StrokeNCT03528993
The Effect of Exercise by Mechanical Hippotherapy Device on Postural Stability and Balance in Stroke
A study testing exercise by hippotherapy device and conventional rehabilitation in people with Stroke and Gait, Hemiplegic, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Gait, Hemiplegic, Balance, Postural
- What is being tested?
- exercise by hippotherapy device and conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mini Mental Test score more than 24
- Ability to stand and sit independently
- Ability to follow and understand verbal instructions.
Who cannot join
- Musculoskeletal problems
- Neurologic deficits such as unilateral neglect, hemianopsia, and apraxia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Gait, Hemiplegic, Balance, Postural
- Being tested
- exercise by hippotherapy device, conventional rehabilitation, postural control exercises
- Keywords
- stroke, hippotherapy, balance, postural control, gait
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise by hippotherapy deviceOther
Hippotherapy device mostly used on cerebral palsy, but we want to use hippotherapy device on patient with Hemiplegia.
conventional rehabilitationOther
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).
postural control exercisesOther
perturbation on four directions, weight bearing exercises on standing positions
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: conventional rehabilitation; Other: postural control exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: Change from baseline to week 4
Secondary outcomes (7)
Timed Up and Go Test
This test was initially designed for elderly persons To determine fall risk and measure the progress of balance, sit to stand, and walking, is used for people with stroke, Parkinsons, Multiple Sclerosis, hip fracture, Alzheimer, Huntington Disease and others.
Measured: Change from baseline to week 4
SF-36 (The Short Form Health Survey)
The Short Form-36 (SF-36) is a 36 item questionnaire which measures Quality of Life (QoL) across eight domains, which are both physically and emotionally based. The eight domains that the SF36 measures are as follows: physical functioning; role limitations due to physical health; role limitations due to emotional problems; energy/fatigue; emotional well-being; social functioning; pain; general health. A single item is also included that identifies perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment.
Measured: Change from baseline to week 4
Functional Reach Test
The Functional Reach Test was first developed by Pamela Duncan and colleagues in 1990. It is a quick and simple, single-task dynamic test that defines functional reach as "the maximal distance one can reach forward beyond arm's length, while maintaining a fixed base of support in the standing position". It is a dynamic rather than a static test and measures a person's "margin of stability" as well as ability to maintain balance during a functional task. The test has been shown by Duncan to be predictive of falls in older adults.
Measured: Change from baseline to week 4
Functional Independence Measurement(FIM)
The Functional Independence Measure (FIM) is an 18-item of physical, psychological and social function. The tool is used to assess a patient's level of disability as well as change in patient status in response to rehabilitation or medical intervention. Tasks that are evaluated using the FIM include bowel and bladder control, transfers, locomotion, communication, social cognition as well as the following six self-care activities: Feeding,Grooming, Bathing, Upper Body Dressing, Lower Body Dressing,Toileting
Measured: Change from baseline to week 4
Fugl-Meyer Assessment of Motor Recovery after Stroke
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities), Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints), Balance (contains 7 tests, 3 seated and 4 standing), Joint range of motion (8 joints), Joint pain.
Measured: Change from baseline to week 4
The Trunk Control Test (TCT)
The Trunk Control Test can be used to assess the motor impairment in a patient who has had a stroke. It correlates with eventual walking ability. It has 4 items: 1) Rolling to weak side 2) Rolling to strong side 3) Balance in sitting position 4) Sit up from lying down. Total score range: 0 (minimum) to 100 (maximum, indicating better performance). Score of each item: (0, 12 or 25). 0 = unable to perform movement without assistance. 12 = able to perform movement, but in an abnormal style 25 = able to complete movement normally. For the sitting balance item, a patient scores 12 if they need to touch anything with their hands to stay upright, and 0 if they are unable to stay up (by any means) for 30 seconds.
Measured: Change from baseline to week 4
Trunk Impairment Scale (TIS)
Trunk Impairment Scale (TIS) measures the motor impairment of the trunk after a stroke through the evaluation of static and dynamic sitting balance as well as co-ordination of trunk movement. The static subscale investigates: (1) the ability of the subject to maintain a sitting position; (2) the ability to maintain a sitting position while the legs are passively crossed, (3) the ability to maintain a sitting position when the subject crosses the legs actively. The dynamic subscale contains items on L. flexion of the trunk and unilateral lifting of the hip. To assess the coordination of the trunk, the subject is asked to rotate the upper or lower part of his or her trunk 6 times, Scores range from a minimum of 0 to a maximum of 23. If patient scores 0 on the first item, the total score on the TIS is 0.
Measured: Change from baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Apr 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, osman coban, Istanbul Medipol University Hospital
- Investigators
- fatma mutluay, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528993
- Sponsor's protocol ID
- 2018-02
- Status last verified
- Aug 2019
- First submitted
- 23 Apr 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24648655Han 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.
PubMed 23342307Sung 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.
PubMed 23949070Coban 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.
PubMed 37303153
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise by Mechanical Hippotherapy Device on Postural Stability and Balance in Stroke
- ClinicalTrials.gov ID
- NCT03528993
- Acronym / sponsor ID
- 2018-02
- Conditions
- Stroke, Gait, Hemiplegic, Balance, Postural
- Keywords
- stroke, hippotherapy, balance, postural control, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise by hippotherapy device group | Experimental | Other: exercise by hippotherapy device, Other: conventional rehabilitationThe 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 |
| Control group | Other | Other: conventional rehabilitation, Other: postural control exercisesThe control group will receive conventional rehabilitation for 45 min/day, following by postural control exercises 15 min/day 5 times/week for 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mini Mental Test score more than 24
- Ability to stand and sit independently
- Ability to follow and understand verbal instructions.
Key exclusion criteria (2 listed)
- Musculoskeletal problems
- Neurologic deficits such as unilateral neglect, hemianopsia, and apraxia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise by hippotherapy deviceHippotherapy device mostly used on cerebral palsy, but we want to use hippotherapy device on patient with Hemiplegia. | Other | Exercise by hippotherapy device group |
| conventional rehabilitationBobath 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). | Other | Control group, Exercise by hippotherapy device group |
| postural control exercisesperturbation on four directions, weight bearing exercises on standing positions | Other | Control group |
Primary outcome
Berg balance scale
Time frame: Change from baseline to week 4
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
BIODEX balance systems
Time frame: Change from baseline to week 4
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).
7 secondary outcomes
Timed Up and Go Test
Time frame: Change from baseline to week 4
SF-36 (The Short Form Health Survey)
Time frame: Change from baseline to week 4
Functional Reach Test
Time frame: Change from baseline to week 4
Functional Independence Measurement(FIM)
Time frame: Change from baseline to week 4
Fugl-Meyer Assessment of Motor Recovery after Stroke
Time frame: Change from baseline to week 4
The Trunk Control Test (TCT)
Time frame: Change from baseline to week 4
Trunk Impairment Scale (TIS)
Time frame: Change from baseline to week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 24648655Lee 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.
- Background: PubMed 23342307Han 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.
- Background: PubMed 23949070Sung 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.
- Derived from this study: PubMed 37303153Coban 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fatma mutluay study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise by hippotherapy device and conventional rehabilitation in people with Stroke and Gait, Hemiplegic, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg balance scale (time frame: Change from baseline to week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528993, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.