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Clinical Trials/NCT07006259
NCT07006259CompletedNot Applicable

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

Universidad Rey Juan Carlos1 site in 1 country45 target enrollmentStarted: September 26, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
45
Locations
1
Primary Endpoint
Balance Evaluation Systems Test (Mini BESTest).

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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+.

Exclusion Criteria

  • •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.

Arms & Interventions

Control group

Experimental

Treatment with bobath Therapy

Intervention: Bobath Therapy (Other)

Experimental group A

Active Comparator

Bobath Therapy plus Virtual Reality

Intervention: Bobath therapy plus virtual reality (Other)

Experimental group B

Active Comparator

Home exercises

Intervention: Home exercises (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Timed Up and Go Test(At the beginning, at the month and we would reevaluate after 15 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Josue Fernandez Carnero

Principal Investigator

Universidad Rey Juan Carlos

Study Sites (1)

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