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Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hippotherapy Simulator
Conventional Exercise
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Hippotherapy, Cerebrovasculer disorders, Stroke Rehabilitation, Balance, Exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Private Ersoy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hippotherapy Simulator Group

Conventional Exercise Group

Arm Description

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 walking aid, To be able to understand and follow audio and visual warnings, Scoring 24 points or more from the Mini Mental State Exam.

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 walking aid, To be able to understand and follow audio and visual warnings, Scoring 24 points or more from the Mini Mental State Exam.

Outcomes

Primary Outcome Measures

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.
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
Rivermead Mobility Index
The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers after stroke.
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.
2 Minute Walk Test
2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity.
Barthel Index
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).

Secondary Outcome Measures

Full Information

First Posted
July 2, 2020
Last Updated
July 8, 2020
Sponsor
Marmara University
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1. Study Identification

Unique Protocol Identification Number
NCT04465006
Brief Title
Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients
Official Title
Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Hippotherapy, Cerebrovasculer disorders, Stroke Rehabilitation, Balance, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group received hippotherapy exercise, while the other group received conventional exercise.
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hippotherapy Simulator Group
Arm Type
Experimental
Arm Description
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 walking aid, To be able to understand and follow audio and visual warnings, Scoring 24 points or more from the Mini Mental State Exam.
Arm Title
Conventional Exercise Group
Arm Type
Experimental
Arm Description
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 walking aid, To be able to understand and follow audio and visual warnings, Scoring 24 points or more from the Mini Mental State Exam.
Intervention Type
Other
Intervention Name(s)
Hippotherapy Simulator
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
Day 0 - Day 45
Title
Postural Assessment Scale for Stroke
Description
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
Time Frame
Day 0 - Day 45
Title
Rivermead Mobility Index
Description
The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers after stroke.
Time Frame
Day 0 - Day 45
Title
Timed Up and Go Test
Description
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.
Time Frame
Day 0 - Day 45
Title
2 Minute Walk Test
Description
2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity.
Time Frame
Day 0 - Day 45
Title
Barthel Index
Description
The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).
Time Frame
Day 0 - Day 45

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubeyir Sarı, Assoc Prof
Organizational Affiliation
Department of Physiotherapy and Rehabilitation - Marmara University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sergen Ozturk, PT
Organizational Affiliation
Department of Physiotherapy and Rehabilitation - Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Ersoy Hospital
City
Sultanbeyli
State/Province
Istanbul
ZIP/Postal Code
34920
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27708464
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. doi: 10.2471/BLT.16.181636. No abstract available.
Results Reference
background
PubMed Identifier
15654030
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. doi: 10.1136/jnnp.2004.040543.
Results Reference
background
PubMed Identifier
27495103
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.
Results Reference
background
PubMed Identifier
24396203
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.
Results Reference
result
PubMed Identifier
26834368
Citation
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.
Results Reference
result

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Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients

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