Effectiveness of Hippotherapy Simulator in Ankylosing Spondylitis

NCT04713813 | Completed

• 1 other identifier: ayk222
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies and meta-analysis showed that different exercise plans had greater benefits than no invention group in improving pain, physical function, and disease activity, especially in some studies that involve ankylosing spondylitis patients receiving home-based exercise. Different kinds of exercises are efficacious and should be recommended to AS patients. But, according to our current knowledge, no clear protocols regarding the effectiveness of hippotherapy in AS patients. This study aims to investigate the effect of the therapeutic horseback riding therapy via a mechanical simulator on disease-specific outcomes and muscle strength of ankylosing spondylitis patients.

Conditions

Ankylosing Spondylitis; Exercise

Keywords

Hippotherapy; occupational therapy; horse; Exercise therapy

Outcome Measures

Primary Outcomes (3)

• Quadriceps muscle strength

  Quadriceps muscle strength will be measured with the microFET®2 Dynamometer.

  At the end of the 12th week of exercise schedule

• Bath Ankylosing Spondylitis Disease Activity Index

  The Bath Ankylosing Spondylitis Disease Activity Index consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS: Spinal pain, Fatigue, Arthralgia, Enthesitis, Morning stiffness severity, Morning stiffness duration. The resulting 0 to 50 score is divided by 5 to give a final 0 - 10 score. Scores of 4 or greater suggest suboptimal control of disease. Higher values indicate more active disease.

  At the end of the 12th week of exercise schedule

• Bath Ankylosing Spondylitis Disease Functional Index

  The ten questions that comprise The Bath Ankylosing Spondylitis Functional Index were chosen with input from patients with Ankylosing spondylitis. The first 8 questions evaluate activities related to functional anatomical limitations due to the course of this inflammatory disease. The final 2 questions evaluate the patients' ability to cope with everyday life. A visual analogue scale (with 0 being "easy" and 10 "impossible) is used to answer the questions on the test. The mean of the ten scales gives the Bath Ankylosing Spondylitis Functional Index score - a value between 0 and 10. A higher score indicates a higher degree of functional limitations.

  At the end of the 12th week of exercise schedule

Study Arms (2)

Exercise group 1(Exercise via mechanical horse-riding simulator)

ACTIVE COMPARATOR

Exercise via mechanical horse-riding simulator; Subjects remained in sitting position for 30 minutes on the simulator during these sessions, with extension of the trunk and stabilization of the pelvis. Feet were placed on the footplates as the simulator produced a rhythmic and repetitive movement similar to a walking horse. The simulator can produce several modes of rhythmic and repetitive motions.

Other: Therapeutic exercise program via hippotherapy mechanical stimulator

Exercise group 2 (Home exercises)

ACTIVE COMPARATOR

Home exercises will be consist of a warm-up, stretching, balance, back walking, fingertip walking exercises, the first of which is shown by the physiatrist or physiotherapist to the patients. These patients will be called twice a month to ask whether they have done the exercises, and the patients whose participation rate is below 80% will be excluded from the study by following the exercise schedule when they come to the physician's control monthly.

Other: Therapeutic home exercise program

Interventions

Therapeutic exercise program via hippotherapy mechanical stimulator OTHER

Patients were planned to complete hippotherapy exercises sessions 3 times a week for 12 weeks, each lasting 35 minutes per sessions.

Exercise group 1(Exercise via mechanical horse-riding simulator)

Therapeutic home exercise program OTHER

Patients were planned to complete home exercises sessions 3 times a week for 12 weeks, each lasting 35 minutes per sessions.

Exercise group 2 (Home exercises)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ankylosing spondylitis diagnosis according to the modified New York criteria
• Voluntary participation in the study
• Age 18-45 years
• Regular use of disease-modifying anti-rheumatic drugs (methotrexate, sulfasalazine, and anti-tumor necrosis factor (TNF) agents) at a stable dosage for at least six weeks.

You may not qualify if:

• Exercising regularly during the previous six months.
• The presence of severe comorbidity that may affect the kidneys, liver, lungs, and heart such as cardiovascular, pulmonary, orthopedic, and neurological problems.
• Problems that may prevent exercise (uncontrollable hypertension, heart attack or history of coronary revascularization, history of syncope or exercise-related arrhythmia, decompensated Type 1 diabetes mellitus, history of hip and/or knee arthroplasty)
• Having undergone any surgery in the previous 6 months
• Any other neuromuscular disease that may affect the muscles' strength.
• Inability to participate in at least 80% of the exercises

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

University of Usak

Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Motor Activity

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Behavior

Study Officials

• Ali Y KARAHAN, MD

  Department of Physical Medicine and Rehabilitation Medical Faculty of Usak University /Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All evaluations for outcomes will perform by the same experienced physiotherapists who will be blind to the study groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, single-blind, controlled clinical trial

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 19, 2021
• Study Start: January 13, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)