Investigation of the Effect of Hippotherapy Simulator in Children With Spastic Diplegia and Cerebral Palsy

NCT06003868 | Completed

• 1 other identifier: Uskudar72
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to examine the effect of hippotherapy simulator on trunk control, balance and gait in children with spastic diplegia cerebral palsy and its relationship with quality of life.

Conditions

Cerebral Palsy; Balance; Distorted; Walking, Difficulty

Keywords

Cerebral palsy; hippotherapy; walking; balance; life quality; diplegia

Outcome Measures

Primary Outcomes (5)

• Pediatric Berg Balance Scale

  Berg Balance Scale was designed for children to evaluate functions in activities of daily living. version. The scale consists of 14 assessments and each section is scored between 0-4; The highest possible score is 56.

  10 weeks

• Trunk Control Measurement Scale

  For this reason, the scale consists of two parts: Static Sitting Balance (SSB) and Dynamic Sitting Balance (DSB). The DSB section also consists of two sub-parameters as selective motion control and dynamic reach. While the static sitting balance subscale evaluates static trunk control during lower and upper extremity movements, the selective motion control subscale evaluates selective trunk movements in three planes (flexion/extension, rotation, and lateral flexion). The dynamic reach subscale evaluates performance during reaching tasks that require active trunk movement. The scale consists of 15 items in total (subscales 5, 7 and 3 items, respectively). Items are scored on a 2, 3, and 4-point ordinal scale and are administered bilaterally when clinically significant. While the total score of the scale varies between 0-58 points, higher scores indicate a better performance.

  10 weeks

• 1 Minute Walk Test

  First, the child puts on his own clothes and shoes. He is allowed to use his splints and suitable walking aid. At least 5 minutes before starting the test. He is allowed to rest and then brought to the starting point of the path he will walk. When the command is given, it is said to start walking as fast as possible for 1 minute. It is also reported that he is not allowed to run. The distance is then calculated.

  10 weeks

• Timed get up and go test

  It is a test used to measure mobility and assesses walking speed, postural control, functional mobility and balance. The Timed Get Up and Go Test measures the time it takes for a person to get up from an arm-supported chair, turn by walking 3 m, and walk back to the chair, then sit down. The time it takes to get up from the chair and sit back on the chair is recorded.

  10 weeks

• Functional independence measurement for children (WEEFIM)

  It was developed to assess the level of functional independence of children with a physical disability and consists of three main categories and a total of 18 questions. A total of 18 questions under the heading of self-care, mobility and cognitive function categories are scored between 1 and 7. According to this; While performing the function to be evaluated, the child with a physical disability gets 1 point if he/she does it completely with assistance, and 7 points if he/she does it completely independently. The lowest score that the child can get from the scale is 18, and the highest score is 126.

  10 weeks

Study Arms (2)

control group

ACTIVE COMPARATOR

Physiotherapy will be applied for 8 weeks, 2 days a week, as one session per day (45 minutes).

Other: traditional physiotherapy

hippotherapy group

EXPERIMENTAL

Physiotherapy will be applied for 8 weeks, 2 days a week, one session a day (45 minutes). In addition, the patients will be placed on the simulator and the starting position will be taught. your simulator They will be warned before and during the application to maintain the starting position throughout their movements. pattern and will be run in the 1st stage of the 3-stage speed level.

Other: traditional physiotherapy; Other: hippotherapy-assisted physiotherapy

Interventions

traditional physiotherapy OTHER

Stretching for patients with spasticity exercises walking exercises for balance and gait disorders muscle strengthening exercises relaxation exercises

control group; hippotherapy group

hippotherapy-assisted physiotherapy OTHER

The patients will be placed on the simulator and the starting position will be taught. your simulator before the application and in order to maintain the starting position throughout their movements. they will be warned during the applications.. Hippotherapy simulator is almost like walking. pattern and will be run in the 1st stage of the 3-stage speed level.

hippotherapy group

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diplegic Cerebral Palsy between the ages of 4 and 16
• Levels 1,2 and 3 according to KMFSS
• Have not had botox or surgery in the last 6 months
• Able to perceive simple commands
• Patients who can sit in the hippotherapy simulator will be included.

You may not qualify if:

• With hip dislocation
• Those with hearing or visual disabilities
• Those who do not want to be involved in the study
• Adductor spasticity is stage 3 and above according to the ashworth spasticity scale.
• With upper extremity amputation

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

İşbir Hospital

Tuzla, Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Matusiak-Wieczorek E, Dziankowska-Zaborszczyk E, Synder M, Borowski A. The Influence of Hippotherapy on the Body Posture in a Sitting Position among Children with Cerebral Palsy. Int J Environ Res Public Health. 2020 Sep 19;17(18):6846. doi: 10.3390/ijerph17186846.

  PMID: 32961681 BACKGROUND

• Hausler M, Heussen N. Protocol for a systematic review and meta-analysis on the effect of hippotherapy and related equine-assisted therapies on motor capabilities in children with cerebral palsy. Syst Rev. 2020 Mar 5;9(1):48. doi: 10.1186/s13643-020-01297-7.

  PMID: 32138777 BACKGROUND

• Hyun C, Kim K, Lee S, Ko N, Lee IS, Koh SE. The Short-term Effects of Hippotherapy and Therapeutic Horseback Riding on Spasticity in Children With Cerebral Palsy: A Meta-analysis. Pediatr Phys Ther. 2022 Apr 1;34(2):172-178. doi: 10.1097/PEP.0000000000000880.

  PMID: 35184078 BACKGROUND

• Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.

  PMID: 32086598 BACKGROUND

• Apolo-Arenas MD, Jeronimo AFA, Cana-Pino A, Fernandes O, Alegrete J, Parraca JA. Standardized Outcomes Measures in Physical Therapy Practice for Treatment and Rehabilitation of Cerebral PALSY: A Systematic Review. J Pers Med. 2021 Jun 26;11(7):604. doi: 10.3390/jpm11070604.

  PMID: 34206816 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Mobility Limitation

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pelin GÜNEŞ

  Uskudar University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Exercises with Hippotherapy Simulator: This exercise will be applied to the group for 8 weeks, 2 days a week, as a single session (15 minutes) a day. The patients will be placed on the simulator and the starting position will be taught. They will be warned to maintain the starting position throughout the movements of the simulator. The hippotherapy simulator will be operated almost in the gait pattern of the horse and in the 1st stage of the 3-stage speed level. If the patients have unusual complaints such as dizziness, blackout, chest pain and risk of falling during the application. they will be advised to request to stop the application

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 22, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 20, 2023
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)