NCT07854054

Brief Summary

This study will compare the effects of pilates exercise and swiss ball training on trunk control, balance and gait in children with diplegic cerebral palsy. This study will be a randomized clinical trial including 62 participants, who will be allocated into two groups. Both groups will receive their respective interventions thrice a week for 12 weeks. The participants will be evaluated at the start and end of the exercise program through The Trunk Control Measurement Scale (TCMS), Pediatric Berg Balance measurement (PBBM), Pediatric Reach Test (PRT) and Observational Gait Scale (OGS) will be used to assess the effect of this intervention on trunk control, balance and gait.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

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

June 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 27, 2026

Last Update Submit

September 27, 2026

Conditions

Keywords

Cerebral PalsyPilates Core Strengthening ExerciseSwiss Ball ExerciseBalanceGaitTrunk Control

Outcome Measures

Primary Outcomes (1)

  • Trunk Control

    Assessed using the Trunk Control Measurement Scale

    [Time Frame: Baseline and 12 weeks post-intervention]

Secondary Outcomes (2)

  • Balance

    [Time Frame: Baseline and 12 weeks post-intervention]

  • Gait

    [Time Frame: Baseline and 12 weeks post-intervention]

Study Arms (2)

Pilates Exercise Training Group

EXPERIMENTAL

Pilates Exercise Training Group Participants will receive pilates exercise training over 12 weeks, with increasing sets and repetitions. Each session will begin with a 5-minute warm-up and end with a 5-minute cooldown. Outcome will be assessed at baseline and after 12 weeks.

Other: Pilates Exercise Training

Swiss Ball Exercise Training

ACTIVE COMPARATOR

Swiss Ball Exercise Group Participants will receive swiss ball exercises for 12 weeks, with increasing sets and repetitions. After this, go to Interventions and add Pilates Exercise and Swiss Ball Training, then assign each intervention to its matching arm.

Other: Swiss Ball Exercise Training

Interventions

Pilates Exercise Training Pilates Exercise Training Group Participants in this arm will receive prone bridge, shoulder bridge, unilateral shoulder bridge, side bridge, hundreds, leg pull supine, mermaid side stretch, and side laying clam. These exercises will be progressed over 12 weeks, with increasing sets and repetitions. Each session will begin with a 5-minute warm-up and end with a 5-minute cooldown. Treatment will be supervised by a physiotherapist, and outcomes will be assessed at baseline and after 12 weeks

Also known as: PSCS, Pilates Core Strengthening Exercise
Pilates Exercise Training Group

Swiss Ball Exercise Participants in this arm will receive seated positioning, diagonal movement, trunk rotation, hip flexion and extension, lifting buttocks, weight shifting, prone arm extension, and rolling to sit. These exercises will also be progressed over 12 weeks, with increasing sets and repetitions. Modifications and considerations will be made to ensure the child's safety and individual needs. Outcomes will be assessed at baseline and after 12 weeks.

Also known as: GYM Ball exercises
Swiss Ball Exercise Training

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 7 and 14 years old both male and female
  • Children diagnosed with diplegic cerebral palsy will be recruited.
  • Able to perform sit-to-stand task and walking with or without assistance having full range of motion. Children with GMFCS Level I, II and III Because they all have some level of walking ability, even if they need assistance (like a Walker or Crutches).
  • Children who have score above 45 on Pediatric Berg Balance Scale will be recruited.
  • The children were cognitively qualified and capable of understanding and following instructions and having less than 24 score on mini mental state examination.

You may not qualify if:

  • Patients with fixed contracture.
  • Spinal or limb malformations.
  • Visual or respiratory disorders.
  • Injection of botulinum toxin into the lower limb muscles during the previous 6 months were all excluded.
  • Children with GMFCS Level IV and V because they cannot walk independently or even with assistive devices. They depend on powered or manual wheelchair.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hafiz Physiotherapy Center

Gujrat, Punjab Province, 50700, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Fatima Tariq

    Riphah International University Role

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
A single-blinded design will be implemented: the outcome assessor will remain blinded to group allocation to minimize measurement bias and enhance the reliability of results.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated into two equal groups: Pilates Exercise Training Group and Swiss Ball Exercise Group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2026

First Posted

October 2, 2026

Study Start

June 1, 2025

Primary Completion

July 6, 2026

Study Completion

August 6, 2026

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

The individual participant data sharing plan has not yet been finalized.

Locations