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

Primary Purpose

Cerebral Palsy, Balance; Distorted, Walking, Difficulty

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
traditional physiotherapy
hippotherapy-assisted physiotherapy
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, hippotherapy, walking, balance, life quality, diplegia

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • İşbir HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

hippotherapy group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06003868
Brief Title
Investigation of the Effect of Hippotherapy Simulator in Children With Spastic Diplegia and Cerebral Palsy
Official Title
Investigation of the Effect of Hippotherapy Simulator on Balance and Walking in Children With Spastic Diplegia Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar 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
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.
Detailed Description
Patients diagnosed with spastic diplegia cerebral palsy in the study; It will be classified according to Gross Motor Function Classification System (KMFSS). The Trunk Control Measurement Scale will be used to assess trunk control. Pediatric Berg Balance Scale will be used to assess balance. The 1 Minute Walk Test and the Timed Get Up and Go test will be used to assess walking. The WEEFIM scale will be used to assess quality of life. The study sample will be divided into two groups. The first group will receive 45 minutes of conventional physical therapy. In addition to 45 minutes of physical therapy, the other group will receive 15 minutes of hippotherapy simulator. The results will be compared at the beginning and end of the study. Then, individuals will be divided into two groups with a simple randomized method. Traditional physical therapy will be applied to the control group for 45 minutes, 2 days a week, for 8 weeks. In addition to traditional physical therapy, 15 minutes of therapy training with a hippotherapy device will be applied to the experimental group. Evaluation tests will be repeated at the beginning and end of the study. Pre- and post-intervention data were statistically analyzed and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Balance; Distorted, Walking, Difficulty
Keywords
Cerebral palsy, hippotherapy, walking, balance, life quality, diplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
Physiotherapy will be applied for 8 weeks, 2 days a week, as one session per day (45 minutes).
Arm Title
hippotherapy group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
traditional physiotherapy
Intervention Description
Stretching for patients with spasticity exercises walking exercises for balance and gait disorders muscle strengthening exercises relaxation exercises
Intervention Type
Other
Intervention Name(s)
hippotherapy-assisted physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pediatric Berg Balance Scale
Description
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.
Time Frame
10 weeks
Title
Trunk Control Measurement Scale
Description
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.
Time Frame
10 weeks
Title
1 Minute Walk Test
Description
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.
Time Frame
10 weeks
Title
Timed get up and go test
Description
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.
Time Frame
10 weeks
Title
Functional independence measurement for children (WEEFIM)
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pelin GÜNEŞ
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
İşbir Hospital
City
Tuzla
State/Province
İstanbul
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32961681
Citation
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.
Results Reference
background
PubMed Identifier
32138777
Citation
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.
Results Reference
background
PubMed Identifier
35184078
Citation
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.
Results Reference
background
PubMed Identifier
32086598
Citation
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.
Results Reference
background
PubMed Identifier
34206816
Citation
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.
Results Reference
background

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

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