15, 2021

Record last verified: 2020-12

Locations