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Completed

NCT Number: NCT04465006

Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Ersoy Hospital

Sultanbeyli, Istanbul, 34920, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hippotherapy Simulator

Other

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

Other

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 outcomes

  1. Berg Balance Scale

    Time frame: Day 0 - Day 45

    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.

  2. Postural Assessment Scale for Stroke

    Time frame: Day 0 - Day 45

    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

  3. Rivermead Mobility Index

    Time frame: Day 0 - Day 45

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

  4. Timed Up and Go Test

    Time frame: Day 0 - Day 45

    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.

  5. 2 Minute Walk Test

    Time frame: Day 0 - Day 45

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

  6. Barthel Index

    Time frame: Day 0 - Day 45

    The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL).

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 9, 2020
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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