The Effect of Exercise by Mechanical Hippotherapy Device on Postural Stability and Balance in Stroke

NCT03528993 | Completed DMC

• 1 other identifier: 2018-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke,one of the leading cause of death, is caused by ischemia or hemorrhage. It results in neurological deficits such as hemiplegia. Hemiplegia show disability characterized loss of motor, sensory and cognitive function. Reduced postural control and balance stability results gait disturbances such as asymmetric weight bearing, risk of falling and imbalances. It also shows increased energy expenditure, decreased independence on quality of life and limited mobility. Physical therapy can be effective method for solving these problems. Hippotherapy, also known as horseback riding therapy, is a form of physical therapy strategy that uses equine movement. The concept of hippotherapy is to use a horse as a therapeutic tool, and it is based on similarities in gait between the human and horse. The horse's gait provides patients having motor disabilities with rhythmic and repetitive movements similar to human walking, thereby giving them training opportunities to improve posture, balance, and strength. Even though it has many effect on solving these problems, hippotherapy centers are not enough. Due to climate and environmental situations, hippotherapy devices were improved and had similar effects on patients with stroke. In literature, these device mostly used on cerebral palsy, but investigator wants to use hippotherapy device on patient with Hemiplegia. For these reasons, the effects of exercises by mechanical hippotherapy device on postural control and balance will be investigated.

Conditions

Stroke; Gait, Hemiplegic; Balance, Postural

Keywords

stroke, hippotherapy, balance, postural control, gait

Outcome Measures

Primary Outcomes (2)

• Berg balance scale

  The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks. It is a valid instrument used for evaluation of the effectiveness of interventions and for quantitative descriptions of function in clinical practice and research. The BBS has been evaluated in several reliability studies. A recent study of the BBS, which was completed in Finland, indicates that a change of eight (8) BBS points is required to reveal a genuine change in function between two assessments among older people who are dependent in ADL and living in residential care facilities. 14-item scale designed to measure balance of the older adult in a clinical setting. Equipment needed: Ruler, two standard chairs (one with arm rests, one without), footstool or step, stopwatch or wristwatch, 15 ft walkway Completion Time: 15-20 minutes

  Change from baseline to week 4

• BIODEX balance systems

  Biodex Balance System (BBS), a commercially available balance device, Biodex Medical Systems, Shirley, NY, USA) will used to assess fall risk and balance. It consists of a movable balance platform which provides up to 20° of surface tilt in a 360° range of motion and the platform is interfaced with computer software (Upper display module-firmware version 1.09, Lower control board-firmware version 1.03, Biodex Medical Systems) that enables the device to serve as an objective assessment of balance and fall risk. The system had various difficulty levels which range from 1 (most difficult) to 12 (the easiest). two settings will be used to assess the dynamic balance and the fall risk;the postural stability test (PST) and the fall risk test (FRT).

  Change from baseline to week 4

Secondary Outcomes (7)

• Timed Up and Go Test

  Change from baseline to week 4

• SF-36 (The Short Form Health Survey)

  Change from baseline to week 4

• Functional Reach Test

  Change from baseline to week 4

• Functional Independence Measurement(FIM)

  Change from baseline to week 4

• Fugl-Meyer Assessment of Motor Recovery after Stroke

  Change from baseline to week 4

Study Arms (2)

Exercise by hippotherapy device group

EXPERIMENTAL

The experimental group receive conventional rehabilitation for 45 min/day following by use of a hippotherapy device for 15 min/day, 5 times/week for 4 weeks

Other: exercise by hippotherapy device; Other: conventional rehabilitation

Control group

OTHER

The control group will receive conventional rehabilitation for 45 min/day, following by postural control exercises 15 min/day 5 times/week for 4 weeks.

Other: conventional rehabilitation; Other: postural control exercises

Interventions

exercise by hippotherapy device OTHER

Hippotherapy device mostly used on cerebral palsy, but we want to use hippotherapy device on patient with Hemiplegia.

Exercise by hippotherapy device group

conventional rehabilitation OTHER

Bobath exercises: Bobath is a type of physiotherapy treatment which aims to improve movement and mobility in patients with damage to their central nervous system (brain and spinal cord).

Control group; Exercise by hippotherapy device group

postural control exercises OTHER

perturbation on four directions, weight bearing exercises on standing positions

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mini Mental Test score more than 24
• Ability to stand and sit independently
• Ability to follow and understand verbal instructions.

You may not qualify if:

• Musculoskeletal problems
• Neurologic deficits such as unilateral neglect, hemianopsia, and apraxia

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

• Lee CW, Kim SG, Yong MS. Effects of hippotherapy on recovery of gait and balance ability in patients with stroke. J Phys Ther Sci. 2014 Feb;26(2):309-11. doi: 10.1589/jpts.26.309. Epub 2014 Feb 28.

  PMID: 24648655 BACKGROUND

• Han JY, Kim JM, Kim SK, Chung JS, Lee HC, Lim JK, Lee J, Park KY. Therapeutic effects of mechanical horseback riding on gait and balance ability in stroke patients. Ann Rehabil Med. 2012 Dec;36(6):762-9. doi: 10.5535/arm.2012.36.6.762. Epub 2012 Dec 28.

  PMID: 23342307 BACKGROUND

• Sung YH, Kim CJ, Yu BK, Kim KM. A hippotherapy simulator is effective to shift weight bearing toward the affected side during gait in patients with stroke. NeuroRehabilitation. 2013;33(3):407-12. doi: 10.3233/NRE-130971.

  PMID: 23949070 BACKGROUND

• Coban O, Mutluay F. The effects of mechanical hippotherapy riding on postural control, balance, and quality of life (QoL) in patients with stroke. Disabil Rehabil. 2024 Jun;46(11):2338-2347. doi: 10.1080/09638288.2023.2221458. Epub 2023 Jun 11.

  PMID: 37303153 DERIVED

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• fatma mutluay

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, MSc

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 18, 2018
• Study Start: April 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: May 30, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

TU (1)