Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT04465006
Collaborator
(none)
26
1
2
5.9
4.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hippotherapy Simulator
  • Other: Conventional Exercise
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
One group received hippotherapy exercise, while the other group received conventional exercise.One group received hippotherapy exercise, while the other group received conventional exercise.
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Efficacy of Hippotherapy Simulator Exercise Program in Stroke Patients
Actual Study Start Date :
Dec 1, 2018
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
May 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hippotherapy Simulator Group

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
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.

Experimental: Conventional Exercise Group

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
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.

Outcome Measures

Primary Outcome Measures

  1. Berg Balance Scale [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 [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 [Day 0 - Day 45]

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

  4. Timed Up and Go Test [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 [Day 0 - Day 45]

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

  6. Barthel Index [Day 0 - Day 45]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private Ersoy Hospital Sultanbeyli Istanbul Turkey 34920

Sponsors and Collaborators

  • Marmara University

Investigators

  • Study Chair: Zubeyir Sarı, Assoc Prof, Department of Physiotherapy and Rehabilitation - Marmara University
  • Principal Investigator: Sergen Ozturk, PT, Department of Physiotherapy and Rehabilitation - Marmara University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Marmara University
ClinicalTrials.gov Identifier:
NCT04465006
Other Study ID Numbers:
  • 09.2018.425
First Posted:
Jul 9, 2020
Last Update Posted:
Jul 9, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marmara University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 9, 2020