Multiple SclerosisNCT06121648
Effect of Hydrotherapy on Multiple Sclerosis
A study testing hydrotherapy and neurological physiotherapy in people with Multiple Sclerosis, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 42 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- hydrotherapy and neurological physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2023to 15 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 42 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hydrotherapy on the Balance and Fatigue of Multiple Sclerosis Patients
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- hydrotherapy, neurological physiotherapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrotherapyOther
30 degrees temperature pool balance and breathing therapy
neurological physiotherapyOther
Balance and neurological physiotherapy on land
| Study group | Role | What they receive |
|---|---|---|
| Water Group | Experimental | Static and dynamic balance, breathing, combined breathing and movement activities. Receives: Other: hydrotherapy |
| Land Group | Active comparator | Intervention program focused on balance and gait. Receives: Other: neurological physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Sep 2023
- Primary completion26 Nov 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups 1. water group 2. land group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Chandolias, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121648
- Sponsor's protocol ID
- 6006
- Status last verified
- Dec 2025
- First submitted
- 2 Nov 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hydrotherapy on the Balance and Fatigue of Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT06121648
- Acronym / sponsor ID
- 6006
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 26 Nov 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups 1. water group 2. land group
| Arm | Type | Receives |
|---|---|---|
| Water Group | Experimental | Other: hydrotherapyStatic and dynamic balance, breathing, combined breathing and movement activities. |
| Land Group | Active comparator | Other: neurological physiotherapyIntervention program focused on balance and gait. |
Who may qualify
- Ages
- 23 to 42 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrotherapy30 degrees temperature pool balance and breathing therapy | Other | Water Group |
| neurological physiotherapyBalance and neurological physiotherapy on land | Other | Land Group |
Primary outcome
BBS scale
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Background1.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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydrotherapy and neurological physiotherapy in people with Multiple Sclerosis, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BBS scale (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06121648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.