NCT07096531

Brief Summary

This study aims to investigate the effect of suit therapy combined with dual-task training on gross motor performance and walking abilities in children with diplegic cerebral palsy.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration 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

October 1, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

July 24, 2025

Last Update Submit

July 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Gross Motor Function Measure 88 (GMFM-88)

    The Gross Motor Function Measure (GMFM) 88 will be used to determine the severity of each case and to assess the child's motor performance in five dimensions: lying and rolling (17 items); sitting (20 items); crawling and kneeling (14 items); standing (13 items); and walking, running, and jumping (24 items). All items will be checked and scored before interpretation of the child's performance in each dimension. Scores of each dimension will be expressed as a percentage of the maximum scores for that dimension. The total score will be obtained by averaging the percentage scores across the five dimensions. Individual dimensions of GMFM-88 can be administered depending on the child's current level of function.

    3 months post-exercise

Secondary Outcomes (1)

  • Evaluation of balance using the Pediatric Balance Scale (PBS)

    3 months post-exercise

Study Arms (2)

Group (A)

ACTIVE COMPARATOR

Patients will receive suit therapy.

Other: Suit therapy

Group (B)

EXPERIMENTAL

Patients will receive suit therapy in addition to dual-task exercises.

Other: Suit therapy + Dual-task exercises

Interventions

Patients will receive suit therapy.

Group (A)

Patients will receive suit therapy in addition to dual-task exercises.

Group (B)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age from 6 to 12 years.
  • Both sexes.
  • A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists.
  • Children with spasticity grades ranged from 1 to 2+ according to the Modified Ashworth scale (MAS).
  • Children who can sit on the chair with good balance and recognize and follow verbal orders and commands are included in both testing and training techniques.

You may not qualify if:

  • They had a permanent deformity (bony or soft tissue contractures).
  • Children having visual or auditory defects.
  • Current hospitalization for urgent medical reasons.
  • Severe mental retardation.
  • Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey.
  • Children with a history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Waleed S Althobaiti, MBBCH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.Sc. in Physical Therapy, Faculty of Physical Therapy, Kafrelsheikh University, Kafrelsheikh, Egypt.

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

October 1, 2023

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations