Eficacia de un Programa de rehabilitación Basado en Las Dimensiones Del Equilibrio en Personas Con daño Cerebral Adquirido: Ensayo clínico Aleatorizado
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).
Study Overview
Brief Summary
The purpose of this clinical trial is to find out whether a rehabilitation program based on different dimensions of balance can improve balance, mobility, walking ability, and quality of life in people with acquired brain injury.
The main questions this study aims to answer are:
- Does this rehabilitation program improve balance?
- Does it improve mobility and walking ability?
- Does it reduce the risk of falls?
- Does it improve quality of life?
Researchers will compare a specific balance rehabilitation program with conventional physiotherapy to determine whether the balance program provides additional benefits.
Participants with acquired brain injury who meet the eligibility criteria will be randomly assigned to one of two groups. Both groups will receive treatment for 12 weeks.
Participants will:
- Complete balance and mobility assessments before starting treatment.
- Receive either the balance rehabilitation program or conventional physiotherapy five times per week.
- Complete assessments immediately after treatment and again 6 and 12 weeks later.
The information obtained from this study may help improve rehabilitation programs and daily functioning for people with acquired brain injury.
Detailed Description
Acquired brain injury (ABI) is a major cause of disability in adults. It can affect balance, walking, mobility, independence in daily activities, and quality of life. Balance problems are common after ABI and may increase the risk of falls.
This study will evaluate a rehabilitation program based on different dimensions of balance in people with ABI. The program is designed to work on proprioception, biomechanical constraints, limits of stability, anticipatory postural adjustments, reactive postural responses, sensory orientation, and dynamic gait stability.
This is a prospective, longitudinal, randomized controlled trial with assessor blinding. The study will include 68 adults with ABI who are receiving active rehabilitation at the State Reference Centre for Brain Injury Care (CEADAC) in Madrid, Spain. Participants will be randomly assigned to one of two groups.
The experimental group will receive a structured multimodal balance rehabilitation program. The control group will receive conventional physiotherapy according to the usual clinical protocols at CEADAC. Both groups will receive treatment for 12 weeks, with five 60-minute sessions per week.
The main outcome will be balance performance, assessed with the Balance Evaluation Systems Test adapted for Acquired Brain Injury (BESTest_DCA). Secondary outcomes will include mobility, walking speed, fall risk, and quality of life, assessed with the Timed Up and Go Test, the 10-Meter Walk Test, and the CAVIDACE questionnaire (Spanish Quality of Life Questionnaire for People with Acquired Brain Injury).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors will be blinded to group allocation. Due to the nature of the intervention, participants and physiotherapists delivering the treatments cannot be blinded. Outcome assessments will be performed by an independent evaluator who will not have access to treatment allocation information. Statistical analyses will be conducted using anonymized data coded by group.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 to 65 years.
- •Diagnosis of acquired brain injury (stroke, traumatic brain injury, anoxic brain injury, brain tumor, or encephalitis).
- •At least 2 months since the brain injury.
- •Mini-Mental State Examination (MMSE) score greater than
- •Modified Rankin Scale (mRS) score of 3 or lower.
- •Ability to walk independently or with an assistive device.
- •Clinical stability and ability to participate in a rehabilitation program.
- •Written informed consent signed by the participant.
Exclusion Criteria
- •Severe cognitive impairment (MMSE score of 24 or lower).
- •Severe functional dependence (mRS score greater than 3).
- •Unstable medical conditions that may interfere with participation.
- •Severe musculoskeletal, cardiovascular, or other conditions that prevent safe participation in the intervention.
- •Severe communication disorders that prevent understanding of study procedures.
- •Participation in another clinical trial that may interfere with the study results.
Outcomes
Primary Outcomes
Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).
Time Frame: Baseline and 12 weeks (end of intervention)
Change in balance performance measured using the Spanish adaptation of the Balance Evaluation Systems Test (BESTest\_DCA), previously validated in people with acquired brain injury. The test evaluates six balance control systems and provides a total score ranging from 0 to 108 points. Higher scores indicate better balance performance.
Secondary Outcomes
- Walking speed assessed with the 10-Meter Walk Test (10MWT)(Baseline, 12 weeks, 6-week follow-up and 12-week follow-up)
- Mobility assessed with the Timed Up and Go test (TUG)(Baseline, 12 weeks, 6-week follow-up and 12-week follow-up)
- Quality of life assessed with the CAVIDACE scale(Baseline and 12 weeks)
- Number of falls(During the 12-week intervention and 12-week follow-up period)