NCT06047756

Brief Summary

To compare effect in both intervention

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

September 14, 2023

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Gross Motor Functional Scale

    Changes from baseline The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy.Greater score means higher functional level

    6weeks

  • Trunk Control Measurement Scale

    Changes from Baseline The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control, and 10 to the ability to perform dynamic reaching

    6 weeks

  • Pediatric Balance Scale

    Changes from Baseline Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points

    6 weeks

Study Arms (2)

Hippotherapy

EXPERIMENTAL

Patients suffering with diplegic therapy will perform their exercise protocols on a stationary horse.The child is seat astride the horse wearing a helmet and was encouraged to perform various activities designed to emphasize movement in a forward and upward reaching direction to encourage active postural control, trunk strength, balance and trunk/pelvic dissociation.30 minutes to 1 hour with a frequency ranging from 4 sessions per week and the total duration of horseback riding 6 weeks.

Other: Hippotherapy

Swiss Ball therapy

ACTIVE COMPARATOR

Children of second group will receive swiss ball therapy. Position the child to sit on the ball and giving extension rotation and flexion rotation to the child. This will facilitate trunk rotation by which the upper body is towards the weight bearing hip and away from the weight bearing hip.Training program 4 times per weeks with the treatment session of 30 minutes for 6 weeks duration

Other: Swiss Ball therapy

Interventions

Patient will perform different movement of the trunk while sitting on a horse.

Hippotherapy

Patient will perform movements of trunk on swiss ball

Swiss Ball therapy

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age group 4 to 11 years
  • Subject diagnosed with CP
  • Mild Spastic Diaplegic of the lower limbs according to the modified ashworth scale grade 1 to 1+
  • GMFM scale sitting balance score less than 20
  • Medically stable and able to understand commands

You may not qualify if:

  • Epilepsy, other associated neurological disorders, other type of cerebral palsy,
  • Attention deficit hyperactivity disorder and sensory issues(poor visual or hearing acuity)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping hand for relief and development

Dīr, Khyberpakhtunkhuwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Animal Assisted TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ayesha Bashir, MSNMPT

    Riphah international University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2023

First Posted

September 21, 2023

Study Start

March 1, 2023

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations