Clinical trial NCT03528993: The Effect of Exercise by Mechanical Hippotherapy Device on Postural Stability and Balance in Stroke
Official title: The Effect of Exercise by Mechanical Hippotherapy Device on Postural Stability and Balance in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait, Hemiplegic
Balance, Postural
Keywords: stroke, hippotherapy, balance, postural control, gait
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

Detailed description: Investigator will randomly allocate 30 patients with hemiplegia to two groups; Control group (n=15), experimental group(n=15).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, while 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. Assessment procedure will be held at the beginning and 4th week of study. Assessment procedure will be held at the beginning and 4th week of study. All subjects will be assessed by berg balance scale and BIODEX primarily while Timed up and go test, SF-36, Functional reach test, functional independence measurement(FIM), Trunk Impairment Scale (TIS), Trunk Control Test (TCT), motricity index, Fugl-meyer will be held secondarily.

Eligibility criteria: Inclusion Criteria:

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

Exclusion criteria:

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

Primary outcomes:
measure: Berg balance scale
timeFrame: Change from baseline to week 4
measure: BIODEX balance systems
timeFrame: Change from baseline to week 4
Secondary outcomes:
measure: Timed Up and Go Test
timeFrame: Change from baseline to week 4
measure: SF-36 (The Short Form Health Survey)
timeFrame: Change from baseline to week 4
measure: Functional Reach Test
timeFrame: Change from baseline to week 4
measure: Functional Independence Measurement(FIM)
timeFrame: Change from baseline to week 4
measure: Fugl-Meyer Assessment of Motor Recovery after Stroke
timeFrame: Change from baseline to week 4
measure: The Trunk Control Test (TCT)
timeFrame: Change from baseline to week 4
measure: Trunk Impairment Scale (TIS)
timeFrame: Change from baseline to week 4
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: fatma mutluay
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.