The Effect of Hippotherapy Simulator in Children with Spastic Cerebral Palsy

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Other: Horseback riding simulator; Other: Routine Physiotherapy and Rehabilitation

• Registration Number: NCT06404827
• Lead Sponsor: Hasan Kalyoncu University

Brief Summary

The horseback riding simulator (HRS) is a dynamic robotic device that mimics the movement of a horse for hippotherapy purposes. HRS aims to improve the patient's balance, adaptation and provide postural adjustment by mimicking the rhythmic movements of the horse.

This study aims to research the potential benefits of the horseback riding simulator on the lower extremity selective motor control, balance and trunk control in children with Cerebral palsy.

Detailed Description

Between the dates of the study, children with Cerebral palsy (CP) who meet the inclusion criteria will be allocated into two groups (intervention group, control group) by randomiZation method.

Intervention group: horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation. This group will receive 20 minutes of routine physiotherapy training and 20 minutes of HRS application in addition to 2 sessions per week for 8 weeks.

Control group: Routine physiotherapy training will be applied within a specific programme for 40 minutes in 2 sessions per week for 8 weeks.

All the assessments will be performed before and after the training in the 8-week groups.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-20
• Study First Submitted: 2024-05-05
• Study First Submitted QC: 2024-05-05
• Study First Posted: 2024-05-08
• Primary Completion: 2024-11-20
• Study Completion: 2024-11-21
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Diagnosis of Spastic Cerebral Palsy
• Voluntary participation
• Age between 5-17 years,
• GMFCS Level I-II-III
• MACS Level I-II-III
• Modified Asworth Scale (MAS) Level 1-2-3
• Have the ability to sit with support

Exclusion Criteria

• Having severe visual and hearing problems
• Severe distractibility problems and inability to follow task instructions,
• Not voluntary to participate in the research,
• Individuals with CP who have had hip or spine surgery in the last 6 months
• Individuals with CP who have undergone Botox in the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group (Horseback riding simulator+Routine physiotherapy)	Horseback riding simulator	Horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation. This group will receive 20 minutes of routine physiotherapy training and 20 minutes of HRS application in addition to 2 sessions per week for 8 weeks.
Intervention group (Horseback riding simulator+Routine physiotherapy)	Routine Physiotherapy and Rehabilitation	Horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation. This group will receive 20 minutes of routine physiotherapy training and 20 minutes of HRS application in addition to 2 sessions per week for 8 weeks.
Control group (Routine physiotherapy)	Routine Physiotherapy and Rehabilitation	Routine physiotherapy training will be applied within a specific programme for 40 minutes in 2 sessions per week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Manuel ability classification system (MACS)	At Baseline	Classify how children with CP use their hands when dealing with objects in daily activities. It is a 5-level classification scale. The higher the level, the worse the manual ability. Level 1 means that objects can be handled and used easily and successfully. Level 5 refers to being unable to handle and use objects and having severely limited ability to perform even simple activities.
Change from Baseline Trunk Control Measurement Scale at 8 weeks	Change from Baseline at 8 weeks	This scale consists of two main parts, dynamic and static sitting balance, and provides an assessment. The scale consists of 15 items. Items are scored as 0, 1, 2 or 3. The minimum score that can be obtained from the scale is 0 and the maximum score is 58. A higher score indicates better trunk control.
Change from Baseline Modified Ashworth Scale (MAS) at 8 weeks	Change from Baseline at 8 weeks	This scale is the most widely used clinical scale to assess spasticity. It is a 6-point scale that assesses muscle tone by passively moving the joint through the normal range of possible motion and recording resistance to passive movement. The scoring ranges from 0-5. There is no tonus increase at 0. 5 indicates that the affected limb is rigid. The higher the score, the greater the increase in tonus.
Gross Motor Function Classification System (GMFCS)	At Baseline	Assessing functional level and gross motor function of children with CP. Level I refers to a child walking independently, while level V refers to mobility with a wheelchair.
Change from Baseline Selective Control Assessment of the Lower Extremity at 8 weeks	Change from Baseline at 8 weeks	Evaluates the lower extremity selective motor control of individuals with CP. The scale assesses five joints separately and bilaterally: hip, knee, ankle, subtalar joint and toe. The degree of selective motor control is determined for each joint as 'normal' (2 points), 'impaired' (1 point) or 'unable to perform' (0 points), according to the patient's ability to perform the movements. The total score is obtained by summing the scores from the joint levels for each limb, with a maximum score of 10 points. Low scores indicate poor selective motor control.
Change from Baseline Pediatric balance scale at 8 weeks	Change from Baseline at 8 weeks	Assesses the balance of children with CP. This scale consists of 14 items, each of which is scored from 0 to 4. A score of 0 indicates that he/she cannot carry out the instruction and a score of 4 indicates that he/she can do it without difficulty. The total score ranges from 0-56. A low total score indicates a decrease in balance function.

Trial Locations

Locations (1)

Gaziantep; 🇹🇷 Gaziantep, Turkey