The Effect of Hippotherapy Simulator in Children with Spastic Cerebral Palsy

NCT06404827 | Completed

• 1 other identifier: HKU-FTR-YK-1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; Horseback riding simulator; Selective motor control; Balance

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Intervention group (Horseback riding simulator+Routine physiotherapy)

EXPERIMENTAL

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.

Other: Horseback riding simulator; Other: Routine Physiotherapy and Rehabilitation

Control group (Routine physiotherapy)

ACTIVE COMPARATOR

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

Other: Routine Physiotherapy and Rehabilitation

Interventions

Horseback riding simulator OTHER

Horseback riding simulator (HRS) will be applied in addition to routine Physiotherapy and Rehabilitation.

Intervention group (Horseback riding simulator+Routine physiotherapy)

Routine Physiotherapy and Rehabilitation OTHER

Routine Physiotherapy and Rehabilitation within a spesific programme

Control group (Routine physiotherapy); Intervention group (Horseback riding simulator+Routine physiotherapy)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Gaziantep

Gaziantep, 27100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Yalçın Karabulut

  Hasan Kalyoncu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 8, 2024
• Study Start: February 20, 2024
• Primary Completion: November 20, 2024
• Study Completion: November 21, 2024
• Last Updated: January 15, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)