Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Cerebral Palsy

Cerebral Palsy Spastic Diplegia Clinical Trial

Official title:

Effects of Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Child

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047756
• Other study ID #: REC/00123Mehrin Wadood
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2023
• Source: Riphah International University
• Contact: Ayesha Bashir, MS
• Phone: 03335256920
• Email: ayesha.bashir[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare effect in both intervention

Description:

In this study we will compare the effects of hippotherapy and swiss ball therapy. Our objectives of the study are To compare the effects of hippotherapy and Swiss ball training, to improve trunk control and balance on spastic diplegic cerebral palsy

Hypothesis:

Alternative hypothesis:

There will be significant difference between the effects of hippotherapy and Swiss ball training to improve trunk control and balance on spastic diplegic cerebral palsy

Null hypothesis:

There will be no significant difference between the effects of hippotherapy and Swiss ball training to improve trunk control and balance on spastic diplegic cerebral palsy. This study will include total 64 participants. Calculated by Open Epitool.64patients will be divided in to 2 groups with equal sample size through sealed envelop method. Group A will receive hippotherapy while group B will receive swiss ball therapy.

Group A Intervention:

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 and side to side direction to encourage active postural control, trunk strength, balance and trunk/pelvic dissociation.30 minutes with a frequency ranging from 4 sessions per week and the total duration of horseback riding 6 weeks .Position the child to sit on the ball and giving forward, backward and side to side movement 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.

Group B Intervention:

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 minutes for 6 weeks duration.

Trunk Control Will be measured by three outcome measures which include trunk control measurement scale ,gross motor function scale and pediatric balance scale. Intervention will be given for 6 weeks.Assesment will be done on baseline, after 3 and 6 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

Inclusion Criteria:• Children (male and female)

• 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

Exclusion Criteria:• Children with mental retardation,

• Epilepsy, other associated neurological disorders, other type of cerebral palsy,

• Attention deficit hyperactivity disorder and sensory issues(poor visual or hearing acuity)

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy Spastic Diplegia
• Muscle Spasticity

Intervention

Other:
• Hippotherapy
Patient will perform different movement of the trunk while sitting on a horse.
• Swiss Ball therapy
Patient will perform movements of trunk on swiss ball

Locations

Country	Name	City	State
Pakistan	Helping hand for relief and development	Dir	Khyberpakhtunkhuwa

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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