NCT06231147

Brief Summary

Spastic cerebral palsy is a neurological condition that causes muscle spasticity and motor impairments, greatly impacting a child's ability to maintain balance and control their posture. The horse riding simulator (HRS), inspired by hippo therapy, has emerged as a potential therapeutic intervention for enhancing motor function in individuals with cerebral palsy. This study explored the additional effects of mirror visual feedback when used in conjunction with the HRS. Strategically placed mirrors allow participants to observe their own body movements and positions in real-time. The simulator's rhythmic, multidimensional movements deliver sensory input and challenge the motor system, promoting postural adjustments and improved balance. Furthermore, the integration of mirror visual feedback appears to enhance the therapeutic benefits. Real-time visual information enables children to actively observe and correct their body positioning, leading to improved body awareness and more efficient motor responses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

June 13, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

December 26, 2023

Last Update Submit

June 11, 2024

Conditions

Cerebral Palsy

Keywords

BalanceCerebral PalsyHorse Riding Simulator (HRS)Posture Control

Outcome Measures

Primary Outcomes (2)

  • Pediatric balance scale

    The Pediatric Balance Scale is assessment tool specifically designed to evaluate balance in children. It has been extensively used in clinical and research settings to assess balance impairments and monitor progress over time.

    8 weeks

  • Posture and postural ability scale

    Posture and Postural Ability Scale is an assessment tool that allows for posture and postural ability to be assessed independently

    8 weeks

Study Arms (2)

Group A

EXPERIMENTAL

horse riding simulator sessions with mirror visual feedback

Other: HORSE RIDING SIMULATOR WITH VISUAL FEEDBACK

Group B

OTHER

horse riding simulator sessions without mirror visual feedback

Other: HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACK

Interventions

HORSE RIDING SIMULATOR WITH VISUAL FEEDBACKOTHER

horse riding simulator session with mirror visual feedback. The participants will be instructed that how to perform exercises by using the horse riding simulator (HRS) system in front of mirror

Group A
HORSE RIDING SIMULATOR WITHOUT VISUAL FEEDBACKOTHER

horse riding simulator session without visual feedback. The participants will be instructed that how to perform exercises by using the horse riding simulator (HRS) system.

Group B

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spastic cerebral palsy with level I and II according to Gross Motor Function Classification System (GMFCS)
  • Age between 8 and 12 years
  • Ability to sit and stand independently
  • Both genders are included (female and male)

You may not qualify if:

  • Having received an injection of botulinum toxin within 3 months
  • Having undergone orthopedic surgery or selective dorsal rhizotomy in the previous 1 year
  • Having undergone HRS training within 6 months;
  • Having severe pain, joint dislocation, contracture, or spinal deformity
  • Having experienced uncontrolled epileptic seizure
  • Having poor visual or hearing acuity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • Jung YG, Chang HJ, Jo ES, Kim DH. The Effect of a Horse-Riding Simulator with Virtual Reality on Gross Motor Function and Body Composition of Children with Cerebral Palsy: Preliminary Study. Sensors (Basel). 2022 Apr 10;22(8):2903. doi: 10.3390/s22082903.

    PMID: 35458888BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Feedback, Sensory

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Study Officials

  • Shehar Bano, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 30, 2024

Study Start

December 1, 2023

Primary Completion

February 5, 2024

Study Completion

February 5, 2024

Last Updated

June 13, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)