NCT06121648

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable multiple-sclerosis

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

September 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 2, 2023

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • BBS scale

    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.

    2 months

  • MFIS scale

    The total MFIS score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales.

    2 months

Study Arms (2)

Water Group

EXPERIMENTAL

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

Other: hydrotherapy

Land Group

ACTIVE COMPARATOR

Intervention program focused on balance and gait.

Other: neurological physiotherapy

Interventions

30 degrees temperature pool balance and breathing therapy

Water Group

Balance and neurological physiotherapy on land

Land Group

Eligibility Criteria

Age23 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Thessaly

Lamía, Central Macedonia, 35100, Greece

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

HydrotherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
closed envelopes
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups 1. water group 2. land group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Doc Researcher

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 8, 2023

Study Start

September 1, 2023

Primary Completion

November 26, 2023

Study Completion

December 15, 2023

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations