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Quality of LifeNCT02460796

Hippotherapy and Parkinson's Disease

An observational study of Quality of Life and Parkinson's Disease, run by University of Brasilia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

BACKGROUND: Motor symptoms associated with Parkinson's disease may impair one's independence and ability to perform daily activities consequently decreases quality of life. Hippotherapy has been shown as an effective treatment to improve function in daily activities and quality of life in other neurological… Read more about this study

Who is it for?
Ages 65 to 83 years
Conditions the study is for
Quality of Life, Parkinson's Disease
What is being tested?
Hippotherapy
How many people
18 participants
Where
No sites listed yet
Study dates
Jun 2013to Oct 2013
How long will I take part?
8 Weeks
Phase
Observational
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 65 to 83 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: 18 volunteers with Parkinson's desease.

Who may be able to join

  • Parkinson's disease patient with H\&Y level 3 at least

Who cannot join

  • Uncontrolled hypertension, unstable cardiovascular disease, chronical disease that can invalidate the research and had practiced riding or hippotherapy six months before the intervention period.

About this study

Official title: Hippotherapy on Functional Capacity and Quality of Life in Parkinson's Disease: a Prospective Study

BACKGROUND: Motor symptoms associated with Parkinson's disease may impair one's independence and ability to perform daily activities consequently decreases quality of life. Hippotherapy has been shown as an effective treatment to improve function in daily activities and quality of life in other neurological populations, thus a study was conducted to assess the effects of hippotherapy in people with Parkinson's disease.

METHODS: Nine volunteers formed the treatment group which participated in a ten-week hippotherapy program, and nine individuals formed the control group (attended a ten-week series of lessons on Parkinson's disease). Outcome measures included 30-second chair stand (as a measure of strength-endurance), gait velocity (during 10m walk test) and health-related quality of life.

Read the detailed description

Parkinson's disease (PD) is associated with motor symptoms such as bradykinesia, rigidity and postural instability 1 which interfere with the patient's independence, and ability to carry out activities of daily life 2. In addition, losses in functional may result in a decreased health-related quality of life (HRQL) 3. Thus, as PD progresses HRQL gets worse 4.

Exercise programs are suggested to improve functional capacity and HRQL in people with PD 3. However, in the later stages of PD, mobility problems restrict the potential to participate in exercise programs, resulting in even greater loss in functional capacity and HRQL. Furthermore, a decline in the efficacy of pharmacological treatment and complications due to motor fluctuations and medication side effects make the role of complementary treatments such as hippotherapy critical to individuals with PD at late stages. Hippotherapy is a therapeutic intervention commonly used in populations with mobility deficits, since they do not require effort or walking from patients who can no exercise in standing position. When is on the horse, the patient exercises as he/she is walking unassisted 5. Neurological conditions are improved by horse's movement stimulations. The set formed by the patient and his horse performs rhythmic and three-dimensional oscillations which trigger very important neuromuscular responses from the rider's postural reflex mechanisms 6. The horse's movements are sensed by the participant on the saddle, and when the horse is slowly walking it has been argued to be similar to the pelvic movement produced by human gait, thereby strengthening the trunk muscles and improving balance 7. The senses are integrated during the act of riding performing sensory stimulation 8. Furthermore, hippotherapy has been demonstrated to be an effective method to improve functional capacity by increasing gait velocity in people with brain disorders 9, functional mobility in elderly 10 and functional strength in people after stroke 11 and in people with spinal cord injury 5. In addition, hippotherapy has been shown to improve HRQL in children and in adults 6.

Considering the potential benefits of hippotherapy to anticipatory postural adjustments and sensory stimulation 9, 11, it could be hypothesized that hippotherapy may increase functional capacity and improve HRQL in individuals with PD. This hypothesis has not been tested yet. Therefore, the purpose of this study was to assess the effects of a hippotherapy program on functional capacity and on HRQL in people with PD.

(4) Methods

Subjects People with confirmed diagnosis of PD by medical report were invited through advertisements on radio, on television, public announcements and posters around the hospitals to participate in the Physical Activities Program for Persons with Neurodegenerative Diseases. Among 81 registered volunteers, 18 participants, six women and twelve men, unable to perform usual physical activity because they were in the late stages according to Hoehn and Yahr scale (H \& Y≥ 3), or because they need to use a wheelchair for severe mobility problems were enrolled in the hippotherapy program which formed the sample (n=18). Exclusion criteria were uncontrolled hypertension, unstable cardiovascular disease and had practiced riding or hippotherapy six months before the intervention period. Among the 18 volunteers from the sample, three women and six men were randomized for the intervention group called hippotherapy group (HT) (n=9), which performed ten weeks of hippotherapy sessions (2 familiarization + 8 hippotherapy weeks) twice a week with each session lasting thirty minutes. Nine other participants who were waiting to be allocated to the hippotherapy program in the following semester attended lectures on PD, twice a week for ten weeks, with each session lasting thirty minutes. Demographics and characteristics of the sample can be seen in Table 1. This study was approved by the Research Ethics Committee of the University of Brasilia on 10/10/2013 by the number CAAE 17329213.7.0000.0030. All participants were informed about the procedures and agreed to participate in the study signing the informed consent term.

Instruments Quality of life was measured using the Parkinson's Disease Quality of Life Questionnaire (PDQL) Brazilian version 4.

Functional mobility was evaluated by the Timed Up and Go Test (TUG) according Podsiadlo and Richardson 12.

Strength endurance was measured using the Thirty-second Chair Stand Test (30CST) according Gill and McBurney 13.

Gait velocity was evaluated using the Ten Meter Walk Test (TMW) according Bohannon, Andrews and Thomas 14.

All functional tests had three trials with a 2 minutes interval between each trial, and the average of the two last measurements was used for analysis.

Hippotherapy Procedures Familiarization sessions were initially 15 minutes and gradually evolved to 30 minutes in order to allow all participants to adapt to the horse's rhythmic movements and to the act of mounting the horse. The sessions were performed at the First Regiment of Cavalry Guard of the Brazilian Army. All practitioners used helmet, shirt, pants and closed shoes. The team was composed by an auxiliary guide, a physical education teacher and two auxiliaries. In order to mount and dismount, all participants used a specific ramp for hippotherapy classes. All horses used saddle and riding equipment, the stirrups were individually adjusted.

The sessions began with a 5 minutes warm up that involved stretching and body awareness exercises. Then, the training was conducted for 20 minutes with arms and torso exercises, changes of direction called serpentine movements; up and down hip movements with feet on stirrups, and forced expiration. In the final 5 minutes, exercises for relaxation were conducted with the horse which involved moving the hand on the horse's neck, laying forward on the head and stroking the horse. The horses walking speed was between 5.8 and 6.4 Km/h.

In order to assess the effect of the hippotherapy the difference between post and pre-tests scores for each dependent measure was calculated (delta (∆)).

To assess whether data had normal distribution the Shapiro-Wilk test was used, which did not indicate a normal distribution for functional capacity variables. Thus, the Mann-Whitney U test for independent samples was used in order to compare the changes in functional capacity between groups. The Shapiro-Wilk test demonstrated a normal distribution for PDQL variables data, and then parametric statistics was performed with a one-way analysis of variance (ANOVA). Statistical analysis was performed using the program Statistica 7.0 (StatSoft Inc., Tulsa, Oklahoma, USA), adopting a significance level of p≤0.05.

Being tested
Hippotherapy
Keywords
Parkinson's disease, Quality of life, Gait velocity, Capacity
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HippotherapyOther

    Also called Equine Therapy

    The sessions began with a 5 minutes warm up that involved stretching and body awareness exercises. Then, the training was conducted for 20 minutes with arms and torso exercises, changes of direction called serpentine movements; up and down hip movements with feet on stirrups, and forced expiration. In the final 5 minutes, exercises for relaxation were conducted with the horse which involved moving the hand on the horse's neck, laying forward on the head and stroking the horse. The horses walking speed was between 5.8 and 6.4 Km/h.

Study groups in NCT02460796
Study groupRoleWhat they receive
hippotherapy group or study group8 weeks of hippotherapy therapy: Familiarization sessions were initially 15 minutes and gradually evolved to 30 minutes in order to allow all participants to adapt to the horse's rhythmic movements and to the act of mounting the horse. Each session had warm up before the training and exercises for relaxation in the end of each session.
Receives: Other: Hippotherapy
control group8 weeks of Parkinson's disease lectures: this group did not hippotherapy classes in the same period.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Increment of gait speed

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2015 (estimated)
  2. Study startJun 2013
  3. Primary completionSep 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
18 participants (actual)
Target duration
8 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT02460796
Sponsor's protocol ID
UnBrasilia
Status last verified
Jun 2015
First submitted
26 May 2015
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23342307
  • 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 24648655
  • de Araujo TB, de Oliveira RJ, Martins WR, de Moura Pereira M, Copetti F, Safons MP. Effects of hippotherapy on mobility, strength and balance in elderly. Arch Gerontol Geriatr. 2013 May-Jun;56(3):478-81. doi: 10.1016/j.archger.2012.12.007. Epub 2013 Jan 3.

    PubMed 23290005
  • Janura M, Peham C, Dvorakova T, Elfmark M. An assessment of the pressure distribution exerted by a rider on the back of a horse during hippotherapy. Hum Mov Sci. 2009 Jun;28(3):387-93. doi: 10.1016/j.humov.2009.04.001. Epub 2009 Apr 29.

    PubMed 19406498
  • Lechner HE, Kakebeeke TH, Hegemann D, Baumberger M. The effect of hippotherapy on spasticity and on mental well-being of persons with spinal cord injury. Arch Phys Med Rehabil. 2007 Oct;88(10):1241-8. doi: 10.1016/j.apmr.2007.07.015.

    PubMed 17908564

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Parkinson's Disease, run by University of Brasilia.

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 1 inclusion and 1 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 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Increment of gait speed (time frame: 4 weeks). 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 NCT02460796, which also lists 5 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 3 Jun 2015.

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Hippotherapy and Parkinson's Disease (NCT02460796) | AzTrials