The Effect of Hippotherapy Simulator in Children With Spastic Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Investıgatıon of the Effect of Hıppotherapy Sımulator on Lower Extremıty Selectıve Motor Control, Balance and Trunk Control in Chıldren Wıth Spastıc Cerebral Palsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404827
• Other study ID #: HKU-FTR-YK-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Hasan Kalyoncu University
• Contact: Yalçin Karabulut
• Phone: +90342 211 80 81
• Email: y.karabulut_[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Other:
• Horseback riding simulator
Horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation.
• Routine Physiotherapy and Rehabilitation
Routine Physiotherapy and Rehabilitation within a spesific programme

Locations

Country	Name	City	State
Turkey	Gaziantep	Gaziantep

Sponsors (1)

Lead Sponsor	Collaborator
Hasan Kalyoncu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Motor Function Classification System (GMFCS)	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.	At Baseline
Primary	Manuel ability classification system (MACS)	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.	At Baseline
Primary	Change from Baseline Selective Control Assessment of the Lower Extremity 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 at 8 weeks
Primary	Change from Baseline Pediatric balance scale 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.	Change from Baseline at 8 weeks
Primary	Change from Baseline Trunk Control Measurement Scale 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 at 8 weeks
Primary	Change from Baseline Modified Ashworth Scale (MAS) 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.	Change from Baseline at 8 weeks