NCT04465006

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable stroke

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, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

July 2, 2020

Last Update Submit

July 8, 2020

Conditions

Stroke

Keywords

HippotherapyCerebrovasculer disordersStroke RehabilitationBalanceExercise

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • Rivermead Mobility Index

    The Rivermead Mobility Index assesses functional mobility in gait, balance and transfers after stroke.

    Day 0 - Day 45

  • 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

  • 2 Minute Walk Test

    2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity.

    Day 0 - Day 45

  • 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

Study Arms (2)

Hippotherapy Simulator Group

EXPERIMENTAL

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.

Other: Hippotherapy Simulator

Conventional Exercise Group

EXPERIMENTAL

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.

Other: Conventional Exercise

Interventions

Hippotherapy SimulatorOTHER

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.

Hippotherapy Simulator Group
Conventional ExerciseOTHER

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.

Conventional Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Ersoy Hospital

Sultanbeyli, Istanbul, 34920, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 27708464BACKGROUND

  • 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.

    PMID: 15654030BACKGROUND

  • 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.

    PMID: 27495103BACKGROUND

  • 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.

    PMID: 24396203RESULT

  • 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.

    PMID: 26834368RESULT

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Officials

  • Zubeyir Sarı, Assoc Prof

    Department of Physiotherapy and Rehabilitation - Marmara University

    STUDY CHAIR

  • Sergen Ozturk, PT

    Department of Physiotherapy and Rehabilitation - Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One group received hippotherapy exercise, while the other group received conventional exercise.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 9, 2020

Study Start

December 1, 2018

Primary Completion

April 1, 2019

Study Completion

May 30, 2019

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)