NCT05739396

Brief Summary

the study aims to compare the effect of core stabalization and rebound therapy on balance in children with hemiplegic cerebral palsy

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
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

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

February 1, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 13, 2023

Last Update Submit

February 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • balance

    it measures the degree of tilting for each axis during dynamic conditions and calculates a medial lateral stability index (MLSI); an anterior-posteriorstability index (APSI); and an overall stability index(OSI),

    12 week

Secondary Outcomes (3)

  • gross motor function measure-88

    12 week

  • lafayette hand held dynamometer

    12 week

  • 6 minute walk test

    12 week

Study Arms (2)

core stabalization

EXPERIMENTAL

The core stability exercises will be used for core stabilization training of group (A) in addition to traditional physical therapy. The core stability program included 3 levels. Each exercise lasted 5 min, and the children shifted from one exercise to the next after the complete performance of the preceding exercise. The first (simple) level included supine abdominal draw-in (20 repetitions), abdominal draw-in with both knees to the chest (10-20 repetitions), and supine twist (10-20 repetitions). The second (medium) level included pelvic bridging (3e5 repetitions) and twist with a medicine ball (10e20 repetitions). Finally, the third (difficult) level included bridging with the head on a physio ball (the position was held for 3-5 s, followed by a slow relaxation phase, with 10-20 repetitions)

Other: core stabilization

rebound therapy

EXPERIMENTAL

Rebound exercises will be applied for group B. this group will receive rebound exercise training in addition to traditional physical therapy . Rebound exercises were conducted on a mini-trampoline and BOSU ball. Passive bouncing will be conducted while the child was standing with his/her feet a shoulder-width apart. The therapist will held the child's legs while applying upward and downward movement. The bouncing started slowly. The child then will progress to include the rebound exercises, starting with active bounce, where in a hands free manner the therapist will ask the child to speed up or slow down the bounce rate according to the child's abilities

Other: core stabilization

Interventions

The treatment session lasted one hour with short breaks of around 10 minutes and will be conducted three times per week for twelve successive weeks

Also known as: rebound therapy
core stabalizationrebound therapy

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children diagnosed with spastic hemiplegic CP.
  • Their chronological age ranged from 5 to 8 years,
  • able to follow verbal commands or instructions during testing procedures,
  • degree of spasticity in affected lower limbs ranged between1 to 1+ according to Modified Ashworth scale (MAS),
  • they are able to understand and follow instructions given to them,

You may not qualify if:

  • Children who had significant visual or auditory problems that may interfere with testing, - ---- patients who had contractures or fixed deformities related to the joints of the lower limbs, ---- injection with Botulinium toxin or any orthopaedic surgery in lower limbs 6m before study,
  • children who were suffering from cardiopulmonary problems or epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty Of Physical Therapy

Cairo, Egypt

Location

Related Publications (1)

  • Al-Nemr A, Kora AN. Effect of core stabilization versus rebound therapy on balance in children with cerebral palsy. Acta Neurol Belg. 2024 Jun;124(3):843-851. doi: 10.1007/s13760-023-02430-8. Epub 2024 Jan 5.

Study Officials

  • Faculty OP Therapy

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer in pediatric department, faculty of physical therapy

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 22, 2023

Study Start

February 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 11, 2023

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations