Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy

NCT03870893 | Completed Results

• 1 other identifier: 2017-0665-000
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This research analyzes whether hippotherapy improves the physical activity, cardiopulmonary fitness, and attention in children with cerebral palsy and whether this enhances their general health and quality of life.

Conditions

Cerebral Palsy; Physical Activity; Attention Disorder

Keywords

cerebral palsy; hippotherapy; cardiopulmonary fitness; physical activity; attention

Outcome Measures

Primary Outcomes (1)

• Change of Clinical Global Improvement(CGI)

  The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Lower values represent a better outcome. The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as 1= very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Higher values represent a better outcome.

  Change in baseline CGI at 16weeks

Secondary Outcomes (18)

• Change of Attention

  Change in baseline attention at 16weeks

• Change of Physical Activity(%)

  Change in baseline physical activity at 16weeks

• Change of Peak Oxygen Uptake(VO2peak)

  Change in baseline peak oxygen uptake at 16weeks

• Change of Gross Motor Function Measure 66

  Change in baseline Gross Motor Function Measure 66 at 16weeks

• Change of Physical Activity(Steps)

  Change in baseline steps at 16weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Intervention is administered to patients in this Arm.

Behavioral: hippotherapy

control group

NO INTERVENTION

No intervention

Interventions

hippotherapy BEHAVIORAL

16weeks hippotherapy program

Intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of spastic CP
• GMFCS level I-III
• weight \< 35kg
• ability to walk independently with or without an assistive device
• ability to comply with the study protocol and follow verbal directions

You may not qualify if:

• botulinum toxin injection within 3 months
• orthopedic surgery within 1 year (difficulty performing one step instructions)
• moderate to severe intellectual disability
• uncontrolled seizure
• poor visual or hearing acuity
• patients who weigh more than 35 kg
• hip dislocation
• scoliosis more than 30 degrees
• musculoskeletal surgery within 1 year

Sponsors & Collaborators

• Samsung Medical Center: lead
• National Research Foundation of Korea: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (3)

• Suk MH, Kwon JY. Effect of Equine-Assisted Activities and Therapies on Cardiorespiratory Fitness in Children with Cerebral Palsy: A Randomized Controlled Trial. J Integr Complement Med. 2022 Jan;28(1):51-59. doi: 10.1089/jicm.2021.0158.

  PMID: 35085017 DERIVED

• Ahn B, Joung YS, Kwon JY, Lee DI, Oh S, Kim BU, Cha JY, Kim JH, Lee JY, Shin HY, Seo YS. Effects of equine-assisted activities on attention and quality of life in children with cerebral palsy in a randomized trial: examining the comorbidity with attention-deficit/hyperactivity disorder. BMC Pediatr. 2021 Mar 19;21(1):135. doi: 10.1186/s12887-021-02597-0.

  PMID: 33740922 DERIVED

• Park IK, Lee JY, Suk MH, Yoo S, Seo YG, Oh JK, Kwon JY. Effect of Equine-Assisted Activities on Cardiac Autonomic Function in Children with Cerebral Palsy: A Pilot Randomized-Controlled Trial. J Altern Complement Med. 2021 Jan;27(1):96-102. doi: 10.1089/acm.2020.0346. Epub 2020 Nov 27.

  PMID: 33252241 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity; Cognition Disorders

Interventions

Equine-Assisted Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Animal Assisted Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Jeong-Yi Kwon
• Organization: Samsung Medical Center

jeongyi.kwon@samsung.com

+821045911039

Study Officials

• Minhwa Suk

  Researcher

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: March 12, 2019
• Study Start: July 5, 2017
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: August 5, 2020
• Results First Posted: August 5, 2020

Record last verified: 2020-07

Locations

KR (1)