Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT03528993
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Exercise by Mechanical Hippotherapy Device on Postural Stability and Balance in Stroke
Sponsor:
Istanbul Medipol University Hospital
Organization:
Study Overview
Official Title:
The Effect of Exercise by Mechanical Hippotherapy Device on Postural Stability and Balance in Stroke
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: