Bobath Therapy, Postural Control, Virtual Reality, Home Exercise Program
Conditions
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.
Interventions
OTHERBobath Therapy
Treatment with bobath therapy
OTHERBobath therapy plus virtual reality
Treatment with bobath therapy plus virtual reality
OTHERHome exercises
Treatment with home exercises
Sponsors
Universidad Rey Juan Carlos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age: over 18 years old. 2. Have a diagnosis of multiple sclerosis, according to Mc Donald criteria at least 6 months before the start of the intervention. 3. 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
1. Participants who are not able to understand instructions, 2. 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. 3. Participants with visual disturbances or severe upper limb involvement who therefore have difficulty using the VR glasses or performing reaching exercises with them.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance Evaluation Systems Test (Mini BESTest). | 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
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test | At the beginning, at the month and we would reevaluate after 15 days | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| MusiQoL | At the beginning, at the month and we would reevaluate after 15 days | The Spanish version of the MusiQoL questionnaire appears to be a valid and reliable instrument for measuring quality of life in MS patients in Spain and is a useful tool for measuring health-related quality of life in the clinical setting. The MusiQoL is a questionnaire used to assess quality of life in people with multiple sclerosis. To score, the responses to the items are added together to obtain a total score, which can range from 0 to 100. The higher the score, the higher the perception of quality of life. |
| Functional reach test (FRT) | At the beginning, at the month and we would reevaluate after 15 days | It is one of the most widely used balance scales because it measures the limits of stability in standing. It also identifies limitations in activities of daily living (ADLs) and indicates the risk of falls. The final FRT score is the distance between the initial and final positions. Results of less than 25 cm indicate a limitation in ADLs and a risk of falls. |
| Computerized dynamic posturography (PDC). | At the beginning, at the month and we would reevaluate after 15 days | It is a quantitative method for the assessment and treatment of balance disorders. It is based on the use of dynamometric platforms that measure the displacement of the center of pressure by collecting the sensors located on it, the different pressure stimuli exerted by the subject's body in different static and dynamic situations and is considered by several authors as the gold standard for the study of postural control. |
| Neo-plate pressure platform | At the beginning, at the month and we would reevaluate after 15 days | A static analysis of pressure distribution will be performed with the patient standing, differentiating between forefoot and hindfoot loads, and between the right and left feet, as well as by quadrant, and quantifying the deviation from the center of pressure position. A dynamic analysis will be performed during gait, recording contact time, average pressure, and the time/contact integral. Several studies demonstrate the use of pedometric platforms to assess and improve gait and balance disorders in patients with MS. The Neo-plate pressure platform can measure mean and maximum pressures in kPa, stabilometry and oscillation data of the center of pressure in mm/s and the force exerted by the foot during walking in kg. |
| Modified Fatigue Impact Scale (MFIS) | At the beginning, at the month and we would reevaluate after 15 days | The MFIS uses a multidimensional approach with cognitive, physical, and psychosocial components. It consists of approximately 21 items in the form of questions related to the patient's feeling of fatigue. The maximum possible score is 84, with higher scores indicating a greater impact on quality of life. |
Countries
Spain
Outcome results
None listed