Clinical trial NCT06003868: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Balance; Distorted
Walking, Difficulty
Keywords: Cerebral palsy
hippotherapy
walking
balance
life quality
diplegia
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pediatric Berg Balance Scale
timeFrame: 10 weeks
measure: Trunk Control Measurement Scale
timeFrame: 10 weeks
measure: 1 Minute Walk Test
timeFrame: 10 weeks
measure: Timed get up and go test
timeFrame: 10 weeks
measure: Functional independence measurement for children (WEEFIM)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tuzla
country: Turkey
facility: İşbir Hospital
state: İstanbul
Study officials:
affiliation: Uskudar University
name: Pelin GÜNEŞ
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.