NCT06005909

Brief Summary

This study was conducted to examine the effects of exercises performed with mechanical hippotherapy device and Cawthorne-Cooksey exercises on balance, dizziness, fatigue and quality of life in patients with Multiple Sclerosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

August 16, 2023

Last Update Submit

August 22, 2023

Conditions

Keywords

DizzinessCawthorne-CookseyHippotherapy simulatorBalanceMultiple sclerosis

Outcome Measures

Primary Outcomes (6)

  • Fatigue severity scale

    The lowest score that can be obtained from the scale is 9, and the highest score is 63. The fatigue severity scale is the average value of nine sections. A high score indicates increased fatigue severity. The scale, including the day it was filled, questions the state of fatigue in the last 1 month.

    10 weeks

  • Fatigue Impact Scale

    The scale consists of 40 questions. The first 10 items evaluate the cognitive state, the second 10 items evaluate the physical state, and the third 20 items evaluate the psychological state. Participants gave each question a score between 0 (no problem) and 4 (maximum problem). The highest score is 160. High scores indicate fatigue. The scales question the state of fatigue in the last 1 month, including the day it was filled in. The fatigue impact scale was found to be the most ideal scale to evaluate the effect of fatigue on daily life in MS.

    10 weeks

  • Tinetti balance rating scale

    The scale includes gait (AS) and balance (EP) subgroups. Evaluation is made with specific scoring criteria for each activity. The total score is a maximum of 28, including the walking subgroup score and the balance subgroup score. The scores obtained by the participants were recorded separately for walking and balance, and the total score was also written. Scores of 18 and below are associated with high, scores between 19 and 23 are associated with moderate, and scores of 24 and above are associated with a low risk of falling.

    10 weeks

  • Dizziness disability inventory

    The participants were asked to score this inventory, which consists of 25 items, according to the frequency and severity of the vertigo complaint and the degree of impact it creates in daily life. Sub-inventories are intended to determine the physical, sensory and functional effects of vestibular system diseases. In the scoring of the sub-units of the inventory, 28 points determine physical disability, 36 points functional and sensory disability. The scores obtained were recorded as physical disability, emotional disability and functional disability data. The final result consists of the sum of all of them. High scores are interpreted as the patient's vertigo complaint preventing his further life.

    10 weeks

  • Ferrans&Powers quality of life index

    This index has 5 subcategories. These; total quality of life score, health and functionality subcategory score, social and economic subcategory score, psychological/belief subcategory score and family subcategory score. The test has two parts, satisfaction and importance, and each part has the same number of questions, question content is the same. The participants were asked to fill in the questionnaire and the physiotherapist calculated the values in accordance with the scoring instructions. The score of these collected values was divided by the number of marked questions. The final score was obtained by adding 15 to the obtained values. The final score is between 0-30.

    10 weeks

  • Extended disability status scale

    In the Disability Status Scale, the patient is evaluated over a total of 10 points. While zero indicates normal health status, 10 indicates death due to an uncommon Multiple Sclerosis. In this scale, which consists of twenty steps, 0 indicates normal neurological finding; 10 means death due to MS. Scores on the Extended disability status scale increase to correspond with worsening in MS. The first score after 0 is 1, and then clinical worsening is expressed in 0.5-point intervals.

    10 weeks

Study Arms (2)

Cawthorne-Cooksey

EXPERIMENTAL

These exercises, which are designed to reduce vertigo, stabilize the gaze and improve balance by stimulating or operating the vestibular system during daily activities, consist of a series of eye, head, trunk and balance movements that provoke vestibular symptoms and whose difficulty increases. The degree of difficulty of the exercises was increased with the improvement of the patient. Head and trunk movements while sitting, standing and walking were added to the exercises that initially started with simple eye-head movements in bed.

Other: Cawthorne-Cooksey Exercises

Mechanical Hippotherapy

EXPERIMENTAL

Before being taken to the device, the patients were informed about the working principle of the device, the exercises to be performed on the device, and that the exercise would be terminated in case of a possible health problem. After being placed on the device, the patient was given time until the initial balance was achieved. When the patient felt ready, a 15-minute hippotherapy session was applied at the 5th level of the 20-stage speed level by the physiotherapist.

Other: Mechanical Hippotherapy Exercises

Interventions

A- Head and Eye Movements While Lying and Sitting: 1. While keeping your head still, look up and then down again. 2. Look from side to side while keeping your head still. 3. Extend your hand at arm's length, draw your fingers towards your nose while focusing your eyes on your fingers. 4. With eyes open, slowly turn your head from side to side. 5. Turn your head from side to side quickly. 6. With eyes open, slowly move your head up and down. 7. Move your head up and down quickly. 8. Repeat items 4,5,6 and 7 with your eyes closed. B-Head and Body Movements While Sitting: 1. Place an object on the floor in front of your feet, reach out to pick it up, then upright return to your position. Looking down while picking up the item, then Remind you to look up when trying to fix it. 2. Lean forward and move the object forward and back under your knees. C- Standing Exercises 1-Get from a sitting position to a standing position and sit down again. 2-Repeat this with your eyes closed.

Cawthorne-Cooksey

From the patient on the mechanical hippotherapy device; * Maintaining trunk balance while raising both hands above head, * Maintaining trunk balance while opening the arms next to the trunk, * Maintaining trunk balance while extending the arms back and forth with successive movements, * Maintaining trunk balance with hands clasped behind the waist, * The arms are open to both sides, while transferring the weight ball from one hand to the other, it is requested to maintain the body balance.

Mechanical Hippotherapy

Eligibility Criteria

Age25 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being cooperative and oriented,
  • Being 25 - 64 years
  • Having a definite diagnosis of MS,
  • Being able to sit dependent/independently and stand supported/unsupported,
  • Not having an attack in the last 1 month or not currently in the attack period,
  • Volunteering to participate in the study.

You may not qualify if:

  • Having another neurological disease or musculoskeletal system problems in addition to the diagnosis of MS,
  • Being on cortisone treatment in the last 1 month or still ongoing,
  • Having a mental, cardiovascular, pulmonary or orthopedic disease that will prevent exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Istanbul Hospital

Üsküdar, Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Coban 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.

    PMID: 37303153BACKGROUND
  • Tacalan E, Inal HS, Senturk MN, Mengi E, Alemdaroglu-Gurbuz I. Effectiveness of the Epley maneuver versus Cawthorne-Cooksey vestibular exercises in the treatment of posterior semicircular canal benign paroxysmal positional vertigo (BPPV): A randomized controlled trial. J Bodyw Mov Ther. 2021 Oct;28:397-405. doi: 10.1016/j.jbmt.2021.07.030. Epub 2021 Aug 8.

    PMID: 34776169BACKGROUND
  • Afrasiabifar A, Karami F, Najafi Doulatabad S. Comparing the effect of Cawthorne-Cooksey and Frenkel exercises on balance in patients with multiple sclerosis: a randomized controlled trial. Clin Rehabil. 2018 Jan;32(1):57-65. doi: 10.1177/0269215517714592. Epub 2017 Jun 19.

    PMID: 28629268BACKGROUND

MeSH Terms

Conditions

Multiple SclerosisDizziness

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alesta KABUK

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 23, 2023

Study Start

February 1, 2022

Primary Completion

May 1, 2022

Study Completion

April 30, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations