Effect of Hydrotherapy on Multiple Sclerosis

Sponsor

University of Thessaly (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06121648

Collaborator

(none)

Enrollment

Location

Arms

3.4

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this work was to investigate the effect of a hydrotherapy program on the balance and fatigue of patients with multiple sclerosis. it is a fact that hydrotherapy has an effect on the rehabilitation and treatment of people with balance problems.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: hydrotherapy Other: neurological physiotherapy	N/A

Detailed Description

26 patients with multiple sclerosis participated in the present research, who were divided into 2 intervention groups, one in the sea and one on land. The intervention program had a duration of 2 months with a frequency of 2 times a week for both groups. The interventions were performed by specialized therapists. All participants were assessed before and after the intervention using the BBS and MFIS scales.

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 groups water group land group2 groups water group land group

Masking:

Single (Participant)

Masking Description:

closed envelopes

Primary Purpose:

Treatment

Official Title:

Effect of Hydrotherapy on the Balance and Fatigue of Multiple Sclerosis Patients

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Nov 2, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Water Group Static and dynamic balance, breathing, combined breathing and movement activities.	Other: hydrotherapy 30 degrees temperature pool balance and breathing therapy
Active Comparator: Land Group Intervention program focused on balance and gait.	Other: neurological physiotherapy Balance and neurological physiotherapy on land

Arm

Intervention/Treatment

Experimental: Water Group

Static and dynamic balance, breathing, combined breathing and movement activities.

Other: hydrotherapy

30 degrees temperature pool balance and breathing therapy

Active Comparator: Land Group

Intervention program focused on balance and gait.

Other: neurological physiotherapy

Balance and neurological physiotherapy on land

Outcome Measures

Primary Outcome Measures

BBS scale [2 months]
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
MFIS scale [2 months]
The total MFIS score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales.

Eligibility Criteria

Criteria

Ages Eligible for Study:

23 Years to 42 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnosed with RR-type (relapsing-remitting) multiple sclerosis by MS ( multiple sclerosis) expert neurologists, and Expanded Disability Status Scale (EDSS) cit 10 Score of 1-3.7 participated in this study.

Exclusion Criteria:

older than 45 years; EDSS Score>3,7; primary progressive MS; acute or chronic physical or psychological disorders; participation in less than 12 of the 16 hydrotherapy sessions; common contraindications for hydrotherapy as cardiovascular disease, allergy etc.,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Thessaly	Lamía	Central Macedonia	Greece	35100

Sponsors and Collaborators

University of Thessaly

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

1.Beck CA, Metz LM, Svenson LW, Patten SB. Regional variation of multiple sclerosis prevalence in Canada. Mult Scler 2005;11(5):516-9. 2.Corvillo I, Varela E, Armijo F, Alvarez-Badillo A, Armijo O, Maraver F. Efficacy of aquatic therapy for multiple sclerosis: a systematic review. Eur J Phys Rehabil Med 2017 [ahead of print]. 3.Multiple sclerosis: Hope through research. https://www.ninds.nih.gov/ Disorders/Patient-Caregiver-Education/Hope-Through-Research/MultipleSclerosis-Hope-Through-Research. Accessed October 1, 2018. 4. Ms prevalence: National multiple sclerosis society. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 2, 2018, 2018. 10 Kurtzke JF. Rating neurologic impairment in multiple sclerosis. Neurology 1983;33:1444. Alikhajeh, Y., Hosseini, S. R. A., & Moghaddam, A. (2012). Effects of hydrotherapy in static and dynamic balance among elderly men. Procedia-Social and Behavioral Sciences, 46, 2220-2224. Bekiari, M., Iakovidis, P., Lytras, D., Chatziprodromidou, I. P., & Dimitros, E. (2021). The effect of hydrotherapy on the symptoms and functional characteristics of multiple sclerosis patients. Int J Phys Educ Sport Heal, 8(2), 191-197. Castro-Sánchez, A. M., Matarán-Peñarrocha, G. A., Lara-Palomo, I., Saavedra-Hernández, M., Arroyo-Morales, M., & Moreno-Lorenzo, C. (2012). Hydrotherapy for the treatment of pain in people with multiple sclerosis: a randomized controlled trial. Evidence-based complementary and alternative medicine, 2012. Dixon, J., Hatton, A. L., Robinson, J., Gamesby-Iyayi, H., Hodgson, D., Rome, K., ... & Martin, D. J. (2014). Effect of textured insoles on balance and gait in people with multiple sclerosis: an exploratory trial. Physiotherapy, 100(2), 142-149. Genova, H., Dacosta-Aguayo, R., Goverover, Y., Smith, A., Bober, C., & DeLuca, J. (2020). Effects of a Single Bout of Aquatic Exercise on Mood in Multiple SclerosisA Pilot Study. International Journal of MS Care, 22(4), 173-177. Hammill, H. V., Ellapen, T. J., Strydom, G. L., & Swanepoel, M. (2018). The benefits of hydrotherapy to patients with spinal cord injuries. African journal of disability, 7(1), 1-8. Kahraman, T., Rasova, K., Jonsdottir, J., Medina, C. S., Kos, D., Coote, S., ... & Kalron, A. (2022). The impact of the COVID-19 pandemic on physical therapy practice for people with multiple sclerosis: A multicenter survey study of the RIMS network. Multiple Sclerosis and Related Disorders, 62, 103799. Kargarfard, M., Etemadifar, M., Baker, P., Mehrabi, M., & Hayatbakhsh, R. (2012). Effect of aquatic exercise training on fatigue and health-related quality of life in patients with multiple sclerosis. Archives of physical medicine and rehabilitation, 93(10), 1701-1708. Kubsik-Gidlewska, A. M., Klimkiewicz, P., Klimkiewicz, R., Janczewska, K., & Woldańska-Okońska, M. Z. (2017). Rehabilitation in multiple sclerosis. Advances in Clinical and Experimental Medicine, 26(4). Lambeck, J. (2017). Hydrotherapy in adult neurology. EWAC Medical http://www. ewac. com. Accessed, 10. Mooventhan, A., & Nivethitha, L. (2014). Scientific evidence-based effects of hydrotherapy on various systems of the body. North American journal of medical sciences, 6(5), 199. Ormstad, H., Simonsen, C. S., Broch, L., Maes, M., Anderson, G., & Celius, E. G. (2020). Chronic fatigue and depression due to multiple sclerosis: Immune-inflammatory pathways, tryptophan catabolites and the gut-brain axis as possible shared pathways. Multiple sclerosis and related disorders, 46, 102533. Tan, Z., Liu, H., Yan, T., Jin, D., He, X., Zheng, X., ... & Tan, C. (2014). The effectiveness of functional electrical stimulation based on a normal gait pattern on subjects with early stroke: a randomized controlled trial. BioMed research international, 2014.

Responsible Party:

Konstantinos Chandolias, Post Doc Researcher, University of Thessaly

ClinicalTrials.gov Identifier:

NCT06121648

Other Study ID Numbers:

6006

First Posted:

Nov 8, 2023

Last Update Posted:

Nov 9, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Nov 9, 2023