Clinical trial NCT06005909: Current Exercise Approaches in Patients With Multiple Sclerosis
Official title: Investigation of the Effects of Exercises With Mechanical Hippotherapy Device and Cawthorne-Cooksey Exercises on Balance, Dizziness, Fatigue and Quality of Life in Patients With Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Dizziness
Cawthorne-Cooksey
Hippotherapy simulator
Balance
Multiple sclerosis
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The research is a quantitative study, and it is in the form of randomized controlled type research, one of the experimental research types. In order to provide a homogeneous distribution, the patients were divided into two different exercise groups using the double-blind method from the minimization method.

The sample of the study consisted of definitively diagnosed multiple sclerosis (MS) patients who volunteered to participate in the study. Patients who voluntarily agreed to participate in the study; While they were informed about the aims of the study, the duration of the study, the evaluation methods and the applications to be made, the informed consent form was signed by these patients and their consent was obtained. The study sample was divided into two groups by randomization method. The first group was given 35 minutes of traditional physical therapy program and 15 minutes of exercises with a mechanical hippotherapy device, while the second group was given 15 minutes of Cawthorne-Cooksey exercises in addition to the 35-minute traditional physical therapy program. Both exercise groups were given a 50-minute physical therapy program. Patients diagnosed with Multiple Sclerosis in the study; It was classified according to the Expanded Disability Status Scale Score. Tinetti Balance Rating Scale was used to assess balance. The Dizziness Disability Inventory was used to assess dizziness, the Fatigue Severity Scale and the Fatigue Impact Scale to assess fatigue, and the Ferrans \& Powers Quality of Life Index MS Adaptation to assess quality of life.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fatigue severity scale
timeFrame: 10 weeks
measure: Fatigue Impact Scale
timeFrame: 10 weeks
measure: Tinetti balance rating scale
timeFrame: 10 weeks
measure: Dizziness disability inventory
timeFrame: 10 weeks
measure: Ferrans&Powers quality of life index
timeFrame: 10 weeks
measure: Extended disability status scale
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Üsküdar
country: Turkey
facility: Baskent University Istanbul Hospital
state: İstanbul
Study officials:
affiliation: Uskudar University
name: Alesta KABUK
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.