Balance Dimensions-Based Rehabilitation Program in People With Acquired Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Castilla-La Mancha
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 24.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Multimodal Balance Rehabilitation Program
BehavioralA multimodal rehabilitation program based on balance dimensions designed to improve balance performance in people with acquired brain injury.
Conventional Physiotherapy
Other interventionConventional physiotherapy routinely provided at CEADAC according to standard clinical practice.
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Balance performance assessed using the Spanish adaptation of the Balance Evaluation Systems Test validated in people with acquired brain injury (BESTest_DCA).
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.
Time frame
Baseline and 12 weeks (end of intervention)Secondary outcomes
1
Mobility assessed with the Timed Up and Go test (TUG)
Change in functional mobility measured using the Timed Up and Go (TUG) test. The test records the time required to stand up from a chair, walk 3 meters, turn, walk back, and sit down. Scores are measured in seconds. Lower scores indicate better functional mobility.
Time frame
Baseline, 12 weeks, 6-week follow-up and 12-week follow-up2
Walking speed assessed with the 10-Meter Walk Test (10MWT)
Change in walking speed measured using the 10-Meter Walk Test (10MWT). Walking speed is calculated in meters per second (m/s). Higher walking speed indicates better walking performance.
Time frame
Baseline, 12 weeks, 6-week follow-up and 12-week follow-up3
Quality of life assessed with the CAVIDACE scale
Change in quality of life measured using the CAVIDACE Scale (proxy version). The scale consists of 64 items scored from 0 to 3, with a total score ranging from 0 to 192 points. Higher scores indicate better perceived quality of life.
Time frame
Baseline and 12 weeks4
Number of falls
Number of falls reported during the intervention and follow-up period.
Time frame
During the 12-week intervention and 12-week follow-up periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Castilla-La Mancha
Lead sponsor
Centro de Referencia Estatal de Atención Al Daño Cerebral
Collaborator
Source ClinicalTrials.gov
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