Bobath TherapyBTPCMSNCT07006259
Effect of Bobath Therapy on Balance Alterations in Patients With Multiple Sclerosis
A study testing Bobath Therapy, Bobath therapy plus virtual reality and Home exercises in people with Bobath Therapy and Postural Control, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
To evaluate the effects of a foot treatment to improve balance according to the Bobath Concept in people with Multiple sclerosis, comparing it with treatment through home exercise and with treatment from Bobath Concept combined with the use of virtual reality. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bobath Therapy, Postural Control, Virtual Reality
- What is being tested?
- Bobath Therapy, Bobath therapy plus virtual reality and Home exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 26 Sep 2024to 26 Mar 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: over 18 years old.
- Have a diagnosis of multiple sclerosis, according to Mc Donald criteria at least 6 months before the start of the intervention.
- Be able to walk independently in a closed environment with or without technical aids, having a maximum score of 6.5 on the Expanded Disability Status Scale or EDSS, according to its acronym in English:
- 6.5= constant bilateral help (canes, crutches or braces) to walk about 20 meters without rest. The usual functional system (FS) is equivalent to combinations with more than two FS of grade 3+.
Who cannot join
- Participants who are not able to understand instructions,
- Participants who are in a clinically unstable situation or who have risk factors or concomitant pathologies of the musculoskeletal system, neurological or cardiovascular, which make it difficult to carry out the treatment.
- Participants with visual disturbances or severe upper limb involvement who therefore have difficulty using the VR glasses or performing reaching exercises with them.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effects of a foot treatment to improve balance according to the Bobath Concept in people with Multiple sclerosis, comparing it with treatment through home exercise and with treatment from Bobath Concept combined with the use of virtual reality.
As a secondary objective, we seek to know the state of the art of Bobath therapy in Multiple Sclerosis.
- Being tested
- Bobath Therapy, Bobath therapy plus virtual reality, Home exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath TherapyOther
Treatment with bobath therapy
Bobath therapy plus virtual realityOther
Treatment with bobath therapy plus virtual reality
Home exercisesOther
Treatment with home exercises
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Treatment with bobath Therapy Receives: Other: Bobath Therapy |
| Experimental group A | Active comparator | Bobath Therapy plus Virtual Reality Receives: Other: Bobath therapy plus virtual reality |
| Experimental group B | Active comparator | Home exercises Receives: Other: Home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Evaluation Systems Test (Mini BESTest).
It assesses balance in six items (biomechanical restrictions, stability and verticality limits, anticipatory postural adjustments, postural responses, sensory orientation, and gait stability). It has excellent inter- and intra-observer reliability and construct validity in stroke patients. Furthermore, the items on anticipatory postural adjustments and sensory orientation are highly correlated with the risk of falls in this type of pathology.
Measured: At the beginning, at the month and we would reevaluate after 15 days
Secondary outcomes (1)
Timed Up and Go Test
It assesses the risk of falls. It allows the measurement of functional movement. It has excellent inter- and intra-observer reliability and good construct validity. A test duration of more than 13.5 seconds is associated with an elevated risk of falls
Measured: At the beginning, at the month and we would reevaluate after 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start26 Sep 2024
- Primary completion26 Jan 2025
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bobath TherapyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006259
- Sponsor's protocol ID
- Neurofis
- Acronym
- BTPCMS
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bobath Therapy on Balance Alterations in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT07006259
- Acronym / sponsor ID
- BTPCMS / Neurofis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 5 Jun 2025 (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.
To evaluate the effects of a foot treatment to improve balance according to the Bobath Concept in people with Multiple sclerosis, comparing it with treatment through home exercise and with treatment from Bobath Concept combined with the use of virtual reality.
As a secondary objective, we seek to know the state of the art of Bobath therapy in Multiple Sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Other: Bobath TherapyTreatment with bobath Therapy |
| Experimental group A | Active comparator | Other: Bobath therapy plus virtual realityBobath Therapy plus Virtual Reality |
| Experimental group B | Active comparator | Other: Home exercisesHome exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: over 18 years old.
- Have a diagnosis of multiple sclerosis, according to Mc Donald criteria at least 6 months before the start of the intervention.
- Be able to walk independently in a closed environment with or without technical aids, having a maximum score of 6.5 on the Expanded Disability Status Scale or EDSS, according to its acronym in English:
- 6.5= constant bilateral help (canes, crutches or braces) to walk about 20 meters without rest. The usual functional system (FS) is equivalent to combinations with more than two FS of grade 3+.
Key exclusion criteria (3 listed)
- Participants who are not able to understand instructions,
- Participants who are in a clinically unstable situation or who have risk factors or concomitant pathologies of the musculoskeletal system, neurological or cardiovascular, which make it difficult to carry out the treatment.
- Participants with visual disturbances or severe upper limb involvement who therefore have difficulty using the VR glasses or performing reaching exercises with them.
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 |
|---|---|---|
| Bobath TherapyTreatment with bobath therapy | Other | Control group |
| Bobath therapy plus virtual realityTreatment with bobath therapy plus virtual reality | Other | Experimental group A |
| Home exercisesTreatment with home exercises | Other | Experimental group B |
Primary outcome
Balance Evaluation Systems Test (Mini BESTest).
Time frame: At the beginning, at the month and we would reevaluate after 15 days
It assesses balance in six items (biomechanical restrictions, stability and verticality limits, anticipatory postural adjustments, postural responses, sensory orientation, and gait stability). It has excellent inter- and intra-observer reliability and construct validity in stroke patients. Furthermore, the items on anticipatory postural adjustments and sensory orientation are highly correlated with the risk of falls in this type of pathology.
1 secondary outcome
Timed Up and Go Test
Time frame: At the beginning, at the month and we would reevaluate after 15 days
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 5 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Bobath Therapy
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Not yet recruiting
Early Intervention in Cerebral Palsy: Perception-Action vs Neurodevelopmental Therapy
Cerebral Palsy, Cerebral Palsy Early Intervention
Not yet recruiting
The Effectiveness of Neurodevelopmental Treatment (Bobath) and Functional Physiotherapy in Children With Cerebral Palsy.
Cerebral Palsy (CP)
Not yet recruiting
Spinal Mobility in Children With Cerebral Palsy: NDT-Bobath and Exergaming
Spastic Diplegia Cerebral Palsy, Spastic Hemiplegia
Not yet recruiting
Virtual Reality Combined With Bobath Therapy for Spastic Cerebral Palsy
Spastic Cerebral Palsy (sCP)
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 Bobath Therapy, Bobath therapy plus virtual reality and Home exercises in people with Bobath Therapy and Postural Control, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 4 inclusion and 3 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 5 Jun 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 Spain. 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?
Balance Evaluation Systems Test (Mini BESTest). (time frame: At the beginning, at the month and we would reevaluate after 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2025.