Effect of Dual-Task Training on Balance and Fall Risk in Lower Limb Amputees Using Prosthesis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKafrelsheikh University
About this trial
This prospective randomized controlled trial aims to investigate the effect of dual-task training on balance and fall risk in individuals with unilateral transfemoral amputation using a prosthesis. Forty participants aged 18-60 years will be randomly allocated to either an experimental group receiving dual-task training in addition to conventional therapy or a control group receiving conventional therapy alone. The intervention will be conducted for 8 weeks, 3 sessions per week. Balance and fall risk will be evaluated before and after the intervention using the Biodex Stability System, Berg Balance Scale, and Timed Up and Go Test.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ranging from 18 to 60 years.
Unilateral transfemoral amputation.
Use of a prosthetic limb for at least 6 months.
Ability to walk independently with or without assistive devices.
Disqualifiers
Bilateral amputation.
Severe visual or vestibular disorders.
Neurological conditions (e.g., stroke, Parkinson's disease)
Cognitive impairment affecting task performance.
Trial design
Design model
Parallel
Treatments tested in this trial
Dual-task training
BehavioralParticipants will receive progressive dual-task training combined with conventional physiotherapy. The intervention includes simultaneous motor-cognitive and motor-motor tasks such as walking while counting backward, naming categories, carrying objects during walking, obstacle negotiation, and ball passing. Training will be provided three sessions per week for 8 weeks.
Conventional Physiotherapy
Other interventionParticipants will receive conventional physiotherapy including strengthening exercises, balance training, gait training with the prosthesis, weight-shifting exercises, and functional mobility training for 8 weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Balance assessed using the Biodex Stability System Overall Stability Index (OSI)
Balance will be evaluated using the Biodex Stability System by measuring the Overall Stability Index (OSI). Lower OSI values indicate better postural stability. Assessments will be performed before and after the 8-week intervention.
Time frame
Baseline and after 8 weeks of interventionSecondary outcomes
1
Berg Balance Scale (BBS)
Balance will be assessed using the Berg Balance Scale (BBS). Higher scores indicate better balance performance.
Time frame
Baseline and after 8 weeksSponsors and contacts
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Source ClinicalTrials.gov
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