Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients

Stroke Clinical Trial

Official title:

Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465006
• Other study ID #: 09.2018.425
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: July 2020
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to investigate the effects of hippotherapy simulator exercises in addition to the conventional rehabilitation program on the balance, postural control, mobility, functional capacity, and independence levels of stroke patients.

Description:

Twenty-six 18- 65 years of patients with stroke were included in the study. Patients were divided into two groups as hippotherapy simulator group (HSG) (n = 13) and conventional exercise group (CEG) (n = 13). Patients were evaluated with Berg Balance Scale (BBS) for balance, Postural Assessment Scale for Stroke (PASS) for postural control, Rivermead Mobility Index (RMI), and Time Up- Go Test (TUG) for mobility, 2min. Walking Test (2mWT) for functional capacity and Barthel Index (BI) for the level of independence respectively before and after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 30, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Getting a diagnosis of stroke by a specialist physician,

• Being between the ages of 18-65,

• Having a stroke history of 3- 36 months,

• To be able to sit without support while both soles are in contact with the floor,

• To be able to walk independently with or without using a walking aid,

• To be able to understand and follow audio and visual warnings,

• Scoring 24 points or more from the Mini-Mental State Exam.

Exclusion Criteria:

• Multiple stroke stories,

• Hemorrhagic type stroke history,

• Those with a history of falling in the past 1 year,

• Those with a history of epilepsy,

• Uncontrolled history of Hypertension and Diabetes

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Hippotherapy Simulator
Patients in the hippotherapy simulator group received 30 sessions of treatment for 6 weeks, 5 days a week and 1 hour a day. 45 minutes of Neurodevelopmental treatment exercises and 15 minutes of hippotherapy simulation exercise program were applied to the participants in this group.
• Conventional Exercise
Patients in the conventionnal exercise group received 30 sessions of treatment for 6 weeks, 5 days a week and 1 hour a day. 60 minutes of Neurodevelopmental treatment exercises were applied to the participants in this group.

Locations

Country	Name	City	State
Turkey	Private Ersoy Hospital	Sultanbeyli	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Ciou SH, Hwang YS, Chen CC, Chen SC, Chou SW, Chen YL. Balance training using an interactive game to enhance the use of the affected side after stroke. J Phys Ther Sci. 2015 Dec;27(12):3855-61. doi: 10.1589/jpts.27.3855. Epub 2015 Dec 28. — View Citation

Huang CY, Lin GH, Huang YJ, Song CY, Lee YC, How MJ, Chen YM, Hsueh IP, Chen MH, Hsieh CL. Improving the utility of the Brunnstrom recovery stages in patients with stroke: Validation and quantification. Medicine (Baltimore). 2016 Aug;95(31):e4508. doi: 10.1097/MD.0000000000004508. — View Citation

Johnson W, Onuma O, Owolabi M, Sachdev S. Stroke: a global response is needed. Bull World Health Organ. 2016 Sep 1;94(9):634-634A. — View Citation

Kim S, Yuk GC, Gak H. Effects of the horse riding simulator and ball exercises on balance of the elderly. J Phys Ther Sci. 2013 Nov;25(11):1425-8. doi: 10.1589/jpts.25.1425. Epub 2013 Dec 11. — View Citation

Nedeltchev K, der Maur TA, Georgiadis D, Arnold M, Caso V, Mattle HP, Schroth G, Remonda L, Sturzenegger M, Fischer U, Baumgartner RW. Ischaemic stroke in young adults: predictors of outcome and recurrence. J Neurol Neurosurg Psychiatry. 2005 Feb;76(2):191-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale	The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.	Day 0 - Day 45
Primary	Postural Assessment Scale for Stroke	It measures the ability of an individual with stroke to maintain stable postures and equilibrium during positional changes. It consists of a 4-point scale where the items are scored from 0 to 3, and the total scoring ranges from 0 to 36	Day 0 - Day 45
Primary	Rivermead Mobility Index	The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers after stroke.	Day 0 - Day 45
Primary	Timed Up and Go Test	The Timed Up and Go (TUG) test is a performance-based measure of functional mobility that was initially developed to identify mobility and balance impairments in older adults.	Day 0 - Day 45
Primary	2 Minute Walk Test	2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity.	Day 0 - Day 45
Primary	Barthel Index	The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).	Day 0 - Day 45