NCT07129785

Brief Summary

This randomized clinical trial aims to compare the effects of Dynamic Surface Exercise Training (DSET) and Static Surface Exercise Training (SSET) on balance and gross motor function in children with spastic diplegic cerebral palsy (CP) aged 6-12 years, classified at Gross Motor Function Classification System (GMFCS) levels III-IV. CP is the most common motor disability of childhood, characterized by non-progressive disturbances to the developing brain, leading to impairments in movement, posture, and functional independence. Balance deficits and gross motor limitations significantly impact daily activities and quality of life in these children. Dynamic surfaces such as Swiss balls, bolsters, and platform swings provide postural perturbations that challenge vestibular, proprioceptive, and visual systems, potentially enhancing trunk control, postural stability, and adaptive responses. In contrast, static surface exercises emphasize controlled strength, postural alignment, and functional task performance on stable platforms such as mats or benches. Fifty participants meeting the inclusion criteria will be randomly allocated into two equal groups. The DSET group will receive 60-minute sessions, four days per week for six weeks, involving multi-planar trunk activation, optimal arousal activities, and dynamic balance tasks on unstable surfaces. The SSET group will perform equivalent-duration exercises on stable surfaces, focusing on functional reaching, transfers, and static/dynamic balance. Primary outcomes are Gross Motor Function Measure-66 (GMFM-66) and Pediatric Balance Scale (PBS), assessed at baseline, week 3, and week 6 by a blinded evaluator. Statistical analyses will compare within- and between-group changes. Findings will help identify the more effective approach for improving functional outcomes in children with CP, guiding evidence-based pediatric neurorehabilitation strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

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

February 15, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2025

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 11, 2025

Last Update Submit

August 31, 2025

Conditions

Keywords

Dynamic Surface Exercise TrainingStatic Surface Exercise TrainingSwiss Ball TherapyPediatric NeurorehabilitationPostural ControlGross Motor Function MeasurePediatric Balance ScaleTrunk ControlMotor Skill DevelopmentUnstable Surface TrainingStable Surface Training

Outcome Measures

Primary Outcomes (2)

  • Gross Motor Function Measure-66 (GMFM-66) Score

    The GMFM-66 is a standardized observational instrument used to assess gross motor function in children with cerebral palsy. It evaluates the child's ability to perform various motor tasks across lying, sitting, crawling, standing, and walking dimensions. Scores range from 0 to 100, with higher scores indicating better motor performance. Assessments will be conducted by a blinded evaluator at baseline, week 3, and week 6 to determine within- and between-group changes following Dynamic Surface Exercise Training or Static Surface Exercise Training.

    Baseline, Week 3, Week 6

  • Pediatric Balance Scale (PBS) Score

    The PBS is a 14-item scale adapted from the Berg Balance Scale to assess static, dynamic, and functional balance in children aged 3-13 years. Each item is scored from 0 to 4, with total scores ranging from 0 to 56. Higher scores reflect better balance and postural control. A blinded evaluator will assess participants at baseline, week 3, and week 6 to measure improvement in balance performance after the assigned intervention.

    Baseline, Week 3, Week 6

Study Arms (2)

Dynamic Surface Exercise Training (DSET)

EXPERIMENTAL

Participants in this group will receive Dynamic Surface Exercise Training for 60 minutes per session, four days per week, for six weeks. Activities include optimal arousal (active/passive bouncing) on Swiss/gym balls or trampolines, multi-planar trunk activation, high sitting with one- and two-hand reaching, sit-to-stand transitions, and dynamic balance tasks performed on unstable surfaces such as bolsters and platform swings. Exercises are designed to challenge vestibular, proprioceptive, and visual systems to enhance gross motor function and balance.

Behavioral: Dynamic Surface Exercise Training (DSET)

Static Surface Exercise Training (SSET)

ACTIVE COMPARATOR

Participants in this group will receive Static Surface Exercise Training for 60 minutes per session, four days per week, for six weeks. Activities include transfers between sitting and quadruped, high sitting on a bench with functional reaching, static and dynamic balance in standing, ball-catching and kicking, and trunk activation tasks performed on stable surfaces such as mats or benches. Exercises aim to improve gross motor function and balance through controlled, stable postural activities.

Behavioral: Static Surface Exercise Training (SSET)

Interventions

DSET involves performing multi-planar trunk activation, postural control, and balance exercises on unstable surfaces such as Swiss/gym balls, bolsters, trampolines, and platform swings. Each session lasts 60 minutes, four times per week, for six weeks. Activities include optimal arousal (bouncing), high sitting with one- and two-hand reaching, sit-to-stand transitions, and lateral weight-shifting. The unstable surface provides postural perturbations that stimulate vestibular, proprioceptive, and visual systems to improve gross motor function and balance in children with spastic diplegic cerebral palsy.

Dynamic Surface Exercise Training (DSET)

SSET consists of functional strength, posture, and balance exercises performed on stable surfaces such as mats, benches, or stools. Each session lasts 60 minutes, four times per week, for six weeks. Activities include transfers between sitting and quadruped, high sitting with functional reaching, static and dynamic standing balance, ball-catching and kicking, and trunk activation tasks. Exercises aim to enhance gross motor function and balance through controlled, stable postural activities in children with spastic diplegic cerebral palsy.

Static Surface Exercise Training (SSET)

Eligibility Criteria

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

You may qualify if:

  • Children diagnosed with spastic diplegic CP between age 6-12 years (Reddy \& Balaji, 2020).
  • Both male and female gender (Reddy \& Balaji, 2020).
  • Who were able to follow verbal commands.
  • Children having level III and IV of Gross Motor Function Classification System (GMFCS) (Reddy \& Balaji, 2020).

You may not qualify if:

  • CP Child who were reluctant to cooperate.
  • CP child having visual or intellectual impairments (Reddy \& Balaji, 2020).
  • Who were on Antiepileptic medications (Reddy \& Balaji, 2020).
  • CP child having any cardiac or chest anomalies and hearing deficits.
  • Exercise intolerance and any recent orthopedic surgery will also be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

Location

MeSH Terms

Conditions

Cerebral PalsyCerebral palsy, spastic, diplegic

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
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

August 11, 2025

First Posted

August 19, 2025

Study Start

February 15, 2025

Primary Completion

August 22, 2025

Study Completion

August 29, 2025

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations