Effect of Bobath Therapy on Balance Alterations in Patients With Multiple Sclerosis

NCT07006259 | Completed DMC

• 1 other identifier: Neurofis
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. As a secondary objective, we seek to know the state of the art of Bobath therapy in Multiple Sclerosis.

Conditions

Bobath Therapy; Postural Control; Virtual Reality; Home Exercise Program

Outcome Measures

Primary Outcomes (1)

• 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.

  At the beginning, at the month and we would reevaluate after 15 days

Secondary Outcomes (1)

• Timed Up and Go Test

  At the beginning, at the month and we would reevaluate after 15 days

Other Outcomes (5)

• Functional reach test (FRT)

  At the beginning, at the month and we would reevaluate after 15 days

• Modified Fatigue Impact Scale (MFIS)

  At the beginning, at the month and we would reevaluate after 15 days

• MusiQoL

  At the beginning, at the month and we would reevaluate after 15 days

Study Arms (3)

Control group

EXPERIMENTAL

Treatment with bobath Therapy

Other: Bobath Therapy

Experimental group A

ACTIVE COMPARATOR

Bobath Therapy plus Virtual Reality

Other: Bobath therapy plus virtual reality

Experimental group B

ACTIVE COMPARATOR

Home exercises

Other: Home exercises

Interventions

Bobath Therapy OTHER

Treatment with bobath therapy

Control group

Bobath therapy plus virtual reality OTHER

Treatment with bobath therapy plus virtual reality

Experimental group A

Home exercises OTHER

Treatment with home exercises

Experimental group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• = 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+.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 5, 2025
• Study Start: September 26, 2024
• Primary Completion: January 26, 2025
• Study Completion: March 26, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Locations

ES (1)