Effectiveness of Hippotherapy Simulator in PwMS

NCT04651725 | Completed

• 1 other identifier: Usak222
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A mechanical horse-riding simulator (MHRS) is a robotic device with a dynamic saddle that mimics the movement of a horse for purpose of hippotherapy. By simulating the rhythmic movements of the horse MHRS aims to increase the patient's balance, flexibility and adaptation and to provide postural adjustment. MHRS is supposed to produce walking patterns of a horse in a three-dimensional aspect. Movements in rhythmic repetitions improve postural coordination, allow to produce a reciprocal pattern. By simulating the rhythmic movements of a horse, MHRS aims to increase the patient's balance, flexibility and adaptation and to provide postural adjustment. This study aims to research the potential benefits of the mechanical horseback riding simulator on the postural balance and symptoms of multiple sclerosis patients.

Conditions

Multiple Sclerosis; Exercise

Keywords

hippotherapy; multiple sclerosis; balance; strength; exercise

Outcome Measures

Primary Outcomes (2)

• Balance dysfunction in Multiple Sclerosis

  The Balance will be measured with the "The Timed Up \& Go (TUG)". TUG provides useful outcomes related to reduced falls risk. In patients with multiple sclerosis the Minimally Detectable Change was 3.5 seconds. Four teen seconds accepted as cut of scores (indicating risk of falls).

  At the end of the 12th week of exercise schedule

• Muscle Strength

  Quadriceps muscle strength will be measured with the microFET2 Dynamometer. The wireless microFET®2 Digital Handheld Dynamometer muscle tester is an accurate, portable Force Evaluation and Testing device. It is a modern adaptation of the time-tested art of hands-on manual muscle testing. Measurement Range 0-300 lbs force.

  At the end of the 12th week of exercise schedule

Secondary Outcomes (1)

• Disability associated with Multiple Sclerosis

  At the end of the 12th week of exercise schedule

Study Arms (2)

Exercise group 1: Exercise via mechanical horse-riding simulator

ACTIVE COMPARATOR

All patients in both groups were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.

Other: Exercises

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: Exercises

Interventions

Exercises OTHER

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

Exercise group 1: Exercise via mechanical horse-riding simulator; Exercise group 2: Home exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent of the patient.
• Minimum age of 18 years
• Confirmed multiple sclerosis diagnosis.
• Expanded Disability Status Scale (EDSS) score below seven

You may not qualify if:

• Any vision or hearing problems,
• The presence of other neurological, orthopedic or rheumatic problems that may limit shoulder-pelvic movement or cause pain,
• Presence of physically disabled or uncontrolled chronic systemic disease,
• Having had a major trauma,
• To receive treatment for shoulder, hip, knee problems in the last 6 months,
• Having had an MS attack in the last 3 months.
• Pregnancy.

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

University of Usak

Uşak, 64200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ali Y Karahan, MD

  University of Usak

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: a blind physiotherapist will assess the study in outcomes in all patients.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of the Department of Rehabilitation Medicine

Model Details: randomized pretest-posttest control group design

Study Record Dates

• First Submitted: November 15, 2020
• First Posted: December 3, 2020
• Study Start: November 1, 2020
• 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)