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

NCT ID: NCT06003868

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2023-12-20

Brief Summary

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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

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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.

Conditions

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Cerebral Palsy Balance; Distorted Walking, Difficulty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

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

Group Type ACTIVE_COMPARATOR

traditional physiotherapy

Intervention Type OTHER

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

hippotherapy group

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.

Group Type EXPERIMENTAL

traditional physiotherapy

Intervention Type OTHER

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

hippotherapy-assisted physiotherapy

Intervention Type 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.

Interventions

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traditional physiotherapy

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

Intervention Type OTHER

hippotherapy-assisted physiotherapy

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uskudar University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Öğr. Üyesi Ömer Şevgin

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pelin GÜNEŞ

Role: STUDY_CHAIR

Uskudar University

Locations

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İşbir Hospital

Tuzla, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32961681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32138777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35184078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32086598 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34206816 (View on PubMed)

Other Identifiers

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Uskudar72

Identifier Type: -

Identifier Source: org_study_id

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