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

Primary Purpose

Cerebral Palsy Spastic Diplegia

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hippotherapy
Swiss Ball therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy Spastic Diplegia

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Helping hand for relief and developmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hippotherapy

Swiss Ball therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66) (12).
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
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

Secondary Outcome Measures

Full Information

First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06047756
Brief Title
Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Cerebral Palsy
Official Title
Effects of Hippotherapy Versus Swiss Ball Training to Improve Trunk Control and Balance on Spastic Daiplegic Child
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare effect in both intervention
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy Spastic Diplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Randomized
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hippotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Swiss Ball therapy
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Hippotherapy
Intervention Description
Patient will perform different movement of the trunk while sitting on a horse.
Intervention Type
Other
Intervention Name(s)
Swiss Ball therapy
Intervention Description
Patient will perform movements of trunk on swiss ball
Primary Outcome Measure Information:
Title
Gross Motor Functional Scale
Description
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. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66) (12).
Time Frame
6weeks
Title
Trunk Control Measurement Scale
Description
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
Time Frame
6 weeks
Title
Pediatric Balance Scale
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha Bashir, MS
Phone
03335256920
Email
ayesha.bashir@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Ayesha bashir Bashir
Phone
03335256920
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Bashir, MSNMPT
Organizational Affiliation
Riphah international University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helping hand for relief and development
City
Dīr
State/Province
Khyberpakhtunkhuwa
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Bashir, MSNMPT
Phone
03335256920
Email
ayesha.bashir@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Mehrin Wadood, DPT

12. IPD Sharing Statement

Plan to Share IPD
No

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

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