NCT06964386

Brief Summary

This was done to:

  1. 1.To determine the effect of a specially designed balance board on balance ability.
  2. 2.To determine the effect of the traditional balance training program on balance ability.
  3. 3.To compare between the effect of a specially designed balance board and the traditional balance training program on balance ability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2025

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

May 1, 2025

Last Update Submit

May 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of degree of spasticity

    Assessment of tone involves the clinician passively moving the patient's joints slowly and quickly and rating the degree of resistance felt to rapid stretch, typically as increased or decreased relative to a presumed normal (Hugos and Cameron, 2019). Only spastic diplegic children with grade 1 and 1+ will be included in the study

    at baseline and after 3 months

Secondary Outcomes (3)

  • Assessment of change of gross motor function level

    at baseline and after 3 months

  • assessment of change of balance

    at baseline and after 3 months

  • assessment of change of pediatric balance

    at baseline and after 3 months

Study Arms (2)

the traditional program

EXPERIMENTAL

twenty Children in group A received designed physical therapy program in addition to traditional balance training

Other: The traditional physical therapy rehabilitation exercisesOther: balance training on traditional balance board

balance training exercises

ACTIVE COMPARATOR

twenty Children in group B received the same designed physical therapy program in addition to balance training exercises on special form of balance board

Other: The traditional physical therapy rehabilitation exercisesOther: program on special form of balance board

Interventions

It included 30 minutes of exercises as: * Incorporated stretching (adductors, calf, and hamstring muscles) * Range of motion for hip, knee, and ankle joints. * Core stability exercises. * climbing stairs and weight-bearing activities for strengthening, such as sit-to-stand and attaining standing position by half kneeling

balance training exercisesthe traditional program

Balance training included: - Side stepping - Stepping backward - Changing the center of gravity in one-foot balance.

the traditional program

Standing holding on the sticks of balance board (first by two sticks, then graduated by one stick). 2- Changing the grasp of hand on sticks (reciprocal catching the sticks by right and left hand). 3- Stride standing on balance board. 4- Make exercises advanced by remove sticks and throwing the ball. 5- All previous exercises do with eye closed and eye opened

balance training exercises

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their ages ranged from 4 to 8 years old.
  • The degree of spasticity ranged from grade 1 or 1+ according to Modified Ashworth Scale
  • They were at level I or II on gross motor function classification scale.
  • They were able to follow verbal command or instructions.

You may not qualify if:

  • Children were excluded if they had one of the following :
  • Fixed deformities of lower limbs.
  • Visual or auditory problems.
  • History of surgical interference in lower limbs less than six months.
  • Botulinum toxin injections to the lower limb during the previous 4 months.
  • Mental retardation.
  • Fixed deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

out-patient clinic, faculty of physical therapy, Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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
principal investigator

Study Record Dates

First Submitted

May 1, 2025

First Posted

May 9, 2025

Study Start

January 1, 2023

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

May 9, 2025

Record last verified: 2025-05

Locations