NCT07438223

Brief Summary

Statement of the problem Do brain gym exercises affect balance and quality of life in children with spastic diplegia? Null hypotheses:

  1. 1.There will be no significant effect of brain gym exercises on balance in children with spastic diplegia.
  2. 2.There will be no significant effect of brain gym exercises on quality of life in children with spastic diplegia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

February 27, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 28, 2026

Last Update Submit

February 22, 2026

Conditions

Keywords

Brain gym exercisesCerebral palsyDiplegiaBalanceQuality of life

Outcome Measures

Primary Outcomes (2)

  • Balance

    Biodex balance system will measure the overall stability index, antero -posterior stability index and medio- lateral stability index, higher score indicate lower stability.

    3 months

  • Quality of life

    Cerebral Palsy Quality Of Life Questionnaire (CPQOL)contains 66 items each uses a 9- point rating scale ( for items The minimum value 1, maximum value 9)and then transformed to a 0 to 100 scale. As the total score approaches 100 this means better quality of life. The domains evaluated using it are social well being and acceptance, emotional well-being, function and participation and physical health, access to services, pain and impact of disability, and family health..

    3 months

Study Arms (2)

group A will take conventional physical therapy and brain gym exercises

EXPERIMENTAL

Group A will take conventional physical therapy for 45 minutes and brain gym exercises for 30 minutes for three months three sessions per week . Conventional physical therapy program includes: Balance from standing Sit to stand Standing balance One leg standing Ball kicking Reaching out Pick up objects outside the stability limit Gait training Walking sideways Walking backwards Obstacle course walking and stair climbing Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midlinemovements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump

Other: Brain gym exercisesOther: Conventional physical therapy program

Group B the control group will take only conventional physical therapy

EXPERIMENTAL

will take the same conventional physical therapy program for 45 minutes three times per week for three months.

Other: Conventional physical therapy program

Interventions

Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midline movements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump

group A will take conventional physical therapy and brain gym exercises

Conventional physical therapy program includes: Balance from standing Sit to stand Standing balance One leg standing Ball kicking Reaching out Pick up objects outside the stability limit Gait training Walking sideways Walking backwards Obstacle course walking and stair climbing Brain gym exercises include: Energy exercise: Drinking water Brain buttons Midlinemovements: Cross crawl Lazy eight Belly breathing exercise Deepening attitude: Hook- ups Lengthening activities: Arm activation The owl Calf pump

Group B the control group will take only conventional physical therapygroup A will take conventional physical therapy and brain gym exercises

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with spastic diplegia who have balance problems in standing and gait.
  • Degree of spasticity ranges from 1 and 1+, according to modified Ashworth scale (MAS) .
  • The age of children will range from 6 to 8 years old. 4-The height of children will be at least one meter. 5- Children are levels I and II according to GMFCS (Gross Motor Classification System ).

You may not qualify if:

  • Children with visual or auditory problems.
  • Children with intellectual disability.
  • Children have been injected with Botox injection or have done surgery in the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy cairo university

Cairo, Faculty of Physical Therapy, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hagar Mohamed Awaad, Assistant lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hebatallah Mohamed Kamal, Professor

CONTACT

Maya Galal Abd-Alwahab, Assistant professor

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
Assistant lecturer

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 27, 2026

Study Start

December 1, 2025

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-01

Locations